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Transforming the understanding
and treatment of mental illnesses.

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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For opportunities to participate in NIMH research on the NIH campus, visit the clinical research website. Travel and lodging assistance may be available.

Featured Studies

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


MyPEEPS Mobile for Young Transgender Men

Study Type: Interventional
Start Date: June 30, 2023
Eligibility: Females, 15 Years to 19 Years, Accepts Healthy Volunteers
Location(s): Callen-Lorde Community Health Center, New York, New York, United States; Ann & Robert H. Lurie Children's Hospital Chicago, Chicago, Illinois, United States; Columbia University, New York, New York, United States

Transgender youth in the United States have unique health needs but often face barriers to accessing and receiving health care services which contribute to disparate health outcomes, including high vulnerability to HIV and other sexually transmitted infections. The proposed MyPEEPS intervention for young transgender men is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information to high risk youth. The final product will be the basis for conducting a large-scale efficacy study in this population.


Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women

Study Type: Interventional
Start Date: July 20, 2022
Eligibility: Females, 18 Years to 45 Years, Accepts Healthy Volunteers
Location(s): Virginia Commonwealth University, Richmond, Virginia, United States

The purpose of this research study is to learn more about the economic situations, discrimination experiences, and risk behaviors of transgender women. The ultimate purpose of the study is to test an intervention to improve financial conditions and reduce HIV risk behaviors in transgender women.


Estrogen Variability and Irritability During the Menopause Transition

Study Type: Interventional
Start Date: June 15, 2022
Eligibility: Females, 45 Years to 55 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 1, 2022
Eligibility: Females, 44 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.


Mobile HIV Prevention App for Black Women

Study Type: Interventional
Start Date: February 5, 2022
Eligibility: Females, 18 Years to 44 Years, Accepts Healthy Volunteers
Location(s): Center for Black Women's Wellness, Atlanta, Georgia, United States

Black women have a significantly higher risk of acquiring HIV compared to their non-Black counterparts.

The purpose of this study is to refine and test a mobile HIV Prevention and Reproductive Health app developed specifically for Black women.


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.


Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in South Africa

Study Type: Interventional
Start Date: November 12, 2021
Eligibility: Females, 18 Years and Older, Accepts Healthy Volunteers
Location(s): HIV Clinic, Johannesburg, Gauteng, South Africa

This study will evaluate the impact of the Common Elements Treatment Approach (CETA), an evidence-based intervention comprised of cognitive-behavioral therapy elements, at improving HIV treatment outcomes among women with HIV who have experienced intimate partner violence (IPV) and have an unsuppressed viral load on HIV treatment. To evaluate CETA, the investigators will conduct a randomized controlled trial of HIV-infected women, with or without their partners, who have experienced IPV and have an unsuppressed viral load to test the effect of CETA in increasing viral suppression and reducing violence. The investigators will also identify mediators and moderators of CETA's effect on retention and viral suppression and assess the cost and cost-effectiveness of CETA vs. active control at increasing the proportion who are retained and virally suppressed by 12 months.


Accelerating Implementation of Mindful Mood Balance for Moms

Study Type: Interventional
Start Date: September 27, 2021
Eligibility: Females, 18 Years and Older, Accepts Healthy Volunteers
Location(s): Kaiser Permanente Colorado, Denver, Colorado, United States; Kaiser Permanente Southern California, San Diego, California, United States; Kaiser Permanente Georgia, Atlanta, Georgia, United States; HealthPartners, Bloomington, Minnesota, United States

The Mindful Mood Balance for Moms (MMBFM) study examines whether using an internet program called Mindful Mood Balance for Moms to deliver Mindfulness Based Cognitive Therapy (MBCT) over an 8-week time period, is effective for reducing depression symptoms among pregnant women with a history of prior depression, and studies the effects of implementation strategies on the reach of the MMBFM program. This study will enroll 470 women from Kaiser Permanente Colorado, Southern California, Georgia.

The investigators will compare clinical outcomes between those that receive mental health clinician coaching and those that receive peer coaching throughout the 8-week program. Survey data will be collected at 4 time points throughout the study (baseline, 12 weeks, 3rd trimester, and 3 months postpartum). The cost-effectiveness of both the clinical and peer coaching models at each health care system will be evaluated.

For the implementation portion of the study, 30 OB clinics across the 4 health systems will be randomized in equal numbers to provide clinician facing implementation strategies (e.g., recruitment flyers, script pads, electronic medical record prompts) to encourage engagement in the MMBFM program or to usual care where women are only recruited by the study team with no clinician involvement. The primary outcome for testing clinician facing implementation strategies is reach, the percentage of women outreached who initially engage in the MMBFM program.


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.


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

Study Type: Observational
Start Date: June 8, 2021
Eligibility: Females, Age N/A, Does Not Accept Healthy Volunteers
Location(s): Siriraj Hospital, Mahidol University NICHD CRS, Bangkok, Bangkoknoi, Thailand; Wits RHI Shandukani Research, Johannesburg, Gauteng, South Africa; IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS, San Juan, Puerto Rico; Rush University Cook County Hospital Chicago NICHD CRS, Chicago, Illinois, United States; University of Florida Jacksonville NICHD CRS, Jacksonville, Florida, United States; South Florida CDTC Ft Lauderdale NICHD CRS, Fort Lauderdale, Florida, 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.


PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

Study Type: Interventional
Start Date: May 1, 2021
Eligibility: Females, Age N/A, Accepts Healthy Volunteers
Location(s): Madiany Sub County Hospital, Siaya, Kenya; Uyawi Sub County Hospital, Siaya, Kenya; Malanga Health Center, Siaya, Kenya; Bondo County Referral Hospital, Siaya, Kenya; Nyahera Sub Sub County Hospital, Kisumu, Kenya; Masogo Sub-County Hospital, Kisumu, Kenya; Ober Health Center, Homa Bay, Kenya; Kendu Sub-District Hospital, Homa Bay, Kenya

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


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 Wisconsin, Madison, Wisconsin, 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.


Collaborative Care for Perinatal Depression Care in Vietnam

Study Type: Interventional
Start Date: December 1, 2020
Eligibility: Females, 16 Years to 45 Years, Does Not Accept Healthy Volunteers
Location(s): Tan Thoi Commune Health Center, Cần Thơ, Vietnam; My Khanh Commune Health Center, Cần Thơ, Vietnam

Depression is the most common medical disorder of pregnancy, and suicide, most frequently found in women with depression, is a major source of maternal mortality. Perinatal depression affects approximately 15% of women in pregnancy and the year postpartum and affects both women and their children, both medically and as a result of impairment in the ability to care for self and others. In low- and middle-income countries (LMICs) where food insecurity can be severe, growth stunting is seen among the infants of women with untreated depression. Fortunately, effective treatment of perinatal depression with antidepressant medications and evidence-based psychosocial interventions (such as collaborative care) mitigates these risks. Yet there are a range of obstacles within LMICs to the delivery of services for perinatal depression and maternal suicide prevention, including a lack of awareness of this disorder and related evidence-based treatments, stigma among patients and providers, scarcity of specialty mental health care providers, and the lack of health information technology supports for the longitudinal care of chronic illness.


Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya

Study Type: Interventional
Start Date: October 5, 2020
Eligibility: Females, Age N/A, Does Not Accept Healthy Volunteers
Location(s): Mariakani Subcounty Hospital, Mariakani, Kilifi, Kenya; Vipingo Subcounty Hospital, Vipingo, Kilifi, Kenya; Likoni Subcounty Hospital, Likoni, Mombasa, Kenya; Ambira Subcounty Hospital, Ambira, Siaya, Kenya; Bondo Subcounty Hospital, Bondo, Siaya, Kenya; Malanga Subcounty Hospital, Malanga, Siaya, Kenya; Sigomere Health Center, Sigomere, Siaya, Kenya; Ukwala Subcounty Hospital, Ukwala, Siaya, Kenya; Yala Subcounty Hospital, Yala, Siaya, Kenya; Akala Subcounty Hospital, Siaya, Kenya; Siaya County Hospital, Siaya, Kenya; Mtwapa Subcounty Hospital, Mtwapa, Kilifi, Kenya

The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts for providers) to increase retention in guideline-adherent prevention of mother-to-child transmission of HIV services (PMTCT) and to increase viral suppression and appropriate clinical action through the extended period of 6 months postpartum, compared to standard of care PMTCT services in a matched, cluster randomized controlled trial.


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.


The PrEP (Pre-exposure Prophylaxis) SMART Study

Study Type: Interventional
Start Date: May 16, 2019
Eligibility: Females, 18 Years to 25 Years, Accepts Healthy Volunteers
Location(s): Wits Reproductive Health and HIV Institute, Johannesburg, South Africa

The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.


Effects of Glucocorticoids on Cognition in HIV-infected Women

Study Type: Interventional
Start Date: November 20, 2017
Eligibility: Females, 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

Despite treatment with antiretroviral therapy, women living with HIV continue to experience cognitive impairment. Psychological risk factors, including stress, impair cognition more in HIV-infected women than HIV-uninfected women. This study plans to examine a novel intervention for cognitive dysfunction that targets the mechanisms by which stress negatively affects cognitive functioning.


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.


Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

Study Type: Interventional
Start Date: September 1, 2017
Eligibility: Females, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Denver, Denver, Colorado, United States

This study evaluates Interpersonal Therapy (IPT) in the treatment of depression among pregnant women with elevated depressive symptoms. Half of the women will be randomized to receive IPT, and the other half will get Treat As Usual, provided via behavioral health in the hospital.


Feasibility of Implementing a Mental Health Care Program and Home-based Training for Mothers of Children With Autism Spectrum Disorder in an Urban Population in Bangladesh

Study Type: Interventional
Start Date: April 1, 2017
Eligibility: Females, 18 Years to 50 Years, Does Not Accept Healthy Volunteers
Location(s): Awf, Swac, Dhaka, Bangladesh

Background (brief):

The global burden of depression accounts for 2.5% of global DALYs, and in South Asia the estimate is 13.3 % of DALYs per 100,000 populations. Mothers of children with Autism Spectrum Disorder (ASD) have reported higher level of depression than mothers of children with other developmental disorder and the prevalence of ASD is high in Asian countries. In Bangladesh 16% of adults suffer from depression and a recent study conducted in Bangladesh has documented a high prevalence of depression among mothers of children with ASD (45%). Mothers are the life time care givers of children with ASD, and a high burden of depression is likely negatively impact on the ability of the mothers to provide care to children at home. Mental health is not addressed in Bangladesh and there is scarcity of qualified providers.

Objectives:

The investigators propose to pilot the feasibility of a package intervention including implementation of mental health care and home based training program for the mothers of children with ASD integrated in the regular activities of the special schools that offer ASD care in Dhaka city in Bangladesh.

Methods:

The study will be conducted in 2 selected special schools over 15 months. In the first stage, the investigators will set up the study in two schools and identify various stakeholders for qualitative assessment of the barriers of implementing the intervention at the institutional level, individual level, family level, provider level, policy maker level and at the level of the state. Research staff will identify mothers 18 years of age or older who has a child with ASD between 3 and 17 years of age enrolled in the school. Following consent, data collector will obtain data and assess current major depressive episode (MDE) of the eligible mothers following a standard diagnostic tool (SCID-I). All mothers diagnosed as having MDE will be invited to participate in the intervention (intervention mothers) and the investigators will assess the performances in children with ASD by applying ASD Diagnostic Check-list (ADCL).

In the second stage, investigators will implement interventions over 4-6 months, including (a) implementing mental health care services at the selected schools targeting the intervention mothers, and (b) organizing training sessions of the intervention mothers for supporting child care at home for enhancing child performances. Every month a psychiatrist will visit each school for providing necessary advice and treatment to the intervention mothers or suggest referral to hospital care, if necessary.

One special educator will be deployed at each school who will organize structured training sessions for educating the intervention mothers by using BCC materials developed and validated by icddr,b in the local setting. The special educators will conduct multiple group sessions including 5-8 mothers in each group for covering the 6 modules over 2 weeks time, and follow up intervention mothers at home every month for conducting refresher's training, documenting the need of additional training supports, and linking mother with an ASD expert for helping mothers taking a decision.

In stage 3, investigators will conduct post intervention qualitative survey with various stakeholders who would be involved with implementing the intervention and participated in the baseline qualitative survey. End line assessment will be conducted of current major depressive episode (MDE) among all mothers and assess the performance of the children of intervention mothers in order to assess the impact of the training at home.

Outcome measures/variables:

The primary outcome of the study is to assess the feasibility of institutionalizing the combined intervention of mental health care supports and the home based training program of the mothers who would be diagnosed as having major current major depressive episode. The primary outcome will be assessed by obtaining the perspectives of various stakeholders. The following parameters will be assessed for measuring feasibility of the proposed intervention.

Acceptability, Adaptability, Demands, Practicality, Implementation, Integration

The secondary outcomes will include estimating the impact of the combined interventions on the prevalence rate of maternal depression (MDE), individual performances of children, and cost of intervention. Adaptation of the proposed strategy, if feasible will help the mothers of children with ASD become skilled workforces for filling in the gap of the special educators in resource poor settings, and extension of these services to more children with ASD.


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).


Perimenopause-Related Mood and Behavioral Disorders

Study Type: Observational
Start Date: January 25, 1993
Eligibility: Females, 40 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 investigate mood and behavior changes in the time period surrounding and including menopause. This is an observational study; volunteers who participate will not receive any new or experimental therapies.

Controversy exists regarding the relationship between estrogen and progesterone (gonadal steroid) changes and midlife-onset depression. This study will examine the role of gonadal steroids in perimenopausal mood and behavioral disorders.

Perimenopausal women with depression symptoms and a control group of healthy perimenopausal volunteers will be compared to identify correlates of the occurrence of depression. Participants with depressive symptoms may also participate in companion studies that will test the antidepressant efficacy of phytoestrogens and selective estrogen receptor modulators (SERMS).

A group of younger pre-perimenopausal women with normal menstrual cycle functioning will be followed through menopause in an effort to confirm the association of depression onset with changes in reproductive endocrine functioning....


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.