Clinical Research Directory

Natural History of Depression, Bipolar Disorder and Suicide Risk

Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide. People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254. This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time. Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation....

AI Mental Health Tool vs. Psychoeducation Control

The goal of this clinical trial is to learn if Ash, an AI chat tool for mental health, works better than static psychoedcuation in reducing mental health symptoms. Participants must be new users to the Ash app and have at least moderate symptoms of depression. The main questions it aims to answer are: * Does using Ash for 4 weeks lower depression symptoms more than 4 weeks of regularly presented psychoeducation? * Does using Ash change anxiety, sleep, stress, and other symptoms more than psychoeducation? Researchers will compare two groups to see if Ash works as well as therapy: * One group will get free access to Ash right away. * The other group will get 4 weeks of regularly presented psychoeducation, then get free access to Ash afterward. Participants will: * Fill out an online survey about their symptoms at the start of the study * Use Ash or receive psychoeducation, depending on their group * Fill out follow-up surveys about their symptoms and well-being at 2, 4, 8, and 36 weeks * Complete all study activities online; no in-person visits are required

Cancer Pain Management Using a Web-based Intervention

This study is funded by the HEAL Initiative (https://heal.nih.gov/). Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching/support program for cancer pain management (CAPA) that was culturally tailored to Asian American breast cancer survivors using multiple unique features. However, CAPA rarely considered depressive symptoms accompanying pain in its design or components, and PSs indicated the necessity of further individualization of the intervention components of CAPA due to diversities in the needs of ABD. The purpose of the proposed 2-phase study is to further develop CAPA with additional components for ABD and the individual optimization functionality (CAI) and to test the efficacy of CAI in improving cancer pain experience of ABD. The specific aims are to: a) develop and evaluate CAI through an expert review and a usability test (R61 phase); b) determine whether the intervention group (that uses CAI and usual care) will show significantly greater improvements than the active control group (that uses CAPA and usual care) in primary outcomes (cancer pain management and cancer pain experience including depressive symptoms) from baseline to post 1-month and post 3-months; c) identify theory-based variables (attitudes, self-efficacy, perceived barriers, and social influences) that mediate the intervention effects of CAI on the primary outcomes; and d) determine whether the effects of CAI on the primary outcomes are moderated by selected background, disease, genetic, and situational factors. This study is guided by the Bandura's Theory and the stress and coping framework by Lazarus and Folkman. The R61 phase includes: (a) the intervention development process, (b) a usability test among 15 ABD, 15 family members, and 15 community gatekeepers; and (c) an expert review among 10 experts in oncology. The R33 phase adopts a randomized repeated measures control group design among 300 ABD. Long-term goals are: (a) to extend and test CAI in various healthcare settings with diverse subgroups of ABD, (b) examine the costeffectiveness, sustainability, and scalability of CAI in the settings, and (c) translate CAI into health care for ABD.

e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss

This study is part of the e-Perinatal project and is embedded within the parent e-Perinatal cluster randomized controlled trial (NCT07613008). No additional randomization is performed for this embedded study. Women participating in the parent trial who experience early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life, together with their participating partners, are eligible for this study. Participants retain the study-group allocation assigned to their primary healthcare center in the parent trial. Participants from clusters allocated to the intervention arm are offered access to the e-Perinatal Butterfly web-app as a complementary component of the e-Perinatal intervention. The e-Perinatal Butterfly web-app provides tailored psychoeducational resources and digital support tools for parents experiencing perinatal bereavement. Participants from clusters allocated to the control arm continue to receive usual care. The primary objectives are to assess the feasibility and acceptability of the e-Perinatal Butterfly intervention. The study will also explore changes in symptoms of depression and anxiety among parents who have experienced a perinatal loss. Secondary exploratory analyses will examine longitudinal trajectories of depression and anxiety among bereaved participants and compare these trajectories between the intervention and control arms and with those observed in the broader cohort of the parent e-Perinatal trial

Treatment for Migraine and Mood

The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC).

Improving Student Mental Health Through a Universal Trauma-Informed Intervention

The goal of this trial is to identify the most effective ways for schools to deliver RAP Club, a universal school-based mental health intervention. RAP Club is an evidence-based group program designed to help 8th grade students manage stress, regulate emotions, and make healthy decisions. This study investigates two factors related to program implementation: type of program facilitator (teacher vs. school-based clinician) and level of facilitator supervision (standard vs. enhanced). The investigators will test four conditions that represent all combinations of these two factors. The main questions this study aims to answer are: * Which combination of facilitator type and supervision level is most effective for improving student mental health? * How much does each of the four conditions cost, and how cost-effective, practical, and acceptable is each? The investigators will work with 32 public schools. Each school will deliver two RAP Club groups with approximately 15 students per group. One group will be led by a school clinician and the other by a teacher. One of these facilitators will be randomized to receive weekly group supervision and the other to receive enhanced supervision, which also includes observation and coaching. The investigators will collect survey data on student mental health at baseline, after RAP Club, at 4-month follow-up, and at 12-month follow up when students are in 9th grade. The investigators will also collect academic data, program delivery data (e.g., attendance), and feedback from students, facilitators, and principals.

Testing the Feasibility and Impact of a Whole-Food Plant-Based Diet Intervention on College Students

The goal of this pilot randomized controlled trial (RCT) was to assess the feasibility, acceptability, and impacts of a whole-food plant-based (WFPB) vegan diet intervention for undergraduate university students randomly assigned, stratifying by sex and race/ethnicity, to one of two intervention groups (each with a distinct teaching-learning design, i.e., interactive (IA) versus lecture-based (LB)) and a control group. The main questions the researchers aimed to answer were: * Were the study procedures feasible and acceptable for the overall sample and were the intervention sessions, following a WFPB vegan diet, and the prospect of continuing this diet feasible and acceptable for the intervention participants? * Were there greater improvements in diet quality, WFPB vegan diet adherence, physical and mental health, and intrapersonal factor outcomes for the intervention group engaging in interactive learning compared to the intervention group learning through traditional lecture? And were there greater improvements in these outcomes for both intervention groups compared with the control group? The researchers compared the group outcome means for the two intervention groups against one another and those for the two intervention groups against those of the control group. Study participants completed two sets of measurements over the course of 6 weeks. * All participants completed online baseline and post-intervention surveys and in-person baseline and post-intervention biometric measurements. * Only the intervention group participants attended three 75-minute consecutive weekly intervention sessions to learn about different aspects of the WFPB vegan diet between the two sets of survey and biometric measurements.

Assessing the Effectiveness of Psychiatric Interventions on the Inpatient Unit

This study will monitor the symptoms of patients who have received an intervention on the psychiatric inpatient unit at Stanford hospital up to 6 months after they have received the intervention. Additionally, the acceptability and feasibility of interventions will be assessed using clinician and patient questionnaires.

Assessment of the Seasonality of Depressive Symptoms in Adolescents

The seasonality of affective disorders-particularly depressive symptoms-is well-documented in adults, yet it remains under-researched in adolescents. Recent studies, however, suggest that young people aged 11 to 20 experience marked seasonal fluctuations in mood. In both hospital pediatric settings and the ECLIPSE program, many adolescents are admitted due to depressive symptoms or suicidal crises; however, the role of seasonality in these cases remains largely unexplored. ECLIPSE (a Child and Adolescent Psychiatry Liaison and Emergency Consultation Team) is a service at the Rouen University Hospital dedicated to providing emergency and post-emergency care for children and adolescents experiencing psychological distress. It is designed for minors aged 3 to 16 whose psychological state requires prompt intervention, but not hospitalization. Clinical observation suggests that, for some patients, depressive manifestations follow an annual cycle. Identifying such seasonal patterns could help improve our understanding of vulnerability factors and enable the adaptation of prevention and care strategies. The Seasonal Pattern Assessment Questionnaire (SPAQ) (Reynaud et al., 2022)-used in adults (\>18 years old) to screen for seasonal affective disorder via a Global Seasonality Score (GSS)-is a simple, self-administered tool that can easily be used with adolescents. Its application in this context would allow for the assessment of the seasonality of depressive symptoms within this hospitalized population.

BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women

The goal of this clinical trial is to evaluate if the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices is able to improve depressive symptoms and sexual function in women who are perimenopausal or postmenopausal without an alternative medical cause before enrollment in the study and are aged 40 years and older. The main question it aims to answer is: Does the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices improve depressive symptoms and urinary incontinence? Participants will be asked to: Undergo twelve treatments Complete the Patient Health Questionnaire-9 Complete the 6-item Hamilton Depression Rating Scale Complete the Greene Climacteric Scale Complete the Therapy Comfort Questionnaire Complete the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Complete the Female Sexual Function Index Complete the Warwick-Edinburgh Mental Wellbeing Scale Complete the Columbia Suicide Severity Rating Scale-Screen version Complete the Subject Satisfaction Questionnaire Complete the Therapy Comfort Questionnaire

Rise & Thrive: Community-Engagement Intervention for Stress and Depression in Youth.

American youth and young adults face persistent and chronic stressors, which have contributed to a mental health crisis in the United States. Four in 10 American high school students experience chronic feelings of sadness and hopelessness, 2 in 10 report suicidal ideation, and 1 in 10 attempt suicide. For adolescents and young adults, chronic stress translates to weathering, or wear and tear on the mind and body. Chronic stress in youth contributes to psychological distress, elevated allostatic load, and an elevated risk for chronic diseases and premature death. While the connection between chronic stress and health is well documented, few studies provide evidence on innovative, non-medication strategies to reduce stress and mitigate the consequences of chronic stress on psychological and physiological outcomes. Thus, there is a critical need to rigorously test interventions that prevent the negative influence of chronic stress on mental and physical health, beginning in adolescence. The specific aims of the study are to 1) Determine whether a community-engagement, peer-based behavioral intervention reduces depressive symptoms in adolescents and young adults, 2) Determine whether a community-engagement behavioral intervention lowers allostatic load scores in adolescents and young adults, and 3) Identify factors that help sustain or inhibit community-engagement and intervention effects for adolescents and young adults. To accomplish these aims, the team will conduct a phase II community-engaged, peer group-based, multi-component randomized behavioral clinical trial. We will collect psychological and physiological measures at baseline, then at 6-month intervals for 2 years post-community-engaged, skills training.

Cannabis, Neuroinflammation, and Suicidal Ideation: A Supplemental Brain Imaging Study

This study will be the first to use brain imaging to explore how cannabis affects the brain and inflammation in U.S. military veterans with PTSD. It builds on an ongoing study testing different combinations of THC and CBD in 200 veterans. In this project, up to 100 veterans will complete brain scans before and after 12 weeks of cannabis administration to see how the brain changes over time. The scans will measure a marker sensitive to neuroinflammatory state, brain communication, and activity during thinking and emotion tasks. By linking these brain changes to improvements in PTSD symptoms, suicidal thoughts, and quality of life, this study may help identify which veterans benefit most from cannabis-based treatments and support more personalized care for PTSD.

Family Spirit Strengths

This project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in American Indian and Alaska Native communities. Access to culturally competent and effective behavioral health services is limited in many of these communities. The investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, Family Spirit Strengths (FSS) that can be embedded within home visiting services. The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), and materials informed and developed based on an Indigenous advisory group. The FSS program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. The investigators will use a randomized controlled trial, whereby half of the participants will receive FSS and the other half will receive an evidence-based nutrition education program. The investigators' study is grounded in participatory processes and led by a team of Indigenous and allied researchers.

Cannabidiol for Reduction of Brain Neuroinflammation

This study will investigate whether cannabidiol (CBD), the primary centrally and peripherally active non-intoxicating compound in the cannabis plant, exerts anti-neuroinflammatory effects in patients with chronic low back pain (cLBP) with or without mild-to-moderate depression.

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

The Michigan Men's Diabetes Project III: Mind \& Motion is an 7-month pilot randomized clinical trial. The investigators are looking to recruit 80 Black men with type 2 diabetes (T2D) (need to have diagnosis for at least one year) that are over the age of 18. Participants also must be under the care of a physician for their diabetes, self report an Hemoglobin A1c (A1C) of 7.0% or more in the last year, be willing to participate in study events (weekly physical activity, exercise and Cognitive Behavioral Therapy (CBT) sessions, group discussion sessions, and in-person health assessments), have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks, live in the Wayne or Washtenaw County, and have reliable transportation to in-person events. All participants will receive 8 hours/sessions of cognitive behavioral therapy. Participants randomized to the intervention arm will also receive 8 sessions of guided exercise at the same time. Following that they will also receive 8 group discussion sessions that will serve as on-going support. All sessions will be help via Zoom. Additionally, all participants will participate in The 4 health assessments will take place at baseline, 10 weeks, 18 weeks, and 30 weeks.

Interactive Effects of Early-Life Stress, Diet, and Metabolism on Gastrointestinal Dysfunction With Neuropsychiatric Symptoms

The goal of this observational case-control study is to learn how stressful experiences, dietary habits, and blood nutrient levels are associated with gastrointestinal symptoms and symptoms of depression and anxiety in adults aged 18 to 65 years. The study will also examine whether positive psychological resources, such as hope, optimism, resilience, and self-confidence, are related to these associations. The main questions this study aims to answer are: * Are stressful experiences in childhood and recent stressful life events associated with gastrointestinal symptoms and symptoms of depression and anxiety? * Are dietary habits and blood levels of selected nutrients associated with gastrointestinal and psychological symptoms? * Do psychological resources, such as hope, optimism, resilience, and self-confidence, influence the relationships among stress, nutrition, gastrointestinal symptoms, and psychological well-being? Researchers will compare 100 participants with gastrointestinal disorders and psychological symptoms or a history of stress with 100 control participants who do not have chronic gastrointestinal symptoms and have low levels of depression and anxiety symptoms. Participants will: * Complete questionnaires about stressful experiences, dietary habits, gastrointestinal symptoms, depression and anxiety symptoms, psychological resources, and quality of life. * Have gastrointestinal sounds recorded. * Allow blood remaining from routine clinical testing performed before endoscopy to be used to measure cholesterol, vitamin B6, and vitamin C levels. No additional blood draw will be required for this study. All study assessments will be completed once at enrollment. There will be no follow-up visits, and participants will not receive or be assigned to any treatment as part of this study.

Combined tDCS and Cognitive Neurorehabilitation in Post-Stroke Depression

This study evaluates a multimodal intervention pathway for affective and cognitive symptoms after ischemic stroke. Patients undergo an initial screening of depressive symptoms, cognitive function, and quality of life. Participants meeting the criteria for intervention are randomized to one of four groups: active transcranial direct current stimulation (tDCS), sham tDCS, online cognitive neurorehabilitation, or a combined intervention using active tDCS and online cognitive neurorehabilitation. Clinical outcomes include depressive symptoms, cognitive performance, and quality of life assessed longitudinally during follow-up.

Parenting-STAIR Modular for Military Fathers and OCONUS Families

The goal of this clinical trial is to learn if a family-based treatment called Parenting-STAIR-Modular (PSTAIR-M) can help military parents recover from trauma, strengthen emotion regulation skills, and improve parent-child relationships. Participants will be trauma-exposed active-duty Service Members (SM) or their spouses who screen positive for PSTD and/or depression, and one identified child (ages 2-10). The main questions it aims to answer are: 1) Does PSTAIR-M reduce parental PTSD and depression symptoms, lower parenting stress, and improve child behavior compared to treatment-as-usual?; and 2) Is PSTAIR-M feasible and acceptable when delivered to military families stationed overseas? Researchers will compare PSTAIR-M to treatment-as-usual (TAU) to see if PSTAIR-M leads to greater improvements in parental PTSD, depression, parenting stress, emotion regulation, child maltreatment risk, and child behavior than usual care. Participants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded.

Flywheel Resistance Training and Traditional Resistance Training in Older Women With Sedentary Behaviors

There are easily accessible and safe strategies, such as resistance training, that can contribute to reducing depressive symptoms and preserving physical and executive function in older women. Resistance training is defined as exercises performed either in water or on land, involving the use of a constant load or uniform weight, regardless of the training program. Various types of resistance training equipment are available, including free weights, pneumatic resistance machines, elastic bands, or even body weight. Specifically, eccentric muscle action occurs when the force applied to the muscle exceeds the momentary force produced by the muscle itself, resulting in the forced elongation of the muscle-tendon system during contraction. To date, evidence from randomized clinical trials has compared the effectiveness of aerobic, resistance, and Pilates exercises in reducing depressive symptoms and improving physical and executive function in older women. While experimental studies have demonstrated the efficacy of physical exercise, the effect of long-term eccentrically reinforced resistance training on depressive symptoms, physical function, and executive function in sedentary older women remains unclear. Therefore, this study aims to evaluate the safety and effect of eccentrically reinforced resistance exercise versus traditional resistance training on depressive symptoms, physical and executive function, quality of life, different manifestations of muscle strength, body composition, vital signs, abdominal circumference, fall risk, and fatigue symptoms in sedentary older women over a 9-month period.

The Oh Happy Day Class - Digital Connections (OHDC-DC): A Pilot Study

The goal of this clinical trial is to see if a mobile phone app can deliver depression treatment to African Americans who are depressed. The main question it aims to answer is if this treatment is effective in reducing symptoms of depression. Participants will attend six 90-minute weekly classes via an app on their phone, and will be asked to complete surveys every week. Participants can expect to be in the study for four months.

Mood and Thought Process Study

The primary objective for this project is to test whether affective executive functioning is a mechanism of action of mindfulness-based cognitive therapy and Wellness for Wellbeing. The main questions it aims to answer are: 1. Test the effect of MBCT vs. Wellness for Wellbeing on affective inhibition (i.e., emotionally valenced inhibition as measured via the affective Go/No Go task) using an RCT. 2. Test the effect of MBCT vs. Wellness for Wellbeing on (a) affective updating and (b) affective shifting. Outcomes will be measured with the affective n-Back and the affective Internal Switching Task, respectively. 3a) The investigators will examine whether depression symptom severity co-varies with change in affective executive functioning (i.e., affecting inhibition, shifting, and updating) over time. 3b) The investigators will examine whether compliance with treatment protocol (e.g., number of classes attended, amount of home practice) predicts endpoint executive functioning. Participants will complete surveys, interviews, and computer tasks, and will be randomized to either Mindfulness-Based Cognitive Therapy or Wellness for Wellbeing.

JAK Signaling in Depression and Cognition in Male Football Players

This study is being done to learn more about the role of inflammation in depressive and cognitive symptoms in patients with depression who have played at least 11 years of organized tackle football. This will be evaluated using a medication called baricitinib, which blocks one aspect of inflammation.

Efficacy of EMDR Versus CBT for Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study

Post-Traumatic Stress Disorder (PTSD) is commonly accompanied by symptoms of depression and anxiety. Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT) are evidence-based psychological treatments for PTSD, but there has been limited research on their feasibility, cultural applicability, and comparative effects in Pakistan. This study was conducted as a randomized controlled feasibility-pilot study before undertaking a larger definitive randomized controlled trial. The study was carried out in two main phases. In the first phase, selected diagnostic measures for PTSD, depression, and anxiety were translated into Urdu and evaluated for their psychometric and cross-language properties in a Pakistani clinical population. The measures included the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), Hamilton Depression Rating Scale (HDRS), and State-Trait Anxiety Inventory (STAI). The study also included cultural adaptation and feasibility assessment of the EMDR and trauma-focused CBT treatment protocols, together with assessment of treatment fidelity and therapist competence. In the randomized pilot phase, patients with PTSD and related depressive and anxiety symptoms were recruited from two rehabilitation centres in Peshawar, Pakistan. Forty eligible patients were randomly allocated in a 1:1 ratio to either EMDR (n=20) or CBT (n=20). Participants remained in their assigned treatment group. PTSD, depressive, and anxiety symptoms were assessed at baseline, during treatment at approximately six weeks, at the end of treatment at approximately 12 weeks, and at a two-month follow-up. Treatment was delivered by trained clinical psychologists using the selected EMDR and CBT protocols. The main purpose of this feasibility-pilot study was to determine whether the assessment procedures, culturally adapted treatment protocols, recruitment procedures, treatment delivery, and comparative evaluation of EMDR and CBT were feasible for a subsequent larger randomized controlled trial in Pakistan.

Effects of Digital Detox on Mental Health in Young Adults

The goal of this clinical trial is to learn whether a short, self-guided program for cutting down smartphone screen time can reduce symptoms of depression in young adults. It includes students in Oslo, Norway, who have applied for help at the student mental health service (SiO Mental Health). The main questions it aims to answer are: * Does a 2-week screen time reduction program reduce symptoms of depression? * Does it reduce symptoms of anxiety? * Can a simple, widely available phone app reduce screen time, and does the reduction last? Researchers will compare students who start the program right away with students who continue their usual care for 2 weeks and receive the same program afterwards. Participants are placed in one of the two groups by chance, like flipping a coin. Participants will: * Answer questionnaires about depression and anxiety symptoms at the start and again after 2 weeks * Upload screenshots of the Screen Time summary on their iPhone at the start, after 2 weeks, and after 12 weeks * Install an app that blocks the apps they find most distracting and keep it active for 2 weeks, if they are placed in the program group * Take part entirely online, with no clinic visits and no contact with the study team