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Studies Recruiting Only Women

Mental disorders affect women and men differently — some disorders are more common in women or may be characterized by different symptoms in women and men. Learn more about women and mental health.

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Featured Studies

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


An HIV Status-neutral Microeconomic Intervention 

Study Type: Interventional
Start Date: June 7, 2024
Eligibility: Females, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Ruth Ellis Center, Highland Park, Michigan, United States

The aim is the current study is to establish feasibility and acceptability of the SeCuRE intervention to improve HIV prevention and care continua outcomes. To meet this aim, the study has the following objectives:

To deliver a two-armed pilot RCT of the SeCuRE intervention with 40 transgender women of color. The determine acceptability of the intervention with transgender women of color.


Suicide Prevention Integration Into Task-shifted Mental Health Interventions 

Study Type: Interventional
Start Date: May 13, 2024
Eligibility: Females, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Islamabad Capital Territory, Islamabad, Pakistan

Investigators will conduct a pilot clinical trial to assess the feasibility and acceptability of implementing a Suicide Prevention Package (SuPP) within an existing task-shifted depression intervention in rural Pakistan. This pilot research lays the groundwork for a future project to scale a package for multi-level suicide prevention strategies that can be integrated into community based mental health programs, particularly targeting individuals living in low-resourced settings. As the model is designed to be easily adapted and integrated, investigators anticipate the findings will be valuable for all researchers looking to improve population health and mental health services in disadvantaged settings.


Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa 

Study Type: Interventional
Start Date: April 16, 2024
Eligibility: Females, 16 Years and Older, Accepts Healthy Volunteers
Location(s): TB HIV Care, Pietermaritzburg, KwaZulu Natal, South Africa

The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South Africa. Participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use PrEP. The four strategies being tested are: case management, food vouchers, peer support buddies, and community-based PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use, so that these services can be scaled up to other districts in South Africa.


ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression 

Study Type: Interventional
Start Date: March 15, 2024
Eligibility: Females, 18 Years to 75 Years, Accepts Healthy Volunteers
Location(s): International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh

The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question[s] it aims to answer are: 1) whether adding poverty alleviation to depression treatment in an integrated intervention improves depression outcomes at 24 months, as assessed by depressive symptoms and by the presence or absence of relapse; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in interviews at 6,12,18 and 24 months.


Changes in Inhibition and Valuation After Eating 

Study Type: Interventional
Start Date: December 12, 2023
Eligibility: Females, 18 Years to 45 Years, Accepts Healthy Volunteers
Location(s): Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai, New York, New York, United States

An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this impairment may not represent a stable trait or be the most effective focus for treatment. This project aims to understand how predictions and value-based decisions about control may be abnormally influenced by eating in individuals with BN, thereby maintaining cycles of binge eating, purging, and restriction.


Response to Acute Exercise in Eating Disorders 

Study Type: Interventional
Start Date: November 2, 2023
Eligibility: Females, 16 Years to 22 Years, Accepts Healthy Volunteers
Location(s): University of Wisconsin-Madison, Madison, Wisconsin, United States; University of California San Francisco, San Francisco, California, United States

Individuals with eating disorders (ED) represent a high-priority clinical population, with among the highest mortality rates of any psychiatric disorder, and driven exercise (DEx) is a symptom evidenced in up to 80% of those with EDs that increases impairment and negatively impacts treatment outcome. This study will develop tasks to characterize cognitive, affective, and biological response to exercise among adolescent and young adult females with EDs and determine whether acute exercise response associates with free-living activity and DEx. This R21 project will provide foundational data to guide research and development of treatments that are more precisely targeted to the symptom of driven exercise and to ultimately improve clinical outcomes associated with EDs.


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 31929, Sizwe CRS, Johannesburg, South Africa; Site 31790, Desmond Tutu TB Centre (DTTC) CRS, Cape Town, South Africa; Site 31976, PHRU Matlosana CRS, Klerksdorp, North West Province, South Africa; Site 5115, Siriraj Hospital, Mahidol University NICHD CRS, Bangkok Noi, Thailand

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).


Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery 

Study Type: Interventional
Start Date: September 25, 2023
Eligibility: Females, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Magee Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States

The purpose of this study is to identify a tolerable dose for postpartum ketamine infusion using a maximum tolerated dose (MTD) 3+3 design. A loading dose over 1 hour will be the MTD variable to be tested, as our data suggest that ketamine side effects occur with the loading dose. The investigators hypothesize that subanesthetic ketamine dose will be well tolerated and any noted side effects will be rated acceptable by postpartum women following cesarean delivery.


Treatment of Post-partum Depression Using an Behavioral Intervention Called ROSE (Reach Out, Stay Strong, Essentials for Mothers of Newborns) Delivered Using an Electronic App 

Study Type: Interventional
Start Date: July 17, 2023
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Rochester Medical Center, Rochester, New York, United States

A randomized trial of pregnant people at risk for postpartum depression comparing the InBloom app (n = 76) to ROSE (n = 76; weekly scheduled group), and two control groups. We will assess Depression at baseline and 1, 2 and 3 months, ROI at 3 months, Satisfaction at 1 and 3 months and Perceived Access at 1 and 3 months. Subject participation will last up to 8 months (minimum 17 weeks pregnant through 3 months postpartum).


Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa 

Study Type: Interventional
Start Date: July 1, 2023
Eligibility: Females, 15 Years and Older, Accepts Healthy Volunteers
Location(s): Gugulethu Midwife Obstetric Unit (MOU), Cape Town, Western Cape, South Africa

Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV. However, posttraumatic stress (associated with intimate partner violence and/or other traumas) and depression negatively impact PrEP adherence among women in SA. Addressing posttraumatic stress and depression will likely improve PrEP adherence and persistence (i.e., sustained PrEP adherence over time) during pregnancy and breastfeeding, which are periods of dramatically increased HIV risk. The overarching goal of this proposal is to develop and test the feasibility and acceptability of a cognitive behavioral intervention that targets common underlying factors of posttraumatic stress and depression to improve PrEP adherence and persistence during pregnancy and the postpartum transition. The specific aims of the project are to (1) explore the mechanisms by which posttraumatic stress and depression impact PrEP adherence and persistence during pregnancy via qualitative interviews; (2) develop a brief PrEP adherence and persistence intervention (~4 sessions) that reduces the negative impact of psychological mechanisms common to posttraumatic stress and depression on PrEP use, and builds behavioral skills to improve self-care; and (3) evaluate the feasibility, acceptability, and signals of preliminary efficacy of the intervention, which will be integrated into antenatal care, in a pilot randomized controlled trial. All data will be collected in the Midwife Obstetrics Unit (MOU) in Gugulethu, a peri-urban settlement and former township community outside of Cape Town, SA.


Virtual Patient Navigation During a Pandemic 

Study Type: Interventional
Start Date: June 29, 2023
Eligibility: Females, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

The sub-study will involve a rigorous mixed-methods design. The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services. This information will be used to adapt an evidence-based patient navigation intervention for virtual use and an engagement measure. For the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.


1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV 

Study Type: Interventional
Start Date: June 26, 2023
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Johns Hopkins School of Nursing, Baltimore, Maryland, United States

This study tests a 5-session cognitive behavioral approach program (herein referred to as the 1MoreStep intervention) to train Black women living with HIV (LWH) and exposed to intimate partner violence (IPV) in the past 2 years (hereafter, BWLWHI) in: 1) cognitive and behavioral skills to access internal and external sources of strength (e.g. self-reliance, safety net); safety strategies, knowledge about Undetectable = Untransmissible (U=U) and HIV care; and reduce internalized and anticipated stigma; 2) communication skills to respond to enacted HIV and IPV stigma and enlist social support; and 3) addressing structural barriers to HIV care engagement with an HIV navigator component. The intervention is informed by the HIV-Stigma Framework and a resilient-reintegration model which views women as active participants in responding to IPV and managing life with HIV.

Aim 1: Examine preliminary efficacy of the 1MoreStep intervention on: (a) IPV safety strategies (informal and formal resources, safety planning, and placating strategies at baseline, 3-month and 6-month follow-up visits); and (b) HIV care engagement (medical record confirmed visit with an HIV care provider, antiretroviral therapy (ART) prescription, medication adherence, and viral load status during 3-month and 6-month follow-up visits).

Aim 2: Examine the acceptability and feasibility of the 1MoreStep intervention operationalized by (a) quantitative measures: session attendance and fidelity to key intervention components and (b) qualitative interviews to assess: program fit, facilitators and barriers to participation, and using 1MoreStep intervention skills.


Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings 

Study Type: Interventional
Start Date: April 24, 2023
Eligibility: Females, 18 Years to 25 Years, Does Not Accept Healthy Volunteers
Location(s): Wits Reproductive Health Institute, Johannesburg, Gauteng, South Africa

Adolescent girls and young women (AGYW) at risk of HIV in sub-Saharan Africa, frequently (20-50%) have symptoms of common mental disorders, including depression, anxiety, and stress. These symptoms are associated with suboptimal adherence to HIV pre-exposure prophylaxis (PrEP), a highly effective HIV prevention approach. In this project, the team seeks to address poor mental health and consequent impacts on PrEP adherence and among AGYW at risk of HIV by testing an evidence-based mental health intervention (the Youth Friendship Bench SA) adapted for PrEP delivery programs.


In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression 

Study Type: Interventional
Start Date: March 13, 2023
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Denver Health Medical Center, Denver, Colorado, United States

The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.


Helping HAND: Healing Anorexia Nervosa Digitally 

Study Type: Interventional
Start Date: December 1, 2022
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Washington University School of Medicine, Saint Louis, Missouri, United States

The proposed project will develop and pilot a coached mobile app, including a social networking component, for individuals with anorexia nervosa to use in the post-acute period


Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms: Impact on Child Development 

Study Type: Interventional
Start Date: November 18, 2022
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

The long-term goal is to develop effective parenting strategies to facilitate optimal child development for mothers suffering with PPD symptoms. The overall objective for this application is to study whether this program combined with online depression treatment leads to more responsive parenting (target) and signals improved child language, socioemotional and cognitive development (outcomes) compared to depression treatment alone. Findings from this application can be used to inform a future study to test the effectiveness and implementation of this social media-based parenting program.


Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement 

Study Type: Interventional
Start Date: November 15, 2022
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): The Regents of the Univ. of Calif., U.C. San Diego, La Jolla, California, United States

A two-arm RCT will be conducted to test the efficacy of Women SHINE, a web-based trauma-informed peer navigation-social support intervention (Figure 2). A total of 360 women living with HIV/AIDS (WLHA) with a history of adulthood interpersonal violence who have been prescribed ART but are non-adherent (< 90% ART adherent in the last 4 weeks) will be enrolled in the study. WLHA will be randomized (1:1) into one of the following conditions: 1) Women SHINE intervention arm (n=180) or 2) Control arm (n=180). The Women SHINE intervention arm will receive a four-month intervention including peer navigator (PN) one-on-one sessions, phone/text-based check-ins, 7 psychoeducation weekly support group sessions (120 mins.) co-facilitated by a licensed therapist and PN, and access to a static website with resources for HIV care, interpersonal violence, trauma, mental health, and substance use. The control arm will receive one group session (60 mins.) on self-care and well-being and access to the aforementioned website with resources. Women will complete a video-based survey and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization, to evaluate improvements in ART adherence (Aim 1), emotion regulation, and PTSD symptoms (Aim 2). Investigators will examine the mediating effect of individual (retention in HIV care, coping self-efficacy, social support, ancillary support services use) and socio-structural (stigma, medical mistrust) mechanisms of change on the efficacy of Women SHINE (Aim 3).


A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care 

Study Type: Interventional
Start Date: November 1, 2022
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Amritha Bhat, Seattle, Washington, United States

The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention.


Clinic-based HIV Identification and Prevention Project Using Electronic Resources 

Study Type: Interventional
Start Date: October 3, 2022
Eligibility: Females, 15 Years to 65 Years, Accepts Healthy Volunteers
Location(s): Johns Hopkins Health System, Baltimore, Maryland, United States

Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.


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.


Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care 

Study Type: Interventional
Start Date: June 9, 2022
Eligibility: Females, 16 Years to 99 Years, Accepts Healthy Volunteers
Location(s): Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

The goal of the proposed research is to test the feasibility and acceptability of a virtual group session which is intended to be offered universally to Spanish-speaking parents of newborns/infants attending pediatric primary care. The virtual session is intended to (1) enhance patient/family education about postpartum depression (PPD) and (2) Provide an orientation to families regarding relevant clinic and community psychosocial support resources available. The investigators will conduct a single-arm, open pilot of the session, which will be co-delivered by existing clinic staff (including social work and community outreach staff). Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs. The overall aim of the project is to Develop and pilot a virtual group augmentation of standard individual well-child care to improve (1) clinic screening procedures, discussion about and initial management of maternal depressive symptoms with immigrant Latinas and (2) patient symptom recognition, symptom disclosure, and subsequent treatment engagement


Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care 

Study Type: Interventional
Start Date: April 26, 2022
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Malvern Clinic, Johannesburg, Gauteng, South Africa

This quasi-experimental feasibility study recruit n=40 participants from each of two public antenatal clinics in Johannesburg, South Africa. Using the Bowen et al. approach, key feasibility study questions will be those around acceptability, implementation, and promising effects on intermediate variable. While this pilot trial is not powered to determine efficacy, it can help establish whether intervention targets the appropriate intermediate mechanisms (i.e. primary endpoints of IPV exposure and depressive symptoms) and moves intended outcomes in the right direction (i.e. towards better adherence as measured by self-reported adherence).


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.


Examining the Effects of Estradiol on Neural and Molecular Response to Reward 

Study Type: Interventional
Start Date: April 20, 2022
Eligibility: Females, 45 Years to 55 Years, Does Not Accept Healthy Volunteers
Location(s): University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

This proposal will examine the effects of estradiol administration on perimenopausal-onset (PO) anhedonia and psychosis symptoms as well as on brain function using simultaneous positron emission tomography and functional magnetic resonance imaging (PET-MR).


Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya 

Study Type: Interventional
Start Date: February 24, 2022
Eligibility: Females, 16 Years to 24 Years, Accepts Healthy Volunteers
Location(s): Partners in Health and Research Development, Thika, Kenya

Few young women at risk of HIV infection are initiating pre-exposure prophylaxis (PrEP) for HIV prevention in Kenya, thus we propose refining and testing a new model to increase PrEP initiation among young women at high HIV risk that has never been explored: peer PrEP referral + HIV self-test (HIVST) delivery. We conducted formative research to design of a model that is acceptable to young women and feasible to implement in Kenya. In this study, we will refine this model where young (≥16 to 24 years) female PrEP users refer their peers to PrEP and deliver HIVSTs in a pilot study and then test the refined model in a hybrid effectiveness-implementation trial. We hypothesize that relative to informal word-of-month peer PrEP referral (currently ongoing in Kenya), formalized peer PrEP referral + HIVST delivery will increase PrEP adoption (i.e., initiation, retention, and adherence) among peers, and be low cost and have high fidelity in Kenya.


Increasing HIV/STI Home Testing Via a Digital Intervention Among Black Women 

Study Type: Interventional
Start Date: February 2, 2022
Eligibility: Females, 15 Years to 59 Years, Accepts Healthy Volunteers
Location(s): Johns Hopkins Bloomberg School of Public Health, Houston, Texas, United States; Johns Hopkins Bloomberg School of Public Health, Dallas, Texas, United States; Johns Hopkins Bloomberg School of Public Health, Austin, Texas, United States; Johns Hopkins Bloomberg School of Public Health, San Antonio, Texas, United States

The proposed intervention is a web-based intervention guided by theoretical components to increase HIV home testing among Black women at risk for HIV and sexually transmitted infections (STIs) in a HIV hotspot in the South. The intervention will promote using the home test, linkage to care, and linkage to pre-exposure prophylaxis (PrEP) evaluation. The intervention has the potential to be implemented on a large scale and tailored based on location and population to increase testing, treatment, and PrEP adoption.


Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya 

Study Type: Interventional
Start Date: January 1, 2022
Eligibility: Females, 15 Years to 100 Years, Accepts Healthy Volunteers
Location(s): Ober Health Center, Homa Bay, Kenya

This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.


Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum 

Study Type: Observational
Start Date: September 1, 2021
Eligibility: Females, Age N/A, Does Not Accept Healthy Volunteers
Location(s): Famcru Crs, Tygerberg Hills, South Africa; Baylor-Uganda CRS, Kampala, Uganda; Chiangrai Prachanukroh Hospital NICHD CRS (Site ID: 5116), Chiang Rai, Thailand; Siriraj Hospital, Mahidol University NICHD CRS, Bangkok, Bangkoknoi, Thailand; Sizwe CRS, Johannesburg, South Africa; Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS, Cape Town, South Africa; Wits RHI Shandukani Research, Johannesburg, Gauteng, South Africa; IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS, San Juan, Puerto Rico; Kenya Medical Research Institute / Walter Reed Project Clinical Research Center, Kericho CRS, Kericho, Kenya; Byramjee Jeejeebhoy Medical College (BJMC) CRS, Pune, Maharashtra, India; Hosp. Geral De Nova Igaucu Brazil NICHD CRS, Rio De Janeiro, Brazil; Hospital Federal dos Servidores do Estado NICHD CRS, Rio De Janeiro, Brazil; SOM Federal University Minas Gerais Brazil NICHD CRS, Belo Horizonte, Brazil; Univ. of Sao Paulo Brazil NICHD CRS (Site ID: 5074), Ribeirão Preto, São Paulo, Brazil; Gaborone CRS (Site ID: 12701), Gaborone, South-East District, Botswana; Molepolole CRS (Site ID: 12702), Molepolole, Kweneng District, Botswana; Baylor College of Medicine/ Texas Children's Hospital NICHD CRS (Site ID: 5128), Houston, Texas, United States; St. Jude Children's Research Hospital CRS, Memphis, Tennessee, United States; SUNY Stony Brook NICHD CRS, Stony Brook, New York, United States; Jacobi Med. Ctr. Bronx NICHD CRS, Bronx, New York, United States; Bronx-Lebanon Hospital Center NICHD CRS, Bronx, New York, United States; Johns Hopkins Univ. Baltimore NICHD CRS, Baltimore, Maryland, United States; Lurie Children's Hospital of Chicago (LCH) CRS (Site ID: 4001), Chicago, Illinois, United States; Rush University Cook County Hospital Chicago NICHD CRS, Chicago, Illinois, United States; Emory University School of Medicine NICHD CRS, Atlanta, Georgia, United States; Pediatric Perinatal HIV NICHD CRS, Miami, Florida, United States; University of Florida Jacksonville NICHD CRS, Jacksonville, Florida, United States; South Florida CDTC Ft Lauderdale NICHD CRS, Fort Lauderdale, Florida, United States; Univ. of Colorado Denver NICHD CRS, Aurora, Colorado, United States; University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program, San Diego, California, United States; David Geffen School of Medicine at UCLA NICHD CRS, Los Angeles, California, United States; Usc La Nichd Crs, Los Angeles, California, United States

The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.


A Wearable Morning Light Treatment for Postpartum Depression 

Study Type: Interventional
Start Date: June 23, 2021
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Michigan, Ann Arbor, Michigan, United States

This study will test a consumer health light therapy device (Re-Timer) for women with postpartum depression to better understand how it affects mood and the body clock (also called the circadian clock).

Eligible participants will be enrolled and randomized after baseline assessments. In addition to using the Re-Timer light for 5 weeks participants will complete questionnaires at various timepoints, record sleep information, wear an actigraph watch, and provide saliva samples. Additionally, the sleep of the participants' infants will also be monitored using an ankle-worn device (actigraph) and sleep diary at certain time-points as this may influence the mother's mood/sleep, and in turn affect the results.

The hypotheses regarding the bright light versus the placebo dim light of the study are:

morning bright light therapy will produce greater improvement from pre- to post-treatment on the Hamilton Rating Scale for Depression morning bright light therapy will lengthen the Phase angle difference (PAD) and this will mediate change in depression symptoms. morning bright light therapy will produce greater improvements on self-reported depression symptoms, excessive daytime sleepiness, maternal-infant bonding, social functioning, and sleep-related impairment from pre- to post-treatment.


PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya 

Study Type: Interventional
Start Date: March 1, 2021
Eligibility: Females, Age N/A, Accepts Healthy Volunteers
Location(s): Kenyatta National Hospital, Kisumu, Kenya

This a prospective, open-label implementation project to catalyze integration of HIV prevention and PrEP care services for adolescent girls and young women in family planning clinics in Kenya.


Improving Therapeutic Learning for PTSD 

Study Type: Interventional
Start Date: February 18, 2021
Eligibility: Females, 21 Years to 50 Years, Accepts Healthy Volunteers
Location(s): University of Texas, Austin, Texas, United States

The proposed project seeks to demonstrate the engagement of post-exposure dopamine neurotransmission and downstream acute reorganization of dopaminergic resting-state neural networks as a means of increasing consolidation of extinction memories formed during analogue exposure therapy in adult women with PTSD. Participants will include 120 women aged 21-50 with a current diagnosis of PTSD related to physical or sexual assault, English speaking, and medically healthy. Participants will complete the stages of the study across 2-3 days, depending on participant need.


A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa 

Study Type: Interventional
Start Date: February 18, 2021
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Cape Town, Cape Town, South Africa

ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. We propose a full-scale randomized controlled trial to examine the effect of ImpACT+ on clinical outcomes in the period after ART initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved. ImpACT+ will target women who are initiating ART in order to take advantage of a window of opportunity in HIV care and maximize care engagement. The aims are to test the effectiveness of ImpACT+ and explore its potential for implementation.


Self-Control in Bulimia Nervosa 

Study Type: Interventional
Start Date: September 18, 2020
Eligibility: Females, 18 Years to 35 Years, Accepts Healthy Volunteers
Location(s): Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai, New York, New York, United States

This study examines the influence of acute fasting and eating on self-control in adult females with and without bulimia nervosa (BN). Specifically, the study team is investigating whether differences in behavior and brain activation in response to computer tasks after fasting and after eating a meal could help to explain the symptoms of bulimia nervosa. Data will be collected using questionnaires and a technology called magnetic resonance imaging (MRI).


Neuroendocrine Risk for PTSD in Women 

Study Type: Interventional
Start Date: November 11, 2019
Eligibility: Females, 18 Years to 35 Years, Does Not Accept Healthy Volunteers
Location(s): Grady Memorial Hospital, Atlanta, Georgia, United States

This study will test for effects of estradiol (E2) on PTSD symptoms and functional magnetic resonance imaging (fMRI) indicators of stress vulnerability, in naturally-cycling women who are not using hormonal birth control. Enrollment will be targeted to create three groups within two cohorts (early follicular phase and luteal phase):

PTSD: Women who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for PTSD Trauma-Exposed (TC): Women matched for age and trauma exposure severity but without PTSD Healthy Control (HC): Women matched for age, but without trauma history or psychiatric disorder (self-reported)

Women will be recruited through Grady Trauma Project (GTP), a large longstanding study of civilian trauma and PTSD conducted at Grady Memorial Hospital in Atlanta, Georgia.


Adolescent Attention to Emotion Study 

Study Type: Interventional
Start Date: October 16, 2019
Eligibility: Females, 13 Years to 15 Years, Accepts Healthy Volunteers
Location(s): Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania, United States

Rates of depression increase rapidly during adolescence, especially for girls, and, thus, research is needed to spur the development of novel interventions to prevent adolescent depression. This project seeks to determine if a novel visuocortical probe of affect-biased attention (i.e., steady-state visual evoked potentials derived from EEG) can 1) be used to prospectively predict depression using a multi-wave repeated measures design and 2) modify affect-biased attention and buffer subsequent mood reactivity using real time neurofeedback. This work could ultimately lead to improved identification of adolescents who are at high risk for depression and directly inform the development of mechanistic treatment targets to be used in personalized intervention prescriptions for high-risk youth.


Effects of an ER Beta Agonist (Lilly Compound LY500307) on Estradiol-Withdrawal-Induced Mood Symptoms in Women With Past Perimenopausal Depression 

Study Type: Interventional
Start Date: May 23, 2019
Eligibility: Females, 45 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Some women who had depression in the perimenopause may have mood symptoms again if they stop estrogen therapy. Estrogen acts in the brain and other tissues by binding to at least three types of estrogen receptors. One of these receptors, estrogen receptor beta may affect anxiety and depression. The drug LY500307 acts only on this receptor. In this study, researchers will initially give you estrogen and then suddenly stop estrogen after three weeks. Then they will study how LY500307 affects mood symptoms.

Objectives:

To study how withdrawing estradiol affects mood. To test the safety and side effects of LY500307.

Eligibility:

Healthy women ages 45-65 who had depression related to perimenopause in recent years and whose mood systems got better with estradiol

Design:

-Participants will be screened with:

Medical history

Physical exam

Blood tests

Psychiatric interview

Gynecological exam

Participants able to get pregnant must use effective barrier birth control throughout the study. During the first 3 weeks, participants will wear an estrogen patch. It is 1x2 inches and will be replaced every 3 days. For the next 3 weeks, participants will take 3 study capsules every morning. They will not know if they get the study drug or placebo. Some participants will also take a progesterone-like drug for 1 week at the end of the medication phase of the study. Participants will have 9 one-hour study visits. They will have blood samples and vital signs taken. They will answer questions about mood and behavior symptoms. Participants will keep a daily log of these symptoms. Participants will have 2 transvaginal ultrasounds. A probe is temporarily placed 2-3 inches into the vaginal canal and sound waves are used to create pictures of the lining of the uturus. Participants will have a final visit 4 weeks after stopping the study drug. They will answer questions about mood and side effects.


Neuroeconomics of Social Behavior Following Trauma Exposure 

Study Type: Observational
Start Date: November 14, 2017
Eligibility: Females, 18 Years to 45 Years, Accepts Healthy Volunteers
Location(s): McLean Hospital, Belmont, Massachusetts, United States

This study will use a neuroeconomic paradigm with state-of-the-art imaging protocols to probe abnormal social reward processing underlying social withdrawal in symptomatic trauma-exposed women. By also gathering self-report measures of social anhedonia, performance on non-social and social reward valuation tasks, and measures of real-world social functioning including social network size, we aim to specify how alterations in social reward processing result in social withdrawal and functional impairment.


Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders 

Study Type: Interventional
Start Date: July 10, 2017
Eligibility: Females, 18 Years to 34 Years, Does Not Accept Healthy Volunteers
Location(s): Stanford University, Stanford, California, United States

Most people with an eating disorder (ED) do not receive good treatment. The investigators have developed a new brief group treatment that is supposed to work by reducing how much women with an ED value the impossible thinness standard promoted by the media and how much they value/crave binge foods. The investigators want to test whether the treatment actually changes those two mechanisms using brain scan data, which is more objective than completing questionnaires and even interviews.

In the first phase of the study (R61), the investigators will compare women in the treatment versus those on a wait-list. If the investigators can show that the treatment "works" (does what the investigators think it does) compared to no active treatment (women will be allowed to seek and receive outside help but investigators will not provide it until after the wait-list), investigators will conduct the second phase of study (R33),where they will randomly assign women with an ED to either the new treatment or to a group treatment that represents what many college mental health clinics provide to their clients with ED.


Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships 

Study Type: Interventional
Start Date: March 31, 2008
Eligibility: Females, 18 Years to 64 Years, Does Not Accept Healthy Volunteers
Location(s): Grady Hospital, Atlanta, Georgia, United States

This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.


The Role of Hormones in Postpartum Mood Disorders 

Study Type: Interventional
Start Date: April 26, 1996
Eligibility: Females, 18 Years to 50 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Determine whether postpartum depression is triggered by the abrupt withdrawal of estrogen and progesterone.

The appearance of mood and behavioral symptoms during pregnancy and the postpartum period has been extensively reported. While there has been much speculation about possible biologically based etiologies for postpartum disorders (PPD), none has ever been confirmed. Preliminary results from two related studies (protocols 90-M-0088, 92-M-0174) provide evidence that women with menstrual cycle related mood disorder, but not controls, experience mood disturbances during exogenous replacement of physiologic levels of gonadal steroids. The present protocol is designed to create a "scaled-down" hormonal milieu of pregnancy and the puerperium in order to determine whether women who have had a previous episode of postpartum major effective episode will experience differential mood and behavioral effects compared with controls and to determine whether it is the abrupt withdrawal of gonadal steroids or the prolonged exposure to gonadal steroids that is associated with mood symptoms. Supraphysiologic plasma levels of gonadal steroids will be established, maintained, and then rapidly reduced, simulating the hormonal events that occur during pregnancy and parturition. This will be accomplished by administering estradiol and progesterone to women who are pretreated with a gonadotropin releasing hormone (GnRH) agonist (Lupron). After eight weeks, administration of gonadal steroids will be stopped in one group of patients and controls, and a sudden decline in the plasma hormone levels will be precipitated. Another group will be maintained on supraphysiologic levels of estrogen and progesterone for an additional month. Outcome measures will include mood, behavioral and hormonal parameters (a separate protocol done in collaboration with NICHD).


Study of Premenstrual Syndrome and Premenstrual Dysphoria 

Study Type: Observational
Start Date: March 9, 1984
Eligibility: Females, 18 Years to 50 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

The purpose of this study is to identify and describe the symptoms of premenstrual syndrome (PMS).

Women who experience PMS symptoms will complete clinical interviews, self-rating scales, and evaluations of mood and endocrine function. A subgroup of women with severe PMS (Premenstrual Dysphoric Disorder or PMDD) will be offered additional research studies that focus on: 1) identifying the endocrine changes that may be responsible for changes in mood and behavior during the premenstrual period, 2) evaluating treatments for PMS symptoms, and/or 3) identifying genetic factors in women with and without PMS. Women with recurrent brief depression will also be recruited to serve as a comparison group.