Clinical Research Directory

Brief Cognitive Behavioral Therapy for People With Physical Disabilities

The purpose of this study is to examine the effectiveness of a psychotherapy (non-medication) treatment, Brief Cognitive Behavioral Therapy for Suicide Prevention, in reducing suicide ideation and attempts for people with physical disabilities.

Wayne State Warriors Marijuana Clinical Research Program: Cannabinoid Adjunct to Prolonged Exposure & Recovery

The overall strategy is to recruit veterans with PTSD who report minimal current cannabis use but are interested in or considering therapeutic cannabis to manage mental health symptoms (anxiety, depression, PTSD and/or suicidality). The information gained from this study could lead to the development of new treatments for persons who suffer from post-traumatic stress disorder and maintain better mental health.

Mobile Technology to Reduce Teen Substance Misuse

The goal of this study is to test the newly expanded WisePath for Teens (WPT) for substance use app, a direct-to-consumer paired mobile phone app for iOS and Android platforms that supports parents/guardians in delivering evidence-based techniques to reduce youth substance abuse and co-occurring mental health problems. This project will expand WPT for use with a general population of teens with problematic substance use and their parents to reduce substance abuse, its harmful effects, opioid overdoses, and progression to substance use disorders, as well as other behavioral health problems that are exacerbated by substance abuse and/or interfere with substance abuse treatment.

Promoting Community Conversations About Research to End Native Youth Suicide in Rural Alaska

This intervention study measures the outcomes of the PC CARES (Promoting Community Conversations about Research to End Suicide) project implemented in remote rural Alaskan villages. Researchers worked with local service providers and other partners to recruit facilitators who were trained to implement the 5-session PC CARES curriculum. The study will compare pre-post data from intervention participants to non-participants, and will analyze social networks related to suicide prevention behavior in each village.

Comprehensive Adaptive Multisite Prevention of University Student Suicide

Suicide is the 2nd leading cause of death among college students and suicidal ideation and suicide-related behaviors are a frequent presenting problem at college counseling centers (CCCs), which are overburdened. Studies show that some students respond rapidly to treatment, whereas others require considerably more resources. Evidence-based adaptive treatment strategies (ATSs) are needed to address this heterogeneity in responsivity and complexity. ATSs individualize treatment via decision rules specifying how the type and intensity of an intervention can be sequenced based on risk factors, response, or compliance. The purpose of this multisite study is to investigate the effectiveness of four adaptive treatment strategies (ATSs) to treat college students who report suicidal ideation when first seeking services at their college counseling center This multisite study will enroll moderately to severely suicidal college students in the "emerging adulthood" phase (ages 18-25) seeking services at CCCs. This Sequential Multi-Assignment Randomized Trial (SMART) will have two stages of intervention. In Stage 1, 700 participants from four CCCs will be randomized to 4-8 weeks of: 1) a suicide-focused treatment - Collaborative Assessment and Management of Suicidality (CAMS) or 2) Treatment as Usual (TAU). Sufficient responders to either intervention will discontinue services/be stepped down. Non-responders will be re-randomized to one of two Stage 2 higher intensity/dosage intervention options for an additional 4-16 weeks: 1) CAMS (either continued or administered for the first time) or 2) Comprehensive Dialectical Behavior Therapy (DBT), which includes individual therapy, skills group, and phone/text coaching for the clients and peer consultation for the counselors.

Suicide Specific Rumination in Veterans

Few treatments target core features of suicidal thoughts and behaviors in Veterans. Real-time functional magnetic resonance imaging neurofeedback can provide information regarding brain activation associated with suicide-specific rumination, defined as a "repetitive mental fixation on one's suicidal thoughts and intentions." The goal of this feasibility study is for Veterans to learn strategies for modulating activity within brain regions that have been demonstrated to contribute to the maintenance of rumination, as they receive neurofeedback feedback signals from the brain.

Mental Health in Primary Care

The goal of this study is to evaluate in an effectiveness-implementation type I hybrid trial, an enhanced version of eHealth Familias Unidas for reducing depressive, anxious symptoms and suicide behavior in Hispanic youth. The study will use a randomized rollout design with 18 pediatric primary care clinics in the South Florida area.

Pilot Study of Health System/Community Partnership for Enhanced Outreach to Prevent Suicide Attempts

The goal of this clinical trial is to test an enhanced outreach intervention (EOI) delivered by Samaritans of Boston (a community organization that provides support during mental health crises) for people after they leave an emergency department (ED) visit for suicidal thoughts. The main questions the trial aims to answer are: * Is the EOI feasible and acceptable? * Can the EOI be delivered with fidelity by Samaritans staff? Participants will: * Receive outreach (by call or text) once per week for 12 weeks after ED visit. During these conversations, Samaritans staff will ask participants questions about their suicidal thoughts and behaviors, develop and review a list of coping skills to use if they have suicidal thoughts, and discuss plans for receiving mental health care. * Receive caring messages from Samaritans staff at least once per week. * Be asked to complete monthly self-report questionnaires, and participate in a phone interview with study staff at the end of the study.

Integrated Suicide & Trauma Therapy for Suicide Risk

The investigators have developed a novel suicide intervention, Integrated Suicide and Trauma Therapy (ISTT). ISTT combines Brief-Skills for Safer Living (Brief-SfSL)-a promising method to enhance coping skills and reduce suicidality-with a trauma therapy component to alleviate the specific impacts of childhood trauma on suicide risk. The aim of this pilot is to test 12-weeks of ISTT to alleviate suicide risk among individuals with a history of childhood trauma and current suicidality.

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.

Optimizing a Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents

Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning. The BRITE suicide safety planning app was developed on evidence-based principles and has undergone rigorous formative development and effectiveness evaluations. However, to optimize its functionality, commercial viability, and scale its implementation, issues related to user engagement need to be addressed. This 4-week Micro-Randomized Trial (MRT) will optimize specific components of ViraBrite, an augmented version of the BRITE suicide safety planning app that integrates automated algorithms (i.e., just in time adaptive intervention features) to facilitate increased engagement with coping skills and pushes safety planning materials to users at periods of high risk (i.e., increases in emotional distress).

A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents

Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning. The BRITE suicide safety planning app was developed on evidence-based principles and has undergone rigorous formative development and effectiveness evaluations. However, to optimize its functionality, commercial viability, and scale its implementation, issues related to user engagement needed to be addressed. This 3 month Pragmatic Randomized Trial will evaluate the impact of the ViraSafe app-an enhanced version of the BRITE suicide safety planning app-on improving engagement with coping skills and safety planning among suicidal adolescents by comparing its intervention components to those of the original BRITE app.

Effects of Psychiatric Admissions on Self-harm and Suicide in People With Borderline Personality Disorder

The current study aims to evaluate the impact of long (\>5 days) and/or compulsory psychiatric inpatient care on subsequent healthcare utilization for self-harm and suicide in people with borderline personality disorder, a condition characterized by frequent self-harm. The basis for this study is the diversity of clinical practices across Swedish regions. By categorizing clinics based on their practices with respect to long and/or compulsory psychiatric inpatient care, it is possible to explore the impact of these practices on subsequent somatic and psychiatric healthcare, including emergency care due to self-harm as well as on completed suicides. All psychiatric clinics across Sweden authorized to administer compulsory care for adults, totalling 78 clinics will be included. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022). Data collection will involve the utilization of the national registers to capture outcome measures and account for confounding factors. The participants will be ranked based on a composite variable, which includes the average number of days spent in inpatient compulsory care and other psychiatric inpatient care exceeding 5 days, among individuals diagnosed with BPD. The top quartile of participants will be compared with the bottom quartile.

Warrior CARE: Cannabis Behavioral Health

This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.

Brief Skills for Safer Living (Brief-SfSL)

The goal of this project is to assess the efficacy of Brief-Skills for Safer Living (Brief-SfSL) in a randomized control trial. The investigators will be testing 150 participants Canada-wide, half of which will be randomized to receive Brief-SfSL (B-TAU) and the other half will be randomized to receive Brief-SfSL after a 3 month waitlist (WL-TAU). The main questions this study seeks to answer are: * Is B-TAU more efficacious than WL-TAU for reducing suicidal thoughts at 3 months? * Is B-TAU more efficacious than WL-TAU at 3 months for reducing depression severity, anxiety, and anhedonia? * Is B-TAU more efficacious than WL-TAU at 3 months for improving social connectedness, emotional regulation, functioning (work, life, social), executive control and social problem-solving? * Are adverse events equivalent between B-TAU and WL-TAU at 3 months?

A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents

Suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. To address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in The Bronx, New York. In collaboration with community stakeholders, suicide recovery narratives, featuring adolescents' experiences related to recovery from suicidal thoughts will be developed. A smartphone ecological momentary assessment (EMA) app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents.

Safety Planning Intervention Telehealth Service Model in Emergency Departments

The purpose of this study is to evaluate the effectiveness and implementation of a suicide prevention strategy delivered via telehealth in Emergency Departments. We will compare implementation of the Safety Planning Intervention plus follow-up calls (SPI+) delivered by Emergency Department (ED) staff to SPI+ delivered via ED referral to an off-site Suicide Prevention Consultation Center (SPCC).

Hand in Hand, We Rise (Xie Shou Gong Jin)

This study aims to conduct a cluster randomized controlled trial to assess the feasibility of implementing the "Hand in Hand, We Rise" (Xie Shou Gong Jin) multi-stakeholder collaborative school-based suicide prevention program in rural public junior high schools. Six schools will be randomly assigned in a 1:1 ratio to either the intervention group or the control group; the intervention group will simultaneously implement the "Youth Strengths \& Skills Curriculum (YSSC)" curriculum for students, "Life Gatekeeper" training for teachers, and mental health information dissemination for caregivers. The primary objectives are to evaluate recruitment, retention, adherence, implementation fidelity, acceptability, and safety within real-world school settings, and to preliminarily estimate changes in indicators such as suicidal ideation, depression, anxiety, loneliness, help-seeking attitudes, mental health stigma, self-esteem, school climate, and bullying. The findings will provide parameters and an implementation basis for a subsequent large-scale, multi-school cluster randomized controlled trial.

Implementing A Secure Firearm Storage Program in Illinois Health Centers in Partnership With AllianceChicago and the Illinois Primary Health Care Association (COMMUNITY ASPIRE)

This randomized controlled trial will take place in up to 15 community health centers across the state of Illinois. Researchers will be studying S.A.F.E. Firearm, a program that aims to increase secure storage of firearms in homes with children. Specifically, S.A.F.E. Firearm includes a brief conversation between pediatric clinicians and parents/guardians about secure firearm storage and an offer of a free cable firearm lock within the well-child visit. Researchers will also study a package of strategies to help pediatric clinics incorporate this new practice. The strategies include training for clinic personnel and facilitation, or tailored problem-solving support. The questions the study aims to answer are: * How effective is the package of strategies at helping pediatric clinics implement this new practice? * How effective is the S.A.F.E. Firearm program at changing parents', caregivers' and guardians' (hereafter, "parents") firearm storage behavior? Some parents will be invited to complete a brief survey after their visit about their experiences receiving S.A.F.E. Firearm. Some community health center personnel will also be invited to complete an interview about their experiences with S.A.F.E. Firearm and the package of strategies.

Study About Group and Phone Follow-Up After a Crisis

Crisis stabilization centers (CSCs) provide a less costly and more comfortable alternative to Emergency Department care for individuals with suicidal crises. With demand for crisis alternatives growing, effective interventions that fit the unique workflows and workforce of CSCs are needed to realize their life-saving potential. To address this need, the investigators will adapt, and pilot test the effectiveness of an interpersonally enhanced recovery and follow-up intervention delivered during and after admissions acute suicidal crises.

Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care

This study is being completed to examine different combinations of technology-augmented strategies to identify an effective Adaptive intervention (AI) addressing post-discharge suicide risk with high implementation potential.

Veterans Coordinated Community Care (3C) Study

Veterans Coordinated Community Care (3C) Study will recruit 850 Veterans at risk for suicide post inpatient hospitalization. Each participant will be randomly assigned to treatment as usual (TAU) or TAU plus the Coping Long Term with Active Suicide Program (CLASP), with follow-up for 6 months after discharge. Outcomes include suicide-related behaviors (including deaths due to suicide, opioid overdose, or other substance-related accidents; and nonfatal suicide attempts) and suicidal ideation and functioning.

Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics

This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive episode (MDE) or borderline personality disorder (BPD).

Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents

This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.