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Featured Studies

Featured studies include only those currently recruiting participants. Studies with the most recent start date appear first.


Improving HIV Adherence Care for Key Populations in India 

Study Type: Interventional
Start Date: December 6, 2023
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): The Humsafar Trust, Mumbai, India

This study seeks to adapt and pilot test a comprehensive wellness program to address the barriers to engagement in the HIV care continuum among men who have sex with men (MSM) and transgender women (TGW) in India. The content involves an adaptation of the earlier Chetana wellness adherence intervention which was found to successfully improve adherence and viral suppression among mainstream Indian persons living with HIV (PLWH). Based on the initial formative work, the adaptation includes added wellness group content and will be offered in a flexible format. It also uses peer navigators (PN), rather than Master-level counselors, to deliver tailored support at mutually convenient times and places. This PN model has been used successfully by Indian collaborators and in previous research in South Africa to link and retain PLWH in care. The intervention is intended to break the link between stigma and care seeking, which is especially important for key populations (KPs), who must deal with historically hostile legal environments and substantial isolation that further reduces engagement in HIV preventive practices and services .

Investigators are conducting this research to address the following aims:

1) To engage community stakeholders in the adaptation and pilot testing of the Chetana-PN wellness adherence intervention for use with Indian MSM and TGW who are living with HIV and who are newly or insufficiently engaged in care.

2a) To assess in a small randomized control trial (RCT) the acceptability and feasibility of the theoretically-guided, adapted intervention and to obtain preliminary effect size estimations for the impact of the intervention on engagement in care, among MSM and TGW.

2b) To characterize participant and navigator experiences in the Chetana-PN intervention and describe the practices that were most successful at overcoming barriers to care with 25 participants who received the Chetana-PN intervention and the peer navigators. These findings will subsequently be used to inform a future RCT designed to establish the efficacy of this adapted Chetana-PN intervention for sexual minorities in India.


Enhancing Mental Health Outcomes for Patients With Psychosis in Malawi Through Community-based Rehabilitation 

Study Type: Interventional
Start Date: December 4, 2023
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): Queen Elizabeth Central Hosptial, Blantyre, Malawi

The overall aim of the proposed study is to determine the feasibility, acceptability, fidelity, and preliminary effectiveness of the adapted nurse-led, community-based rehabilitation treatment model for community-dwelling individuals living with psychosis in Blantyre, Malawi using a pilot randomized controlled trial.


Executive Function and Parenting in Childhood 

Study Type: Interventional
Start Date: November 20, 2023
Eligibility: 4 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Illinois-Chicago, Chicago, Illinois, United States

Deficits in executive functioning (EF) disproportionately impact children living in poverty and increase risk for psychopathology, particularly disruptive behavior disorders. This randomized clinical trial seeks to determine whether childhood EF, assessed across neural and behavioral units of analysis, is an experimental therapeutic target that can be directly modified through caregiver participation in the Chicago Parent Program (CPP), if increases in EF predict reduced disruptive behavior trajectories in low-income children over a short-term follow-up period, and identify which CPP-driven parenting skill improvements are the most influential in modifying EF. This work will contribute new knowledge as to whether a cost-efficient parenting intervention, developed for and with low-income families raising young children in poverty, can modify EF, a neural behavioral mechanism implicated in risk for childhood disruptive behavior problems.


The Computational and Neural Mechanisms Linking Decision-making and Memory in Humans 

Study Type: Interventional
Start Date: October 31, 2023
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Mount Sinai West, New York, New York, United States

Learning to make good decisions in the present, and accurately recalling events and information from the past, are critical aspects of human cognition that are often impaired in many psychiatric disorders. This project aims to identify the how the choices individuals make influence what, and how, people remember by combining disparate techniques in computational modeling and direct brain recordings in human subjects. The researcher developed a dual-task paradigm, probing how decisions in one task affect immediate recognition memory. To examine the neural mechanisms underlying model-free RL's influence on memory, the researcher will record local field potential (LFP) and single neuron activity in various brain regions as epilepsy patients perform the proposed task. The results of this project will identify specific neurocomputational mechanisms unifying decision-making and memory processes.


Investigating Electroencephalographic Predictors of Default Mode Network Anticorrelation in Healthy Adults 

Study Type: Interventional
Start Date: October 6, 2023
Eligibility: 18 Years to 35 Years, Accepts Healthy Volunteers
Location(s): Drexel University, Philadelphia, Pennsylvania, United States

Healthy adult subjects will participate in two sessions. The first session will involve measurements of brain activity using simultaneous recordings with electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI). During brain activity measurement, participants will perform cognitive tasks assessing attention. The second will involve fMRI-based neurofeedback during simultaneous EEG-fMRI recording. Participants will receive real-time visual feedback of signals measured from specific parts of their brain and will try to control that activity.


Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis 

Study Type: Interventional
Start Date: October 3, 2023
Eligibility: Females, 17 Years and Younger, Does Not Accept Healthy Volunteers
Location(s): Site 5115, Siriraj Hospital, Mahidol University NICHD CRS, Bangkok Noi, Thailand; Site 31976, PHRU Matlosana CRS, Klerksdorp, North West Province, South Africa; Site 31790, Desmond Tutu TB Centre (DTTC) CRS, Cape Town, South Africa; Site 31929, Sizwe CRS, Johannesburg, South Africa

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a single dose of pretomanid, added to an optimized background tuberculosis treatment regimen (OBR), in children with rifampicin-resistant tuberculosis (RR-TB) with or without human immunodeficiency virus (HIV).


MRI Neurofeedback and Brain Circuits Related to Motivation in Healthy Participants 

Study Type: Interventional
Start Date: July 30, 2023
Eligibility: 18 Years to 45 Years, Accepts Healthy Volunteers
Location(s): Center for Cognitive Neuroscience, Durham, North Carolina, United States

The purpose of this research study is to understand how healthy individuals self-regulate motivation by observing brain activity using magnetic resonance imaging (MRI).


TEAMS R34 #1 After-Action Reviews in Child Welfare Services 

Study Type: Interventional
Start Date: July 28, 2023
Eligibility: 6 Years and Older, Does Not Accept Healthy Volunteers
Location(s): UC San Diego - IN STEP Children's Mental Health Research Center, San Diego, California, United States

This project proposes to improve successful mental health service linkage in Child Welfare Services (CWS) by adapting and testing the After Action Review (AAR) team effectiveness intervention to augment the Child Family Team (CFT) services intervention. Despite being both required and a collaborative approach to service planning, CFT meetings are implemented with questionable fidelity and consistency, rarely including children and families as intended. By inclusion of child and family voice, the AAR-enhanced CFT should lead to increased fidelity to the CFT intervention and greater levels of parental satisfaction with the service and shared decision-making, thus resulting in enhanced follow-through with Action Plans and linkage to mental health care for children.


State-dependent Interoception, Value-based Decision-making, and Introspection 

Study Type: Interventional
Start Date: July 25, 2023
Eligibility: 18 Years to 55 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Negative emotional states can affect a person s behavior as they make decisions. For example, hunger may make people more impatient; they may then make riskier choices. Other negative emotional states that can change behavior include stress, pain, and sadness. By learning more about how emotions affect thinking and behavior in healthy people, researchers hope to better understand how to identify and treat people with mental disorders.

Objective:

To learn how negative emotions affect the brain and decision-making behavior.

Eligibility:

Healthy people aged 18 to 55 years.

Design:

Participants will have 3 clinic visits in 3 weeks.

Participants will fill out questionnaires. They will be asked about their personal history, their personality, and state of mind.

For 2 visits, participants will be assigned to different groups. Each group will experience 3 type of emotional stressor:

Some participants will watch a video.

Some will have to do arithmetic problems.

Some will have heat applied to an arm or leg.

Some will experience cold by immersing their hand in ice water.

For a snack craving test, some will be tempted by food after a 4-hour fast.

During these tests, participants will have sensors attached to their bodies. They will be videotaped. Saliva samples will be collected.

After the stressors, participants will do tasks on a computer. They will need to make choices.

Some participants will perform these decision-making tasks while lying in a brain scanner for functional magnetic resonance imaging. The brain scan involves lying on a table that slides into a cylinder that takes images of the brain.


Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis 

Study Type: Interventional
Start Date: July 21, 2023
Eligibility: 14 Years to 25 Years, Does Not Accept Healthy Volunteers
Location(s): Icahn School of Medicine at Mount Sinai, New York, New York, United States

This study aims to evaluate the feasibility and effectiveness of telehealth interventions for individuals at clinical high risk for psychosis (CHR). Psychosis typically emerges during late adolescence or early adulthood, significantly impacting long-term functioning. While CHR programs have the potential to reduce illness severity, individuals often face barriers such as stigma and limited access to services. Telehealth interventions could address these barriers and improve treatment accessibility and engagement. The study will focus on Group and Family-Based Cognitive Behavioral Therapy, Family-Based CBT, and individual CBT, adapted for telehealth delivery (GF-CBT-TH, F-CBT-TH, and I-CBT-TH). Participants aged 14-25 who meet CHR criteria will be randomly assigned to one of these interventions. Feasibility will be measured by recruitment rate, attendance, and retention. The study will assess the impact of the interventions on cognitive biases, social connectedness, family emotional climate, and proficiency in CBT skills. The three intervention groups will be compared in terms of psychosocial functioning, symptom severity, rates of remission from CHR, and rates of transition to psychosis. Additionally, factors like patient treatment preference, family emotional climate, and sociodemographic factors will be explored as potential moderators of treatment outcomes. Qualitative interviews will be conducted with participants and clinicians to inform dissemination efforts.


mHealth for Psychosis Help-seeking 

Study Type: Interventional
Start Date: June 15, 2023
Eligibility: 18 Years to 30 Years, Does Not Accept Healthy Volunteers
Location(s): University of Washington, Seattle, Washington, United States

The proposed study research project aims to develop and test a mobile health intervention designed to improve the wellness of young people at risk for psychosis and facilitate users' engagement with treatment and thus reduce duration of untreated psychosis. This clinical trial will involve a remote pilot randomized controlled trial that will examine (1) the feasibility of the proposed research approach, (2) the acceptability and usability of the NORTH intervention as well as (3) the specific additive value of help-seeking support in the context of self-guided mHealth for early psychosis. The full intervention, which includes psychoeducational lessons, Cognitive-Behavior Therapy-based practices, a symptom tracking feature, and help-seeking resources will be compared to a "Lite" version that will include the lessons, practices, and tracking but exclude the help-seeking resources.


Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes 

Study Type: Interventional
Start Date: May 30, 2023
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Charak Research Center, Garfield Heights, Ohio, United States; Fermata Helath, Brooklyn, New York, United States

The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia.


CNS Correlates of Extended Sleep Restriction 

Study Type: Observational
Start Date: May 23, 2023
Eligibility: 18 Years to 39 Years, Accepts Healthy Volunteers
Location(s): Walter Reed Army Institute of Research, Silver Spring, Maryland, United States

Chronic sleep restriction is ubiquitous in both the general population and the military. The deleterious effects of sleep loss on human alertness and cognitive performance have been documented in numerous studies dating back to the nineteenth century. Over the past decade, evidence has emerged indicating that chronic sleep restriction may also precipitate deleterious, long lasting neuropathological changes in the brain. The purpose of this study is to determine neuropathological effects of sleep restriction and identify physiological mechanisms that correlate with sleep loss-induced performance impairment.


iTBS/fMRI Study of Hierarchical Control in the PFC 

Study Type: Interventional
Start Date: May 15, 2023
Eligibility: 18 Years to 30 Years, Accepts Healthy Volunteers
Location(s): FSU MRI Facility, Tallahassee, Florida, United States; Florida State University Psychology Department Building, Tallahassee, Florida, United States

The objective of this study is to examine the effect of transcranial magnetic stimulation (TMS) on the prefrontal cortex and posterior parietal cortex.


Reducing the Duration of Untreated Psychosis in the United States: The Impact of Screening and Systematic Communication 

Study Type: Interventional
Start Date: May 1, 2023
Eligibility: 12 Years to 30 Years, Does Not Accept Healthy Volunteers
Location(s): Icahn School of Medicine at Mount Sinai, New York, New York, United States

The goal of this project is to investigate whether a systematic screening approach enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych) can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first episode psychosis (FEP) cases, rapid referral to specialty care and engagement in treatment. The study team will use a stepped-wedge cluster randomized controlled trial design to compare a systematic screening and communication method (SCM) to systematic screening method (SM) to evaluate whether SCM substantially reduces DUP. The study team hypothesize that: (1) SCM will result in a higher number of individuals initiating specialty services compared to SM; (2) The mean DUP of FEP individuals in SCM condition will be lower than the mean DUP of FEP individuals in SM condition, due to the reduced time to initiate FEP services. We will also conduct a qualitative study to examine implementation barriers and facilitators of SCM.


Influence of Stress on Encoding and Prediction 

Study Type: Interventional
Start Date: March 2, 2023
Eligibility: 18 Years to 45 Years, Accepts Healthy Volunteers
Location(s): Yale University, New Haven, Connecticut, United States

The purpose of this study is to investigate the neural mechanisms by which acute stress influences statistical learning and episodic encoding.


Advancing mHealth-supported Adoption and Sustainment of an Evidence-based Mental Health Intervention in Sierra Leone 

Study Type: Interventional
Start Date: February 15, 2023
Eligibility: 14 Years and Older, Accepts Healthy Volunteers
Location(s): Innovations for Poverty Action, Freetown, Sierra Leone

This study will examine a new implementation strategy for the Youth Readiness Intervention (YRI), an evidence-based mental health intervention. The strategy will (a) leverage a delivery setting (schools) and workforce (teachers) used effectively in low- and middle- income countries; and (b) innovate with technology and mHealth tools to enhance mental health service delivery quality. The YRI will be implemented as an extracurricular resilience-building after school activity in Sierra Leone. Teachers will deliver the YRI and receive either mobile phone-supported supervision or standard in-person supervision. Mobile-based supervision will integrate WhatsApp, a free cross-platform messaging and voice service used widely throughout Africa, with mHealth digital tools. The mHealth tools will support supervision through key features, including voice activated content, fillable forms (i.e., YRI fidelity checklist), and visual dashboards to monitor fidelity. A hybrid type 3 implementation-effectiveness design will allow for evaluation of both mobile phone-based supervision as a new implementation strategy, and clinical effectiveness of the YRI on youth mental and behavioral health as secondary outcomes.


Basic Experimental Study of Hippocampal Memory Functions 

Study Type: Interventional
Start Date: January 16, 2023
Eligibility: 18 Years to 45 Years, Accepts Healthy Volunteers
Location(s): Northwestern Memorial Hospital, Chicago, Illinois, United States; University of Chicago Medical Center, Chicago, Illinois, United States

This project tests the role of the human hippocampus in providing online representation of episodic content and providing the top-down signals to brain networks for visuospatial attention and visual processing needed to drive visual sampling for the formation of coherent episodic memories. This hypothesis will be tested in several experiments that measure and manipulate hippocampal activity within eye-tracking tasks designed to isolate the interplay between memory and visual sampling during memory formation. These experiments will be performed in individuals with epilepsy undergoing neurosurgical procedures as part of clinical care, as this provides invasive recordings of neural activity (intracranial electroencephalography, or "iEEG") from the hippocampus and other regions of interest with temporal resolution that matches the rapid pace of eye movements. The temporal resolution of iEEG is key to addressing the hypotheses concerning how the hippocampus drives visual sampling, in addition to responding to it. Direct electrical stimulation through the iEEG electrodes will also be used to test the necessary role of hippocampal processing in driving active visual sampling. By rigorously testing the role of hippocampus in interaction with large-scale networks during the process of memory formation that occurs via active sampling, this project aims to better understand mechanisms relevant to the disruptions of memory formation that occur in neurological and psychiatric disorders.


Implementation Supports to Reduce Burnout in Therapists Delivering Child Trauma EBPs 

Study Type: Interventional
Start Date: January 1, 2023
Eligibility: 3 Years to 99 Years, Accepts Healthy Volunteers
Location(s): San Diego State University, San Diego, California, United States

The majority of children exposed to early adversity and trauma do not have access to sustainably delivered evidence-based mental health programs (EBPs), despite the growing prevalence of large-scale multiple-EBP implementation efforts aimed at increasing access to these services. The objective of this proposal is to develop and test a package of implementation strategies designed to promote the sustained delivery of child trauma EBPs by reducing provider turnover through targeting the associated mechanisms of provider burnout and organizational psychological safety climate. Findings will have a significant public health impact by informing efforts to increase the sustained availability of child trauma EBPs, thereby improving outcomes for children exposed to trauma.


Family Peer Navigator for Early Psychosis for Black Families 

Study Type: Interventional
Start Date: January 1, 2023
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): New Journeys: Coordinated Specialty care, Seattle, Washington, United States

Building upon formative research, this mixed methods study will be conducted in three phases to develop, refine, and pilot-test a multi-component Family Peer Navigator model designed to increase access to and initial engagement in coordinated specialty care for early psychosis among Black/African American families.


Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children 

Study Type: Interventional
Start Date: November 15, 2022
Eligibility: 8 Years to 14 Years, Accepts Healthy Volunteers
Location(s): Communities in Schools of Galveston County, La Marque, Texas, United States; Dickinson Independent School District, Dickinson, Texas, United States; Communities in Schools Gulf South, New Orleans, Louisiana, United States; Coalition for Compassionate Schools, New Orleans, Louisiana, United States; Communities in Schools Palm Beach, West Palm Beach, Florida, United States; Bay District Schools, Panama City, Florida, United States; Boys and Girls Club of Manatee County, Bradenton, Florida, United States; CARE Connections, Houston, Texas, United States

Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.


Theta Phase-specific TMS to Modulate Prefrontal Activity 

Study Type: Interventional
Start Date: November 1, 2022
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): University of Minnesota, Minneapolis, Minnesota, United States

The purpose of this study is to evaluate the causal link between the phase of ongoing theta oscillations in the prefrontal cortex and approach/avoidance (Ap/Av) behavior in adults using theta phase-specific transcranial magnetic stimulation (TMS).


Neurofeedback From the Supplementary Motor Area for Tourette Syndrome 

Study Type: Interventional
Start Date: November 1, 2022
Eligibility: 10 Years to 16 Years, Does Not Accept Healthy Volunteers
Location(s): Yale University School of Medicine, New Haven, Connecticut, United States

This is a clinical trial where adolescents aged 10-16 years old with Tourette Syndrome (or chronic tic disorder) are randomized to receive either real-time functional magnetic resonance imaging (fMRI) neurofeedback targeting the supplementary motor area (for the experimental intervention) or real-time fMRI neurofeedback (NF) from a control region (for the control intervention).


Novel Methods for Implementing Measurement-Based Care for Youth in Low-resource Environments 

Study Type: Interventional
Start Date: October 25, 2022
Eligibility: 13 Years and Older, Accepts Healthy Volunteers
Location(s): KPWHRI, Seattle, Washington, United States

This study will visit 6 community mental health clinics in Washington state and work with clinic staff to find out if staff are regularly evaluating clinical outcomes using questionnaires (which is also called measurement-based care). The study team will partner with clinic staff to find out what makes using questionnaires difficult and then plan to improve the use of questionnaires. The study activities will include trainings, interviews, collaborative discussions, and interactive activities.


Effect of Nitrous Oxide on Aggression. 

Study Type: Interventional
Start Date: September 6, 2022
Eligibility: 21 Years to 55 Years, Accepts Healthy Volunteers
Location(s): Ohio State University Wexner Medical Center, Columbus, Ohio, United States

The goal of this experimental medicine clinical trial is to test the hypothesis that nitrous oxide inhalation will result in a change in neurocircuit function in healthy controls and in individuals with impulsive aggressive tendencies. The main question aims to answer are: Does Nitrous Oxide normalize brain circuit function in impulsively aggressive individuals 24 hours after inhalation. Participants will undergo a 60 minute inhalation session with 50% Nitrous Oxide (or room air at another session) and then undergo an fMRI scan 24 hours later. Researchers will compare healthy controls and impulsively aggressive individuals to see if Nitrous Oxide can normalize the function of cortico-limbic circuits in the latter group.


Development of a Training Intervention to Improve Mental Health Treatment for Gender Minority Youth 

Study Type: Interventional
Start Date: September 1, 2022
Eligibility: 12 Years and Older, Accepts Healthy Volunteers
Location(s): Boston College, Chestnut Hill, Massachusetts, United States

The overall goal of the larger 3-aim study is to develop and pilot test a training intervention to increase mental health providers' use of gender-affirming practices with gender minority youth (GMY; children, adolescents, and young adults whose gender is different from their birth-assigned sex). Aim 3 (registered here) of the study is an open trial pilot study at a multi-clinic mental health agency, aimed at examining the feasibility and acceptability of conducting a future randomized controlled trial (RCT).


Virtual Implicit Bias Reduction and Neutralization Training (VIBRANT) 

Study Type: Interventional
Start Date: September 1, 2022
Eligibility: 11 Years to 99 Years, Accepts Healthy Volunteers
Location(s): University of Washington, Seattle, Washington, United States

Healthcare providers' implicit bias has been identified as a contributor to longstanding health inequities via negative impacts on the patient-clinician relationship and biased delivery of high-quality evidence-based practices (EBP). The implementation of any EBP runs the risk of worsening existing health disparities due to inequitable access, delivery, or benefit of the intervention. Clinician bias can be a critical and unaddressed determinant of implementation for any EBP. Although some implicit bias interventions for healthcare providers are emerging, studies have rarely included mental health professionals. In a previously NIMH funded project, our research team iteratively developed a brief (~45 minutes), interactive online Virtual Implicit Bias Reduction and Neutralization Training (VIBRANT) for school mental health clinicians with promising preliminary findings. The current study will test the effectiveness of VIBRANT-an implementation strategy for promoting equitable adoption, penetration, fidelity, and sustainment of EBPs. One highly learnable, efficient, and scalable EBP that is particularly well-suited for the education sector is Measurement-Base Care (MBC)-the systematic collection of patient-reported progress data to inform clinical decision-making. The proposed study aims to (1) evaluate VIBRANT's feasibility to promote equitable adoption, penetration, fidelity, and sustainment of MBC, with a validated, brief, interactive online training for MBC; (2) examine VIBRANT's impact on proximal mechanisms of change including clinicians' implicit bias as well as distal youth mental health outcomes (i.e., symptoms and functioning) with Black and Latinx youth, and (3) assess feasibility of research procedures for a future large-scale efficacy trial.


Electrophysiological Read-Out of Interoceptive Processing 

Study Type: Interventional
Start Date: August 10, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Mount Sinai West, New York, New York, United States

Interoception, or sensation from inside the body, is involved in a variety of clinical symptoms, such as tics, compulsions and negative mood. This study uses invasive recordings of brain activity and brain stimulation to better understand basic neural mechanisms of interoception and related behaviors. Outcomes of this study provide critical tools for future investigation into clinical symptoms that emerge from abnormal interoception.


Optimizing Implementation Coaching to Support Successful EBP Delivery 

Study Type: Interventional
Start Date: July 22, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): WA EBP Initiative, Seattle, Washington, United States

This project engages community mental health center (CMHC) clinical supervisors in the development and examination of an optimized coaching strategy for psychotherapists utilizing Cognitive Behavioral Therapy (CBT) in Washington State. The optimized coaching strategy has the potential to enhance the adoption and fidelity of evidence-based practice (EBP).


Reward Circuit Targeted iTBS 

Study Type: Interventional
Start Date: June 28, 2022
Eligibility: 18 Years to 55 Years, Accepts Healthy Volunteers
Location(s): FSU MRI Facility, Tallahassee, Florida, United States

The objective of this study is to examine the effect of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting the reward circuit.


How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD 

Study Type: Interventional
Start Date: June 15, 2022
Eligibility: 18 Years to 45 Years, Does Not Accept Healthy Volunteers
Location(s): University of Pennsylvania, Philadelphia, Pennsylvania, United States

Studies show that hormones affect the brain's fear extinction network, which is relevant for therapy involving exposure and response prevention (EX/RP), a first-line treatment for obsessive compulsive disorder (OCD). This study will examine the effect of delivering EX/RP to women during different phases in their menstrual cycle to determine the effects of hormones on the fear extinction network and on their OCD symptoms.


Estrogen Variability and Irritability During the Menopause Transition 

Study Type: Interventional
Start Date: June 15, 2022
Eligibility: Females, 45 Years to 59 Years, Accepts Healthy Volunteers
Location(s): Carolina Crossing B, Suite 1, Chapel Hill, North Carolina, United States

Women in the menopause transition (perimenopause) experience substantial day-to-day variability in estradiol and have a 2-4-fold increase in major depression risk. About 40% of perimenopausal women are susceptible to the emergence of affective symptoms tied to changes in estradiol. Among the perimenopausal women with affective impairment, most report irritability, not "depression," is their primary source of impairment and distress. The purpose of this research is to determine the neurophysiologic basis of susceptibility to estradiol fluctuations and irritability symptoms in perimenopausal women.


Suubi4StrongerFamilies 

Study Type: Interventional
Start Date: June 14, 2022
Eligibility: 10 Years to 14 Years, Does Not Accept Healthy Volunteers
Location(s): International Center for Child Health and Development, Masaka, Uganda

The study will examine the mechanisms by which Economic Empowerment (EE) and Family Strengthening (FS) interventions targeting social, familial and context-specific drivers affect childhood behavioral health (CBH). The study will randomly assign 900 children in mid-upper primary school (10 to 14 years) to one of the three study arms (10 schools each): 1) EE only (n=300), 2) Multiple Family Group (MFG)-based FS only (n=300), and 3) combined EE+MFG-based FS (n=300). The interventions will be provided for 12 months. Assessments will occur at baseline, 12, 24 and 36 months.


AMP SCZ® Observational Study: PREDICT-DPACC 

Study Type: Observational
Start Date: June 2, 2022
Eligibility: 12 Years to 30 Years, Accepts Healthy Volunteers
Location(s): Yale University/Connecticut Mental Health Center, New Haven, Connecticut, United States; University of Pavia, Pavia, Italy; The University of Hong Kong, Department of Psychiatry, Hong Kong, Hong Kong; Ludwig-Maximilians-Universität Munich, Munich, Germany; Copenhagen Research Center for Mental Health (CORE), Copenhagen, Denmark; Shanghai Jiao Tong University, Shanghai, China; McGill University, Montréal, Quebec, Canada; University of Calgary, Calgary, Alberta, Canada; Headspace, Werribee, Werribee, Victoria, Australia; Headspace, Sunshine, Sunshine, Victoria, Australia; Orygen Specialist Programs, Melbourne, Parkville, Victoria, Australia; Headspace Melton, Melton South, Victoria, Australia; Headspace, Glenroy, Glenroy, Victoria, Australia; Headspace, Craigieburn, Craigieburn, Victoria, Australia; HEP and co-located Headspace Adelaide, Adelaide, South Australia, Australia; University of Pittsburgh, Pittsburgh, Pennsylvania, United States; Temple University, Philadelphia, Pennsylvania, United States; University of Pennsylvania, Philadelphia, Pennsylvania, United States; University of Oregon, Eugene, Oregon, United States; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States; Northwell Health, Queens, New York, United States; Icahn School of Medicine at Mount Sinai, New York, New York, United States; Washington University, Saint Louis, Missouri, United States; Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States; Northwestern University, Evanston, Illinois, United States; University of Georgia, Athens, Georgia, United States; Hartford Healthcare, Hartford, Connecticut, United States; University of California San Francisco, San Francisco, California, United States; University of California San Diego, San Diego, California, United States; University of California Los Angeles, Los Angeles, California, United States; University of California Irvine, Irvine, California, United States; King's College London, London, United Kingdom; University of Cambridge, Cambridge, United Kingdom; Forward Thinking Birmingham, Birmingham, United Kingdom; Treatment and Early Intervention in Psychosis Program (TIPP) & Center for Psychiatric Neuroscience (CNP), Department of Psychiatry, Lausanne University Hospital, Lausanne, Switzerland; Instituto de Psiquiatría y Salud Mental Hospital General Universitario Gregorio Marañón, Madrid, Spain; Early Psychosis Intervention Programme (EPIP) Clinic, Institute of Mental Health, Singapore, Singapore; Seoul National University College of Medicine, Seoul, Korea, Republic of; Department of Psychiatry, Chonnam National University Hospital & Mindlink, Gwangju, Korea, Republic of

The Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) is a large international collaboration to develop algorithms using a set of clinical and cognitive assessments, multi-modal biomarkers, and clinical endpoints that can be used to predict the trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the testing of pharmacological interventions for CHR individuals in need. The goal is to accurately predict which individuals are likely to remit, experience an acute psychotic episode, or have intermediate outcomes that feature persistent attenuated psychotic and/or mood symptoms along with functional impairment. The prediction algorithms will have the potential to serve as early indicators of treatment efficacy in CHR persons.

The AMP SCZ research program is made up of the Psychosis Risk Evaluation, Data Integration, and Computational Technologies - Data Processing, Analysis and Coordination Center (PREDICT-DPACC) and two clinical research networks, the Psychosis-Risk Outcomes Network (ProNET) and the Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT) networks. The two clinical research networks will recruit a large cohort of CHR young people aged 12-30 years (n=1,977) and healthy control (HC) participants (n=640) across 42 participating investigative sites from 13 countries. CHR participants will complete screening, baseline assessments and a battery of follow-up assessments across 18 - 24 months. HC participants will complete screening and baseline assessments and a subset (5 per site) will complete month 2, 12 and 24 visits.


Characterization of an Optically Pumped Magnetometer (OPM) Magnetoencephalography (MEG) Array 

Study Type: Interventional
Start Date: May 12, 2022
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Brain activity produces magnetic fields. These fields can be measured outside the head. Existing technology, called MEG, measures these fields. Researchers are testing a new type of magnetic field sensor called OPM. They hope it can help pinpoint with very high accuracy where brain activity is generated.

Objective:

To develop and test a new type of sensor for measuring the magnetic fields produced by brain activity.

Eligibility:

Healthy people ages 18-65 who had a magnetic resonance imaging (MRI) scan under protocol 17-M-0181.

Design:

Participants may be asked to complete sessions on both the traditional MEG instrument and the OPM array.

For the MEG, 3 small coils will be placed on the participant s face with tape. Their head will be positioned inside the MEG device.

For the OPM, sensors are housed in a 3d printed array. The sensors will be attached to a cap placed on the participant s head.

For both scans, participants will be seated in a chair inside a magnetically shielded room. They may complete several tasks. In one task, plastic cells will be placed on their fingers. Puffs of air will be sent to these cells, which will stimulate the sense of touch. Other tasks may include the following stimuli: visual (such as checkerboards), auditory (such as beeps and tones), or language (words and letters).

Researchers may also obtain recordings while they stimulate the nerve in the participant s forearm using electrical current in small electrodes.

Participation is expected to last for 1 day. Additional optional scans may be offered for up to 1 year....


Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders 

Study Type: Interventional
Start Date: April 22, 2022
Eligibility: Females, 18 Years to 40 Years, Does Not Accept Healthy Volunteers
Location(s): Ohio University, Athens, Ohio, United States

The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.


Modulation of Emotion Perception in Humans Via Amygdala Stimulation 

Study Type: Interventional
Start Date: March 31, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

This study will enroll patients with epilepsy who are being evaluated for epilepsy surgery and have intracranial EEG electrodes. In this study, the aim is to record brain signals from areas important in social and emotional processing and to understand how electrical brain stimulation - called neuromodulation - affects such processing. Patients enrolled in this study will be asked to view images depicting a variety of emotionally positive, negative, or neutral themes. As the patient views these images, a small amount of imperceptible and painless electric current will be used to map function of certain parts of a human brain. The overarching goal of the study is to determine if neuromodulation can be used in certain areas of the brain to treat cognitive disorders such as memory loss and post-traumatic stress disorder.


Systems Analysis and Improvement Approach to Optimize the Task-shared Mental Health Treatment Cascade (SAIA-MH) 

Study Type: Interventional
Start Date: March 14, 2022
Eligibility: Age N/A, Does Not Accept Healthy Volunteers
Location(s): Urban Health Center Mascarenhas, Beira, Sofala, Mozambique; District Hospital Manica, Manica, Mozambique; Rural Hospital Nhamatanda, Nhamatanda, Sofala, Mozambique; Urban Health Center Dondo Sede, Dondo, Sofala, Mozambique; Rural Health Center Mafambisse, Dondo, Sofala, Mozambique; Hospital Muxúngue, Chibabava, Sofala, Mozambique; Urban Health Center Macurungo, Beira, Sofala, Mozambique; Urban Health Center Inhamizua, Beira, Sofala, Mozambique; Urban Health Center Chingussura, Beira, Sofala, Mozambique; Rural Health Center Vanduzi, Vanduzi, Manica, Mozambique; Rural Health Center Sussundenga Sede, Sussundenga, Manica, Mozambique; Rural Health Center Macate, Macate, Manica, Mozambique; District Hospital Gondola, Gondola, Manica, Mozambique; Urban Health Center Vila Nova, Chimoio, Manica, Mozambique; Urban Health Center Nhamaonha, Chimoio, Manica, Mozambique; District Hospital Catandica, Catandica, Manica, Mozambique

The purpose of this study is to test the effectiveness of a multicomponent implementation strategy entitled the Systems Analysis and Improvement Approach for mental health (SAIA-M) using a cluster randomized trial at the health facility level. SAIA-MH focuses on improving the mental health treatment cascade in primary outpatient mental healthcare. The mental health treatment cascade is a model that outlines the sequential, linked treatment steps that people with mental illness must navigate, from initial diagnosis to symptom/function improvement.

This study will also assess the potential mechanisms by which the SAIA-MH implementation strategy works, or does not work, along with the cost and effectiveness of scaling-up SAIA-MH in Mozambique.


Supporting Treatment Access and Recovery in COD 

Study Type: Interventional
Start Date: March 11, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Behavioral Health Network, Orange, Massachusetts, United States; SaVida Health, Worcester, Massachusetts, United States; UMass Chan Road to Care Clinic, Worcester, Massachusetts, United States; Behavioral Health Network, Springfield, Massachusetts, United States; Behavioral Health Network, Holyoke, Massachusetts, United States

This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.


Examining the Impact of Family Connectors 

Study Type: Interventional
Start Date: March 7, 2022
Eligibility: 18 Years to 85 Years, Accepts Healthy Volunteers
Location(s): NYU Langone Health, New York, New York, United States

The purpose of this study is to understand the impact of Family Connectors, a peer-to-peer support and education program for family members who have participated in OnTrackNY, a treatment program for adolescents and young adults.


Optimizing Engagement in Services for First-Episode Psychosis 

Study Type: Interventional
Start Date: March 1, 2022
Eligibility: 15 Years to 35 Years, Does Not Accept Healthy Volunteers
Location(s): San Fernando Mental Health Center, Granada Hills, California, United States; Olive View - UCLA Medical Center, Sylmar, California, United States

This study will compare a 12-session behavioral activation (BA) intervention modified for first-episode psychosis (FEP) to usual community mental health care (i.e., treatment-as-usual; TAU) delivered over 6 months with a sample of Latinos with FEP and their families. Comparable family group sessions will also be delivered to participants in both conditions. It is expected that BA participants will show better engagement than TAU participants.


Implementation of Adverse Childhood Experiences (ACEs) Policy 

Study Type: Interventional
Start Date: February 21, 2022
Eligibility: 0 Years to 5 Years, Accepts Healthy Volunteers
Location(s): Borrego Health, Desert Hot Springs, California, United States

Adverse Childhood Experiences (ACEs) are pervasive among children with 45% experiencing at least one ACE and 10% experiencing three or more, placing them at high risk for toxic stress and symptomatology. Yet, ACEs often go undetected in primary care settings during well-child visits due to unclear policies and tested implementation strategies. This pilot study will use mapping methodology, guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) framework, to refine a multi-faceted strategy supporting the implementation of the state of California's 2020 policy promoting universal ACE screening in community clinics, and a stepped-wedge trial to test the impact of the strategy on implementation and child-level outcomes.


An Ethical Approach to Detecting Covert Consciousness 

Study Type: Observational
Start Date: February 1, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Massachusetts General Hospital, Boston, Massachusetts, United States

This study aims to develop an ethical approach to developing and deploying novel neurotechnologies to aid in the detection of consciousness and prediction of recovery after brain injury.


Theta Connectivity in Working Memory 

Study Type: Interventional
Start Date: January 24, 2022
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

The participants will perform a cognitive control task. During the task, rhythmic trains of transcranial magnetic stimulation will be delivered to the prefrontal cortex and parietal cortex. Participants will be screened for their ability to perform the task. Magnetic resonance imaging will be used to localize regions of interest to be targeted. Electroencephalography will be collected concurrent with stimulation.


Prevention and Early Identification for High Risk Youth in School-based Clinics 

Study Type: Interventional
Start Date: January 3, 2022
Eligibility: 12 Years to 24 Years, Accepts Healthy Volunteers
Location(s): CHA Teen Health Center at Everett High School, Everett, Massachusetts, United States; CHA Health Equity Research Lab, Cambridge, Massachusetts, United States; Community, Cambridge, Massachusetts, United States; CHA-Teen Health Center at Cambridge Rindge and Latin School, Cambridge, Massachusetts, United States

The proposed research project provides a novel approach to screening, early assessment, and preventive interventions for high-risk youth in racial/ethnic/linguistically (REL)-diverse communities.

The investigators assess a health promotion intervention as a way of reducing treatment disparities in REL-minority youth. This population is underrepresented in child psychiatry research. It is often excluded from clinical trials of medication or therapy because of challenges with transportation, literacy, resources, or other issues. The study will take place during or following a healthcare crisis and economic recession, making findings relevant to understanding the mechanisms by which hardship translates into youth mental illness. The innovative integration of online screening into school-based clinics and community-based settings in REL-minority communities is made possible by the combination of access to a new technology (CAT) in the context of a learning health community serving a REL-minority population. Empirical research on the impact of a resilience-based prevention intervention in youth and youth at risk is both innovative and much needed during this period of health, social and economic crisis.


A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx 

Study Type: Interventional
Start Date: December 17, 2021
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): PRIME, Bronx, New York, United States

For caregivers in the Bronx, the pandemic has caused unprecedented psychological distress; in addition to combating social determinants of health (SDOH), these families now face greater financial insecurity and challenges related to their school-aged children. Furthermore, social distancing requirements and limited telehealth resources for Bronx families have posed greater barriers to healthcare. Such parental distress contributes to heightened risk of transgenerational cycles of psychological stress, trauma and maltreatment. The social and economic impacts of the COVID-19 pandemic have had significant consequences for family well-being, putting parents at higher risk of experiencing distress and potentially impairing their ability to provide supportive care to their children. Although children may be less susceptible to the most damaging physical consequences of COVID-19, there are growing concerns regarding the short-and long-term impacts of pandemic-related stressors on children. The marked upheaval of family life over an extended period may make children vulnerable to mental health consequences associated with the public health crisis and infection mitigation efforts. School and childcare closures, unstable financial circumstances, social isolation and lack of support have a disproportionate, cumulative impact on parents and may undermine their capacities to provide support for their children. Importantly, a large body of evidence suggests that parental stress during times of disasters induces psychopathologies in family members including children. Further, high anxiety and depressive symptoms in parents during the pandemic have been associated with higher child abuse potential, whereas greater parental support was associated with lower perceived stress and child abuse potential. In addition to psychological impacts, stress associated with caregiving can interfere with parents' ability to maintain their own health. This multimodal study addresses key strategies to mitigate the psychological and health impact of COVID-19 in parents.


Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations 

Study Type: Observational
Start Date: November 9, 2021
Eligibility: 6 Months to 8 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

During the first few decades of life, the brain changes dramatically in shape and function. Sleep lets researchers measure these changes. Researchers want to create a database of sleep and neurodevelopmental data in a group of infants and children to learn more.

Objective:

To address a knowledge and data gap in the field of sleep and neurodevelopment in infants and children.

Eligibility:

Children ages 6 months to 76 months who may or may not be at risk for neurodevelopmental and neuropsychiatric disorders. Also, children ages 6 months to 8 years who have a referral for a sleep study.

Design:

Participants will have neurodevelopmental testing. They will have a medical, psychiatric, and family history. They will have a physical and neurological exam. They will be interviewed and complete surveys. They will give a cheek swab and/or blood sample.

Some participants will have 1 study visit that lasts 2 days.

Other participants will have up to 4 study visits. Each visit will last 2 days. Visits occur every 8 months to 1 year, for a total participation time of 2 years.

Participants will have a 20-minute daytime electroencephalogram (EEG), if possible. This EEG session will be used to calibrate the machine for the overnight study.

Participants will take part in an inpatient overnight sleep study. Electrodes will be placed on the participants. For young children, parents will help place the EEG leads. Other sensors may also be placed. A gauze cap will be placed on participants head to protect the leads and keep the participants from moving them. 'Lights out' will occur as close to participants bedtime as possible.


Virtual Mom Power With High-Adversity Mothers and Children (MPHAMC) 

Study Type: Interventional
Start Date: November 1, 2021
Eligibility: 3 Years and Older, Accepts Healthy Volunteers
Location(s): Tulane Child and Family Lab, New Orleans, Louisiana, United States

This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily preventive intervention.


Enhancing Engagement With Digital Mental Health Care 

Study Type: Interventional
Start Date: October 15, 2021
Eligibility: Age N/A, Accepts Healthy Volunteers
Location(s): Groop Internet Platform DBA Talkspace, New York, New York, United States; Mental Health America, Alexandria, Virginia, United States

This proposal is a partnership between Mental Health America (MHA), a nonprofit mental health advocacy and resource organization, Talkspace (TS), a for-profit, online digital psychotherapy organization, and the University of Washington's Schools of Medicine and Computer Science Engineering (UW). The purpose of this partnership is to create a digital mental health research platform leveraging MHA and TS's marketing platforms and consumer base to describe the characteristics of optimal engagement with digital mental health treatment, and to identify effective, personalized methods to enhance motivation to engage in digital mental health treatment in order to improve mental health outcomes. These aims will be met by identifying and following at least 100,000 MHA and TS consumers over the next 4 years, apply machine learning approaches to characterizing client engagement subtypes, and apply micro-randomized trials to study the effectiveness of motivational enhancement strategies and response to digital mental health treatment.


Multi-level Determinants of Implementation and Sustainment in the Education Sector 

Study Type: Interventional
Start Date: October 13, 2021
Eligibility: 5 Years and Older, Accepts Healthy Volunteers
Location(s): Virginia Commonwealth University, Richmond, Virginia, United States; University of Florida, Gainesville, Florida, United States

The purpose of this study is to learn more about teachers' sustainment of use of core components of BEST in CLASS in a follow-up study.


EPI-MINN: Targeting Cognition and Motivation 

Study Type: Interventional
Start Date: August 12, 2021
Eligibility: 15 Years to 40 Years, Does Not Accept Healthy Volunteers
Location(s): Hennepin Healthcare, Minneapolis, Minnesota, United States; University of Minnesota, Minneapolis, Minnesota, United States; Human Development Center, Duluth, Minnesota, United States

The purpose of this study is to perform a practice-based research project designed to assess whether cognition and motivated behavior in early psychosis can be addressed as key treatment goals within real-world settings by using a 12-week mobile intervention program. Participants who are enrolled in a chart review study of measurement-based care will be recruited to participate in this study. In the measurement-based care study, participants are enrolled in coordinated specialty care programs for early psychosis that provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, work or education support, and measurement-based care. Participants will complete a set of well-defined measures every 6 months that assess symptoms, functioning, cognition and motivation as standard of care. The current study will utilize the data acquired in the measurement-based care study.

The aim of this study is to investigate a well-defined 12-week mobile intervention program specifically designed to target cognitive functioning and motivated behavior for individuals with early psychosis. The investigators will test for differences in the clinical trajectories over 18 months in those who receive the intervention vs. those who do not.

This study will be conducted jointly with a sister protocol under a separate NCT listing. This iteration will be conducted locally within the EPI-MINN Network, while the other project will be conducted on a national scale.


11C-YJH08 PET Imaging for the Detection of Glucocorticoid Receptor Expression in Patients With Metastatic Prostate Cancer 

Study Type: Interventional
Start Date: August 10, 2021
Eligibility: Males, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of California San Francisco, San Francisco, California, United States

This phase I trial studies if positron emission tomography (PET) imaging using 11C-YJH08 can be useful for detecting certain cell receptor expression in tumor cells in patients with prostate cancer that has spread to other parts of the body (metastatic). 11C-YJH08 is a small-molecule radiotracer that binds to receptors on cells (glucocorticoid receptor) so that they show up better on the PET scan. Anti-hormone therapy (including enzalutamide) can cause more glucocorticoid receptors to be produced in tumor cells, which can make the tumor cells resist hormone therapies. If researchers can find a better way to detect whether glucocorticoid receptors are increasing during therapy, it may lead to more successful therapies using glucocorticoid receptor antagonists.


Toward a Computationally-Informed, Personalized Treatment for Hallucinations 

Study Type: Interventional
Start Date: July 15, 2021
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Connecticut Mental Health Center, New Haven, Connecticut, United States

Auditory hallucinations are among the most distressing aspects of psychotic illness, and between 10 and 30% of people with hallucinations do not respond to antipsychotic medications. The authors have used computational modeling of behavior to link brain activity to development of auditory hallucinations in the hope of guiding new treatment development. The proposed studies take the first step toward individualized treatment approaches to hallucinations by attempting causal, pharmacological manipulation of relevant model parameters underlying these phenomena.


A Mightier Healthcare System 

Study Type: Interventional
Start Date: March 10, 2021
Eligibility: 8 Years to 12 Years, Does Not Accept Healthy Volunteers
Location(s): Neuromotion Inc, Boston, Massachusetts, United States

Access to effective pediatric mental health treatment is a major public health concern in the United States as paucity of pediatric providers leading to long wait times, financial burden, and stigma pose significant barriers to treatment. Digital mental health promises to remedy many chronic problems faced in providing timely and accessible mental health interventions to children. With that in mind, the investigators and Neuromotion Inc. created Mightier, an app-based heart rate biofeedback videogame platform designed to teach and facilitate practice of emotional regulation skills. The technology behind Mightier is backed by three trials showing clinical efficacy and since commercial launch 75% of families who have engaged with the product report improvement. However, Neuromotion's core mission remains increasing access to care, and the direct-to-consumer distribution of digital health also faces access challenges. The investigators propose that access to effective digital mental health interventions can be increased by meeting families where they already know to seek care: the traditional healthcare system. The investigators have partnered with a nationwide behavioral health insurance provider to pilot the integration of Mightier with traditional healthcare. Families will be recruited via direct outreach, social media, or healthcare provider referral. Participating children will be randomized into Mightier or treatment as usual control groups for 6 months. Behavioral healthcare utilization will be observed for 12 months. Through this work the investigators will demonstrate the value of Mightier to various stakeholders via decreased long-term healthcare utilization, confirm that Mightier use results in decreased symptoms of emotional dysregulation, irritability, and parent stress, and explore relationships among Mightier use, healthcare utilization, and symptoms. Ultimately this work will pave the way forward for large scale integration of digital healthcare and more traditional healthcare avenues while simultaneously increasing Mightier's ability to reach children in need.


Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis 

Study Type: Interventional
Start Date: January 1, 2021
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): New Journeys: Coordinated specialty care, Yakima, Washington, United States

Investigators aim to develop and evaluate a culturally informed family motivational engagement strategy (FAMES) and implementation toolkit for coordinated specialty care (CSC) programs for first episode psychosis. First, 5 family member participants will be recruited into a three-month trial of FAMES and implementation toolkit. The investigators will then conduct a 16-month non-randomized, stepped-wedge trial with 50 family members from 5 CSC programs in community-based mental health clinics.


Perceptual Abnormalities and Their Malleability in BDD 

Study Type: Interventional
Start Date: December 1, 2020
Eligibility: 18 Years to 40 Years, Accepts Healthy Volunteers
Location(s): Centre for Addiction and Mental Health, Toronto, Ontario, Canada

A core symptom of body dysmorphic disorder (BDD) is perceptual distortions for appearance, which contributes to poor insight and delusionality, limits engagement in treatment, and puts individuals at risk for relapse. Results from this study will provide a comprehensive mechanistic model of brain, behavioral, and emotional contributors to abnormal perceptual processing, as well as how malleable it is with visual modulation techniques. This will lay the groundwork for next-step translational perceptual retraining approaches.


Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID 

Study Type: Interventional
Start Date: December 1, 2020
Eligibility: 6 Years to 12 Years, Does Not Accept Healthy Volunteers
Location(s): Stanford University, Stanford, California, United States

This study is examining the efficacy and mechanism of family therapy compared to usual care for children between the ages of 6 and 12 who are diagnosed with Avoidant/Restrictive Food Intake Disorder. Preliminary data suggest that family therapy is superior to usual care and that improvement in parental self-efficacy related to feeding their children is the mechanism of treatment. In addition, this study will attempt to identify specific patient groups who respond to family therapy.


Artificial Intelligence to Measure Adherence to Oral Medication 

Study Type: Interventional
Start Date: November 20, 2020
Eligibility: 15 Years to 40 Years, Does Not Accept Healthy Volunteers
Location(s): Family and Children's Services, Tulsa, Oklahoma, United States; Red Rock, Oklahoma City, Oklahoma, United States; InterAct of Michigan, Kalamazoo, Michigan, United States; InterAct, Grand Rapids, Michigan, United States; Citrus Health, Hialeah, Florida, United States

The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients with first episode psychosis.


Non-Invasive Brain Stimulation to Control Large-Scale Brain Networks 

Study Type: Interventional
Start Date: November 1, 2020
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Minnesota, Minneapolis, Minnesota, United States

This project will assess the feasibility of traveling wave transcranial alternating current stimulation (tACS) to modify working memory performance and large-scale brain connectivity in surgical epilepsy patients.


Foster Care Mental Health Family Navigator 

Study Type: Interventional
Start Date: August 20, 2020
Eligibility: 12 Years to 17 Years, Does Not Accept Healthy Volunteers
Location(s): UCSF Zuckerberg San Francisco General Hospital, San Francisco, California, United States

This study will focus on developing and testing a family-based mental health navigator intervention, the Foster Care Family Navigator (FCFN), to evaluate whether the intervention combined with mHealth would be efficacious in improving mental health service initiation and engagement for child welfare-involved youth.


Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs 

Study Type: Interventional
Start Date: July 1, 2020
Eligibility: 15 Years to 40 Years, Accepts Healthy Volunteers
Location(s): InterAct of Michigan, Kalamazoo, Michigan, United States; Henderson Behavioral Health, Lauderdale Lakes, Florida, United States; InterAct of Michigan, Grand Rapids, Michigan, United States

Maintaining treatment engagement is critical for first episode psychosis patients to experience gains possible with coordinated specialty care (CSC). This study is designed to identify CSC participants still receiving care but at high risk for disengagement and to intervene to prevent/delay disengagement.


Neural Biomarkers of Electroconvulsive Therapy Response 

Study Type: Interventional
Start Date: April 1, 2020
Eligibility: 18 Years to 80 Years, Does Not Accept Healthy Volunteers
Location(s): The Zucker Hillside Hospital, Glen Oaks, New York, United States

In the proposed study, the investigators will utilize resting-state functional MRI (fMRI) and structural MRI-based electrical field modeling to study the effect of electroconvulsive therapy on human neural circuitry. Our study will recruit patients who are beginning treatment with bilateral electroconvulsive therapy (N=75). Our design will be longitudinal where patients will be followed up until their 8th week electroconvulsive therapy clinically. The primary measure of interest will be the slope of clinical change estimated with mixed effect modeling (see Approach). Secondary measures will be the cognitive performance change between baseline and the 8th week electroconvulsive therapy time point.


Navigation and Parent Peer Support to Promote Access 

Study Type: Interventional
Start Date: February 18, 2020
Eligibility: 1 Year to 99 Years, Accepts Healthy Volunteers
Location(s): University of Colorado School of Medicine, Aurora, Colorado, United States; Allegheny Family Network, Pittsburgh, Pennsylvania, United States; Uplift Wyoming, Cheyenne, Wyoming, United States

Nearly one in five children in the United States has a mental health problem that interferes with daily functioning and requires intervention, and yet less than 50% of children who need mental health care receive any services. Families and especially from low-income and ethnically diverse backgrounds, experience a range of barriers to engaging in services for their children including: lack of recognition of problems and knowledge of available treatments, connecting to services, trust in providers, stigma; low income and ethnically diverse populations are especially affected by these barriers. In this work, the investigators propose to carry out initial testing of a research- and theory-based model of Parent Peer Navigation services to help engage families with children with significant but pre-clinical problems in mental health services in order to prevent future poorer outcomes for children, who otherwise may never receive services, or only receive services when their mental health issues become severely debilitating for themselves and their family.


OnTrackNY's Learning Healthcare System 

Study Type: Observational
Start Date: August 15, 2019
Eligibility: 16 Years and Older
Location(s): OnTrackNY Central, New York, New York, United States

This application proposes OnTrackNY as a regional scientific hub for the Early Psychosis Intervention Network (EPINET) program as part of the National Institute of Mental Health (NIMH)'s creation of a national learning health care system (LHS) for early psychosis care. OnTrackNY has grown into a 22-site network, under the leadership of Lisa Dixon, MD, MPH.

Created and supported by the New York State's Office of Mental Health (OMH), OnTrackNY is a nationally recognized model providing coordinated specialty care (CSC) for adolescents and young adults within two years of the onset of non-affective psychosis. OMH regulates and licenses all mental health programs in New York and is a direct-services provider via state-operated programs statewide. This makes OMH an ideal partner for establishing a statewide learning health care system for early psychosis care. Further, OnTrackNY's administration, OnTrackCentral, operates within the OMH-supported Center for Practice Innovations at Columbia Psychiatry. In this model, OnTrackCentral serves as the hub and the 22 OnTrackNY programs serve as the spokes. Since 2014, the still-growing OnTrackNY network has served over 1,600 individuals. From its inception, OnTrackNY has aimed to deliver high-quality, data-driven, accountable and culturally competent care consistent with an LHS. As a condition of funding, all OnTrackNY providers follow established protocols that require submission of patient- and site-level standard measures of early psychosis clinical features, services, and treatment outcomes.

The proposed EPINET regional hub, the OnTrackNY LHS, will emphasize and enhance two critical foundational components - Aim 1: proactively engage stakeholders to optimize understanding of key problems and their solutions at every LHS phase; and Aim 2: develop data systems with enhanced standardized data collection, including post-discharge data and linkages to external data systems, and enhancing data analytics that will allow for client-level treatment planning and prospective analytics, delivering real time, dynamic and actionable information to stakeholders. These LHS components do not follow in a stepwise sequence but instead operate in parallel and interact to facilitate and enhance quality improvement processes. This backbone will support the development of practice-based research.


Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis 

Study Type: Interventional
Start Date: June 14, 2019
Eligibility: 18 Years to 99 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Inflammation can play a role in diseases like heart disease and rheumatoid arthritis. PET scans can help detect inflammation. Two new drugs may create better PET images.

Objective:

To see if the drugs [11C]ER176 and [11C]MC1 can help image inflammation.

Eligibility:

People ages 18 and older with rheumatoid arthritis or idiopathic inflammatory myopathy (IIM).

Healthy volunteers enrolled in protocol 01-M-0254 or 17-M-0181 are also needed.

Design:

Healthy participants will be screened under protocol 01-M-0254 or 17-M-0181.

Participants with arthritis or IIM will have a screening visit. This will include:

Medical history

Physical exam

Blood and urine tests

Possible CT or X-ray: A machine will take pictures of the body.

Healthy participants will have 1 or 2 visits. They may have urine tests. They may take the drug celecoxib by mouth. They will have a PET scan. A small amount of one or both study drugs will be injected through a catheter: A needle will guide a thin plastic tube into an arm vein. Another catheter will draw blood. They will like on a bed that slides into a machine. Their vital signs and heart activity will be measured.

Participants with arthritis will have up to 2 visits after screening. They may take celecoxib and have PET scans.

Participants with IIM will have up to 3 visits after screening. At 1 or 2 visits, they will take celecoxib and have PET scans. They will have 1 visit where they have an MRI: They will lie on a table that slides into a machine. The machine takes pictures of the body.


Maximizing the Impact of Neuroplasticity Using Transcranial Electrical Stimulation Study 1 

Study Type: Interventional
Start Date: April 1, 2019
Eligibility: 18 Years to 60 Years, Accepts Healthy Volunteers
Location(s): University of Minnesota, Minneapolis, Minnesota, United States

Non-invasive neuromodulation, such as transcranial direct current stimulation ( tDCS) , is emerging as an important therapeutic tool with documented effects on brain circuitry, yet little is understood about h ow it changes cognition. In particular, tDCS may have a critical role to play in generalization, that is how training in one domain generalizes to unlearned or unpracticed domains. This problem has resonance for disorders with cognitive deficits, such as schizophrenia.

Understanding how tDCS affects brain circuity is critical to the design and application of effective interventions, especially if the effects are different for healthy vs. psychiatric populations. In previous research, one clue to the mechanism underlying increased learning and generalization with tDCS was provided by neuroimaging data from subjects with schizophrenia undergoing cognitive training where increases in thalamocortical (prefrontal) functional connectivity (FC) predicted greater generalization.

The premise of this proposal is that increases in thalamocortical FC are associated with the generalization of cognitive training, and tDCS facilitates these increases. The overarching goals of this proposal are to deploy neuroimaging and cognitive testing to understand how tDCS with cognitive training affect thalamocortical circuitry in individuals with and without psychosis and to examine variability in response within both groups.

Study 1 will compare right prefrontal, left prefrontal and sham tDCS during concurrent cognitive training over 12 weeks in 90 healthy controls. Study 2 will be similar in all aspects but will examine 90 patients with schizophrenia or schizoaffective disorder and include clinical assessments. Results of the study will provide crucial information about location of stimulation, length of treatment, modeled dosage, trajectory and durability needed to guide future research and interventions for cognitive impairments.


Unobtrusive Sensing of Medication Intake ("USE-MI") 

Study Type: Interventional
Start Date: January 8, 2019
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Swedish Medical Center, Seattle, Washington, United States

The purpose of this study is to test the USE-MI system hardware and software to see if it can accurately measure when subjects take their HIV-related medications and help them remember to take these medications. With the use of a smartwatch and smartphone "app", investigators hope to be able to monitor medication adherence in real-time and send subjects electronic reminders when they may have forgotten to take their medication.


Behavioral and Neural Representations of Subjective Effort Cost 

Study Type: Interventional
Start Date: August 1, 2018
Eligibility: 18 Years to 35 Years, Accepts Healthy Volunteers
Location(s): Kennedy Krieger Institute, Baltimore, Maryland, United States

The goal of this proposal is to understand the common and distinct behavioral and neural representations of subjective effort valuation, and how these representations are influenced by fatigue and changes in motivation. It is hypothesized that the brain will use overlapping and distinct neural circuits to represent cognitive and physical effort value, and that fatigue and enhanced motivation will influence the subjective value of effort.


Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging 

Study Type: Interventional
Start Date: July 12, 2018
Eligibility: 7 Years to 100 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Magnetic resonance imaging (MRI) is an important non-invasive tool to study and diagnose cardiovascular disease. MRI scanners use strong magnetic fields and radio waves to create pictures of body organs. Researchers want to find better MRI methods and new ways of imaging cardiovascular disease and better understand normal and abnormal cardiovascular and brain function. Researchers are also interested in seeing if gadolinium, the commonly used MRI contrast agent, stays in the body long after the MRI was performed.

Objectives:

To develop new methods for imaging the heart and other organs of the body.

To describe cardiovascular diseases using newer MRI methods

To look at the relationship between cardiovascular disease and cardiovascular risk factors and other organ systems

To look for gadolinium deposits in the brain from prior exams.

Eligibility:

Healthy people and people with known or suspected cardiovascular disease ages 7 and older may be eligible for this study.

Researchers may be particularly interested in those who:

Have suspected or known cardiovascular disease Were previously exposed to a gadolinium-based contrast agent, Need to have a heart MRI scheduled Need a test of the heart or other body part or will be undergoing a future cardiac catheterization

Design:

There are multiple arms to the study with optional components; therefore, there are multiple variations as to what an individual participant s experience may involve.

Participants will have an MRI scan lasting up to 2 hours. The scanner is a large hollow tube. During the scan, there may be loud knocking and buzzing sounds caused by the scanner. Participants will lie on a table that slides in and out of the tube. Their vital signs may be monitored.

Participants may have a test of heart electrical activity using wires connected to pads on the skin.

Participants may have blood drawn.

Participants may be injected with an MRI contrast agent through a plastic tube inserted in the arm.


Development of Non-Invasive Brain Stimulation Techniques 

Study Type: Interventional
Start Date: January 11, 2018
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Noninvasive brain stimulation (NIBS) may help diagnose and treat psychiatric and neurological illness. But there is not enough research on how to apply NIBS. This includes how strong to make it, where on the brain to apply it, and for how long. Researchers also want to see what the brain is doing when it receives NIBS.

Objective:

To increase the effectiveness of NIBS.

Eligibility:

Healthy native English speakers ages 18-65

Design:

Participants will be screened under another protocol with:

Medical and psychiatric history

Psychiatric evaluation

Physical exam

Urine tests

All participants will start with a 2-hour visit for screening. (see below). They may learn how to do tasks that will be used later. After the screening session, they will be scheduled for an MRI session.

The next part of the study is 4 substudies. Each substudy includes up to 4 sessions. A session is usually 2-3 hours but can last up to 8 hours. Participants can join multiple substudies, but only 1 at a time. They can do only 1 session on a given day.

Each substudy includes the following:

Behavioral tests: Interviews; questionnaires; simple tasks; and tests of memory, attention, and thinking

Electromyography: Small sticky electrodes on the skin measure muscle activity.

Transcranial magnetic stimulation: A wire coil is held to the scalp. A brief electrical current passes through the coil and affects brain activity.

Magnetic resonance imaging (MRI): Participants lie on a table that slides into a machine that takes pictures of the brain. A coil is placed over the head. They will perform simple tasks while in the scanner. They may also get TMS.

Electroencephalography: Small electrodes on the scalp record brain waves.

Sponsoring Institution: National Institute of M


NIAID Centralized Sequencing Protocol 

Study Type: Observational
Start Date: July 31, 2017
Eligibility: 1 Day and Older, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States; Children's National Health System, Washington, District of Columbia, United States

Background:

Genetic testing called "sequencing" helps researchers look at DNA. Genes are made of DNA and are the instructions for our bodies to function. We all have thousands of genes. DNA variants are differences in genes between two people. We all have lots of variants. Most are harmless and some cause differences like blue or brown eyes. A few variants can cause health problems.

Objective:

To understand the genetics of immune disorders various health conditions, as well as outcomes of clinical genomics and genetic counseling services performed under this protocol.

Eligibility:

Participants in other NIH human subjects research protocols - either at the NIH Clinical Center (CC) or at Children s National Health System (CNHS) - (aged 0-99 years), and, in select cases, their biological relatives

Design:

Researchers will study participant s DNA extracted from blood, saliva, or another tissue sample, including previously collected samples we may have stored at the NIH. Researchers will look at participant s DNA in great detail. We are looking for differences in the DNA sequence or structure between participants and other people.

Participants will receive results that:

Are important to their health Have been confirmed in a clinical lab Suggest that they could be at risk for serious disease that may affect your current or future medical management.

Some genetic information we return to participants may be of uncertain importance.

If genetic test results are unrelated to the participant s NIH evaluations, then we will not typically report:

Normal variants Information about progressive, fatal conditions that have no effective treatment Carrier status (conditions you don t have but could pass on)

The samples and data will be saved for future research.

Personal data will be kept as private as possible.

If future studies need new information, participants may be contacted.


Main Study: Influence on Plasticity of Brain Temperature Sub-Study: Phase Triggered Paired Associative Stimulation (PAS) 

Study Type: Interventional
Start Date: May 3, 2016
Eligibility: 18 Years to 35 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Sub-Study: Phase Triggered Paired Associative Stimulation (PAS) (actively recruiting)

Background:

-Previous research has shown that the brain s activity changes with changes in brain waves. We can study brain activity with a procedure called transcranial magnetic stimulation (TMS), a form of non-invasive brain stimulation. EEG allows for measuring ongoing brain waves. The goal of this study is to optimize TMS delivery by utilizing EEG-triggered TMS.

Objectives:

-To see if changes in brain waves change the brain and body s response to TMS.

Eligibility:

-Healthy, right-handed adults age 18-35.

Design:

Participants will be screened under another protocol with medical history and physical exam. They may take a pregnancy test. They will have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie on a table that slides in and out of a metal tube that takes pictures. with: Participants will have up to 4 outpatient visits lasting 2-3 hours each (4 outpatient visits). The following procedures may occur at a visit: Magnetic resonance imaging (MRI): Participants lie on a table that slides into a machine that takes pictures of the brain. Electroencephalography (EEG): Small electrodes on the scalp record brain waves. Electromyography (EMG): Small sticky electrodes on the skin measure muscle activity. Transcranial magnetic stimulation (TMS): A wire coil is held to the scalp. A brief electrical current passes through the coil and affects brain activity.

Main Study: Influence on Plasticity of Brain Temperature (no longer recruiting)

Background:

- Brain activity changes with changes in body temperature. Brain activity can be studied with a procedure called transcranial magnetic stimulation (TMS). Researchers want to cool the brain through the scalp using a cooling cap. They want to see if cooling changes the brain and body s response to TMS.

Objectives:

- To look at the effects of cooling on the brain.

Eligibility:

- Right-handed adults age 18-50 who can abstain from caffeine and tobacco.

Design:

Participants will be screened with medical history and physical exam. They will be asked about alcohol use, smoking, and substance abuse. They may take a pregnancy test. They may have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie on a table that slides in and out of a metal tube that takes pictures. Participants will have 3 outpatient visits. The following procedures will occur at each visit. Participants will wear a cooling cap for up to 45 minutes. Cool water will flow through the cap. It will feel like an ice pack in a towel. Their core temperature will be monitored. Their temperature will also be measured under their tongue and on scalp, stomach, forearm, and calf. Participants will have TMS before and after wearing the cap. A brief electrical current will pass through a wire coil held on their scalp. Electrodes that detect muscle movement will be placed on their hand. They will also have repetitive TMS, which uses repeated magnetic pulses. Their wrist will also receive a shock.


Psychological Treatments for Youth With Severe Irritability. 

Study Type: Observational
Start Date: November 17, 2015
Eligibility: 8 Years to 17 Years, Does Not Accept Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

When children have severe irritability and temper outbursts, they can be so cranky or angry that it leads to problems at home, in school, and with friends. This is called Disruptive Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed specifically for children with this problem. Researchers think two forms of therapy, Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help children with DMDD.

Objective:

To test two whether IBT and CBT can decrease severe irritability in children and youth.

Eligibility:

Children 8-17 years old with DMDD. Their symptoms must have started before age 10.

Design:

Participants will be screened with a review of their symptoms. Parents and participants will answer questions.

Participants can do only one or both of these treatments if they wish. Those who wish to do both will start with IBT.

Participants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent will participate in part of the sessions.

Participants will talk about what makes them irritable and how it affects them. They may be put in situations that might make them annoyed or irritable.

Participants will rate how intense their irritability is. Parents and participants will complete rating scales, questionnaires, and interviews.

Participants will do practice activities at home.

Participants doing IBT will have up to 14 sessions over 10 weeks.

Participants will view 15 faces, one at a time, on a computer. They will choose if the face looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will complete some sessions at the NIH and some at home.

Participants and parents answer questions about their progress.

...


Checking Out Checking In: The Development and Validation of an Electronic Screening Tool for Pediatric Psychosocial Distress 

Study Type: Observational
Start Date: April 14, 2015
Eligibility: 8 Years to 21 Years, Does Not Accept Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

- Medical problems and treatments can cause stress in some people. Researchers want to learn more about how to measure distress in young people with medical illnesses. A screening tool called Checking In will be developed in order to help researchers find ways to identify concerns and stresses common to this group.

Objective:

- To create a screening tool that will help health care providers identify psychological and social distress in young people with serious illnesses.

Eligibility:

- Outpatient youth ages 8 21 who are enrolled on a research protocol at the NIH at the time of the study.

Design:

Phase 1 participants will complete a paper-and-pencil version of Checking In. It asks about mood, pain, fatigue, peer relationships, and sleep. During this phase, participants will be asked about the wording of the questions in Checking In. They will also talk about what they thought of the questions and if they understood them. Phase 2 will not involve participant enrollment. During this phase the researchers will be working with technologists to develop the software for an electronic version of Checking In. Phase 3 participants will complete an electronic version of Checking In. Researchers will ask questions about the ease or difficulty of using an electronic screen. Phase 4 participants and one of their caregivers will complete an electronic version of Checking In. They will also complete other questionnaires related to mood, pain fatigue, peer relationships and sleep. They will be asked their thoughts about using Checking In. On the same day, their NIH doctor will get summary data about their questionnaire answers. The doctor will also provide feedback about the summary form. Researchers will compare data from Checking In with data from the other questionnaires.


Brain Stimulation and Vision Testing 

Study Type: Observational
Start Date: March 4, 2013
Eligibility: 18 Years to 50 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

-The brain has two systems for recognizing objects. One system recognizes what an object is, and the other system recognizes where the object is located. However, there is much about how the brain handles and interprets the information from these two systems that is still unclear. Researchers want to study the parts of the brain that are involved in how vision is processed. They will use magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS) or transcranial electrical stimulation (tES) on the brain. MRI measures what parts of the brain become more active when tasks are performed. TMS uses magnetic pulses to temporarily change the activity in parts of the brain. tES uses electrical current to temporarily change brain function.

Objectives:

-To better understand how people visually recognize different types of objects.

Eligibility:

-Healthy volunteers between 18 and 50 years of age, who only speak English.

Design:

This study includes many different experiments on vision. Each experiment may combine visual tasks, MRI scans, and TMS or tES. Participants may be asked to have several different tests. Each test will require a separate visit to the National Institutes of Health. Participants will be screened with a physical exam and medical history. They will have a baseline brain scan at the first visit. Participants may do visual tasks alone, with MRI only, with TMS or tES only, or with MRI and TMS or tES combined. For the visual tasks, they will look at pictures of objects on a computer screen. Sometimes the images will appear very briefly (less than one-tenth of a second). Sometimes they will appear for up to 5 seconds. These images will be of things like faces, bodies, tools, and scenes. Participants will be asked to respond in different ways to the pictures. They may respond by typing on a computer keyboard or by pressing a button. Participants will have time to practice the tasks before the experiment. Participants will remain on the study for up to 3 years.


Top-Down Attentional Control of Visual-Processing 

Study Type: Observational
Start Date: July 23, 2012
Eligibility: 18 Years to 100 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

- Previous studies have shown that people with certain types of brain damage may have particular problems paying attention and processing things that they see. Researchers are interested in comparing how people with brain damage and without brain damage process visual images.

Objectives:

- To better understand the areas of the brain involved in paying attention to things that are seen.

Eligibility:

- Individuals at least 18 years of age who either have had damage to one or both sides of specific parts of the brain (e.g., stroke, injury, certain neurosurgery procedures) or are healthy volunteers.

Design:

The study involves 4 to 10 visits to the NIH Clinical Center over 1 to 2 years. Each visit will last approximately 2 hours. Participants will be screened with a medical history and physical examination, and may have the cognitive testing described below during the same visit. On the first visit and for at least one visit thereafter, participants will have cognitive testing to evaluate thinking and memory. These tests will be either written tests or computer-based tests. Some participants will qualify for functional magnetic resonance imaging (fMRI) as part of the study. This part will involve a decision-making task that will be performed on a computer during the fMRI scan. Additional scans may be required as directed by the study doctors. Some randomly selected participants will be asked to have magnetoencephalography (MEG), a procedure to record very small magnetic field changes produced by brain activity. During the behavioral training, or fMRI or MEG scanning, participants may be monitored with equipment to track eye movements.


A Longitudinal Investigation of the Endocrine and Neurobiologic Events Accompanying Puberty 

Study Type: Observational
Start Date: November 23, 2011
Eligibility: 7 Years to 35 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Despite the clear importance of adolescence in the emergence of a number of disease states and processes, there is surprisingly little known about how the endocrine and metabolic events accompanying puberty in humans impact normal developmental neurobiology. Epidemiologic studies have identified sexual dimorphisms in the prevalence of several neuropsychiatric disorders, including depression, schizophrenia, and substance abuse. Many of these sex differences emerge during or shortly after puberty and are maintained until the 5th-6th decade of life. For example, the two-fold greater risk of unipolar depression in women compared with men does not appear until adolescence, and prior to puberty girls are not at increased risk relative to boys. Puberty is a structured, transitional process that can be influenced by both nutritional factors and environmental stressors; nonetheless, the variability in the timing and duration of puberty is largely determined by oligogenic inheritance. Basic neuroscience research has demonstrated that hormonal events accompanying puberty impact on many of the physiologic systems involved in the regulation of brain function (e.g., the appearance of new neurons in a brain-region specific pattern, neuronal remodeling, and the pruning of cortical connectivity). Additionally, not only does stress during puberty increase the risk of disturbances in affective adaptation during adulthood, but the events accompanying puberty modify stress responsivity (e.g., alterations in the duration and peak response of hypothalamic-pituitary-adrenal [HPA] axis hormones to stressors). Moreover, animal work has demonstrated that neural connectivity differs in a brain regional specific manner according to the stage of puberty (i.e., early versus late). In humans, puberty also occurs in stages, and although the endocrinology of puberty, surprisingly, has not been fully characterized with longitudinal data, studies have documented that the physical changes measured by Tanner stages I to V are accompanied by progressive increases in the secretions of both gonadal and adrenal steroids. Nonetheless, there remains considerable variability in the timing and duration of this otherwise highly structured reproductive transition.

We propose to perform a longitudinal, naturalistic study examining changes in brain structure and function, behavior, and stress responsivity in boys and girls across the pubertal transition. Because the pubertal transition is defined by a complex series of physiologic events that emerge sequentially over several years and involve changes in multiple endocrine and growth systems, and because there is also considerable variability in the timing of these events reflecting the influence of both genetic and environmental factors, puberty cannot by delineated by age of the participants as has been done in most imaging and other neurobiological studies of adolescence. The present study will formally bridge this gap by defining pubertal events per se in participants.

Participants will include healthy boys and girls whose pubertal status will be assessed, and in whom endocrine, metabolic, and brain imaging measures will be evaluated at eight - ten month intervals from age eight years (pre-puberty) until age 17 years (post-puberty). Reproductive endocrine, metabolic, and physical measures will be employed to characterize the stage and duration of pubertal development. Outcome measures will be derived via multimodal neuroimaging techniques, cognitive/behavioral assessments, metabolic measurements, and evaluations of HPA axis function. Additionally, the impact of genetic variation on the developmental trajectory of these parameters (both reproductive and CNS) will be determined.

This cross-institute proposal will employ a multidisciplinary approach to evaluating the effects on CNS function of the process of puberty in both boys and girls. This work will not only serve to inform research on the mechanisms by which sexual dimorphisms in neuropsychiatric disorders develop, it will also have important implications for the prevention and treatment of these disorders.


Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle 

Study Type: Interventional
Start Date: January 27, 2011
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

- Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of the human body and evaluate activity in the brain. A particular MRI method called magnetic resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help researchers who are studying new treatments for psychiatric illnesses. Researchers are interested in improving current MRI and MRS techniques, as well as developing new MRI and MRS techniques to view and measure brain chemicals and brain activity.

Objectives:

- To implement, develop, and optimize brain chemistry imaging techniques using magnetic resonance imaging and magnetic resonance spectroscopy.

Eligibility:

- Healthy individuals between 18 and 65 years of age.

Design:

This study will involve a screening visit and a scanning visit at the National Institutes of Health Clinical Center. Participants will be screened with a full medical and physical examination, blood and urine tests, and neurological testing. During the second visit, participants will have an MRI scan of the brain. (Participants who have received an MRI within the past year will not need to have a second one; the images of the previous scan will be used for this study.) All participants will then have an MRS scan using the same scanning equipment.


Defining the Brain Phenotype of Children With Williams Syndrome 

Study Type: Observational
Start Date: January 23, 2011
Eligibility: 5 Years and Older, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

- Little is known about how the brain changes during childhood and adolescence, how genes affect this process, or how the brains of people with 7q11.23 genetic variation change during this period. Researchers are interested in using magnetic resonance imaging to study how the brain changes in healthy children and children with 7q11.23 genetic variation, including Williams syndrome and 7q11.23 duplication syndrome.

Objectives:

- To study developmental changes in the brains of healthy children and children who have been diagnosed with Williams syndrome,7q11.23 duplication syndrome, or other 7q11.23 genetic variation.

Eligibility:

Healthy children and adolescents between 5 and 17 years of age. Children and adolescents between 5 and 17 years of age who have been diagnosed with Williams syndrome, 7q11.23 duplication syndrome, or have other 7q11.23 genetic variation.

Design:

Participants will have a brief physical examination and tests of memory, attention, concentration, and thinking. Parents will be asked about their child s personality, behavior characteristics, and social interaction and communication skills. Both participants and their parents may be asked to complete additional questionnaires or take various tests as required for the study. Participants will have approximately 10 hours of magnetic resonance imaging (MRI) scanning, usually over 4 to 5 days, within a one month period. Some of these tests will require the participants to do specific tasks while inside the MRI scanner. Participants will be asked to return to the National Institutes of Health clinical center to repeat these procedures every 2 years thereafter until age 18.


Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women 

Study Type: Observational
Start Date: March 31, 2007
Eligibility: Age N/A, Accepts Healthy Volunteers
Location(s): Tulane University Health Sciences Center, New Orleans, Louisiana, United States; Rutgers - New Jersey Medical School, Newark, New Jersey, United States; Bronx Lebanon Hospital Center, Bronx, New York, United States; SUNY Downstate Medical Center, Brooklyn, New York, United States; New York University School of Medicine, New York, New York, United States; St. Jude Children's Research Hospital, Memphis, Tennessee, United States; Baylor College of Medicine, Houston, Texas, United States; University of Puerto Rico Medical Center, San Juan, Puerto Rico; San Juan Research Hospital, San Juan, Puerto Rico; University of Alabama, Birmingham, Alabama, United States; University of California San Diego, La Jolla, California, United States; University of Southern California, Los Angeles, California, United States; University of Colorado Denver Health Sciences Center, Aurora, Colorado, United States; Children's Diagnostic & Treatment Center, Fort Lauderdale, Florida, United States; University of Florida Health Science Center, Jacksonville, Florida, United States; University of Miami, Miami, Florida, United States; University of Illinois, Chicago, Chicago, Illinois, United States; Ann and Robert H. Lurie Children's Hospital, Chicago, Illinois, United States

SMARTT will estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers.


MRS Measurement of Glutamate and GABA Metabolism in Brain 

Study Type: Interventional
Start Date: September 6, 2006
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

This study will use magnetic resonance spectroscopy (MRS) to measure in the brain the transfer of [13]C as it is naturally metabolized from glucose to specific chemical transmitters. From this method, we can measure the rate of production of an important excitatory neurotransmitter (glutamate) as well as an inhibitory neurotransmitter (GABA).


Studies of Blood Flow to the Brain During Thought 

Study Type: Observational
Start Date: September 17, 1993
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

The purpose of this study is to use brain imaging technology to measure changes in blood flow to areas in the brain as individuals perform intellectual tasks.

This study will use functional magnetic resonance imaging (fMRI) to examine blood flow to areas of the brain as participants engage in tasks associated with visual perception, visual recognition, and memory.