Clinical Research Directory

CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention

This Phase II study is a continuation of the Phase I feasibility study where the investigators fully met and exceeded project aims to design, build, and test the usability and acceptability of an avatar-based system, Jaspr Health ("Jaspr"), for use by suicidal ED patients and medical personnel responsible for their care. Phase II includes a formative phase, during which the investigators will continue conducting usability and acceptability tests of new features, and a summative phase to conduct a clinical trial. SBIR Phase II project aims include: (1) Complete development of Jaspr, including readiness for electronic health record integration; (2) Cultivate and utilize the advisory board so that Jaspr is positioned to meet the needs of diverse healthcare systems and successful conduct of the proposed research; (3) Conduct usability/acceptability tests of new features with target end-users (suicidal patients, including those in the ED, medical providers) and key stakeholders (i.e., administrators); and (4) Conduct a randomized controlled trial (RCT; n=31) of suicidal ED patients comparing Jaspr (n=14) to Care-As-Usual (CAU; n=17). Participants were assessed at baseline while in the ED, and again at 7, 30, and 90 days. The investigators predicted that Jaspr participants will report a significantly greater decrease in suicidal behaviors and ED/hospital admissions, as well as significantly greater increases in use of behavioral coping skills, self-efficacy in coping with distress, and perceived helpfulness of patients' ED experience and satisfaction with the app. This study, however, was paused due to COVID after February, 2020 with a total of 31 participants recruited. The study later resumed at one site; however, because of COVID there were fewer admissions for suicidal behavior to the ED, only 7 participants were enrolled before the study ended recruitment in December, 2020 (RCT; n=7) (Jaspr; n=4) (CAU; n=3). The Telehealth clinical trial was conducted with suicidal outpatients to compare the Jaspr-At-Home companion mobile app (JAH; n=28) and CAU (in addition to crisis safety planning; n=26). Participants were assessed at baseline, 30- and 90-days after the initial session.

Rapid Personalization of Safety Plans for Psychiatrically Hospitalized Veterans at High-Risk for Suicide

Veterans psychiatrically hospitalized face significantly elevated suicide risk, particularly in the three months post-discharge. While Safety Planning is a required component of discharge planning, many safety plans lack personalization thereby reducing their effectiveness. The proposed intervention, Personalized Safety Plans (PSP), will be developed for rapid delivery on acute inpatient psychiatry units. PSP is a single-session intervention followed by twice monthly brief, personalized coaching sessions during the three-month high-risk discharge period. PSP will be iteratively refined and finalized in a case series (N = 15) then evaluated in a pilot randomized controlled trial (N = 96) comparing PSP to Safety Plans as Usual among psychiatrically hospitalized Veterans. Overall, the study aims to: 1) iteratively refine PSP; 2) examine PSP's preliminary effectiveness in reducing suicide ideation and increasing adaptive coping; 3) identify barriers and facilitators to implementation; and 4) develop a fidelity measure to support future personalization monitoring.

Targeting Emotion Dysregulation to Reduce Suicide in People With Psychosis

People with psychotic disorders are excluded from most suicide-focused clinical trials despite incredibly high rates of completed suicide, and interventions that have been tested for this population have shown limited impact on suicide. Emotion dysregulation is a significant suicidogenic factor that is understudied in people with psychotic disorders. The investigators propose to implement and evaluate an intervention targeting emotion dysregulation in people with psychotic disorders while employing rigorous statistical modeling and measurement techniques including Ecological Momentary Assessment, which will support future advanced research on suicide and suicide prevention for this high-risk group.

Expanding Access to Evidence-Based Suicide Risk Assessment and Intervention in a Crisis Stabilization Setting

The overarching goal of this project is to expand access to evidence-based suicide risk assessment, safety planning, and intervention among patients at elevated suicide risk by implementing Jaspr in a real-world psychiatric setting.

Cognitive Reappraisal Intervention for Suicide Prevention (CRISP 70+) for Suicidal Older Adults in a Swedish Geropsychiatric Setting

The overall aim of the project is to develop and test the feasibility and preliminary effect of a manualized psychosocial intervention Cognitive Reappraisal Intervention for Suicide Prevention (CRISP 70+) for older adults with suicidal behavior, an intervention that includes the optional participation of a close relative.

i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial

Approximately four thousand Canadians die by suicide every year, and suicide is the second leading cause of death in youth and young adults (15-34 years). Most people with depression experience thoughts of suicide and many will also plan and/or attempt suicide at some time in their life. There is an urgent need for new scalable treatments that can effectively reduce suicidality in people with depression. Cognitive behavioural therapy (CBT) reduces suicidal thoughts and behaviours, and can be delivered through the internet (i-CBT) making it more accessible and scalable. However, i-CBT has not been shown to rapidly reduce suicidal thoughts and behaviours (suicidality), such as within 24 hours. IV ketamine on the other hand has been shown to rapidly reduce thoughts of suicide, but not suicidal behaviours. Therefore, combining i-CBT with IV ketamine may be more effective reducing suicidality than i-CBT treatment with a control treatment. The investigators propose a 13-week, multi-site, study that looks at how combining i-CBT and IV ketamine treatment will affect suicidality in individuals with depression who have recently experienced suicidal thoughts and/or behaviours, but have not responded to previous treatment. All 76 participants will receive a weekly session of i-CBT for 13 weeks, but half will be randomly assigned to also receive six IV ketamine treatments or six IV midazolam treatments (control treatment) over the first initial 30 days. The investigators will measure changes in suicidal thoughts and behaviours before drug treatment and at the primary endpoint (i.e.,day 30), and after 3 months (i.e. Day 91) of the starting treatment.

Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression

Background: Major depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD. Objective: To test a study drug (HNK) in people with MDD. Eligibility: People aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254. Design: Participants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity. HNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule: They will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study. They will receive no drugs for 2 to 3 weeks. They will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study. One set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo. ...

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.

NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics

This study will adapt and evaluate an evidence-based suicide risk screening and follow-up program in two school-based health centers in West Virginia. The suicide screening program is titled the "NIMH Clinical Pathway" and provides tools and procedures for routinely screening adolescents for suicide risk screening, suicide risk assessment, safety planning, referral procedures, and follow-up care activities for adolescents receiving health services. The study will assess implementation outcomes, including suicide screening practices, identification of suicide risk, safety planning, and follow-up service delivery, as well as participant outcomes including suicidal ideation, depressive symptoms, satisfaction with services, suicidal behavior, safety plan utilization, and acute care utilization. Data collected across participating sites will be combined to evaluate the feasibility, acceptability, and preliminary effectiveness of the adapted Clinical Pathway. Protocol amendments resulted in consolidation of site-specific outcome measures into combined analyses across participating school-based health centers. The ClinicalTrials.gov record was updated to reflect the current protocol, study procedures, and planned statistical analyses.

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.

Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

The goal of this randomized pilot trial is to assess the feasibility of administering a combination of 100mg intramuscular (IM) ketamine and Crisis Response Plan (a short psychosocial intervention) for patients with acute suicidality in the context of the Emergency Department setting. This study will assess a combination of a pharmacologic intervention and a psychosocial one. The pharmacologic intervention is a one-time dose of 100mg ketamine delivered intramuscularly (IM) while the patient is in the ED. The psychosocial intervention under study is a brief, patient-centered therapy which takes, on average, 30 minutes to administer. Both interventions will be administered only once. The main questions this study aims to answer are: * Determine if 100mg of IM ketamine and Crisis Response Plan in combination results in greater short-term reductions in suicidal ideation in adult patients who report acutely elevated suicide risk during an ED visit. * Examine potential weight-based dose response differences in the reductions in suicidal ideation to determine if future treatment protocols with IM ketamine may benefit from weight-based dosing.

Peer Delivered Youth Suicide Prevention in Nepal

South Asia has the highest suicide rate in the world with important risk profile differences from high-income settings. Investigators will conduct formative research to co-design a package of brief interventions and implementation strategies to prevent youth-suicide and then test the package in a pilot feasibility hybrid type 2 cluster randomized controlled trial in Nepal. Potential health impacts may be substantial as results can be applied not only in similar South Asian primary healthcare contexts, but also in low-resource settings in the US and abroad, where the suicide burden remains high. Using experience-based co-design and equity-focused implementation frameworks, this study will assess the feasibility and acceptability of a Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP) integrated within existing mhGAP services in Nepal's decentralized primary healthcare system. This pilot trial will generate preliminary data to inform the design of a future fully powered effectiveness trial and potential scale-up of youth suicide prevention strategies.

Get Out of Your Head 2.0: Evaluation of an Online Prevention Campaign and Updated Website for Men

The primary objective of this study is to evaluate the perceptions and evaluations of men with suicidal thoughts, regarding the new "Get Out of Your Head" campaign and the updated website. The findings will inform potential adjustments to enhance the campaign and website as needed.

Pilot Study on Follow-Up of (Acutely) Suicidal Individuals From the Flemish Suicide Helpline

This pilot study aims to assess the acceptance, feasibility, and added value of follow-up calls at the suicide helpline, Zelfmoordlijn 1813, in Flanders (Belgium). It serves as a crucial preparatory step in the development and implementation process of the callback methodology at Zelfmoordlijn 1813.

Intensive Crisis Intervention

The study's purpose is to improve the clinical management of severe crises experienced by youth with psychiatric disorders by examining a brief, evidence-based alternative to inpatient psychiatric care.

Scaling Out S.A.F.E. Firearm Across Two Health Systems as a Universal Suicide Prevention Strategy (SCALE ASPIRE)

In this randomized controlled trial, researchers will assess the expansion of the S.A.F.E. Firearm program into adult primary care and women's health at two health systems in Michigan and Colorado that have previously implemented S.A.F.E. Firearm in pediatrics. S.A.F.E. Firearm involves a brief conversation between health care staff and patients about secure firearm storage and an offer of a free firearm cable lock. Researchers will test S.A.F.E. Firearm and a package of strategies intended to help health care staff incorporate the program into their practice. The strategies include: training, a prompt in the electronic health record, and facilitation, or tailored problem-solving support. The study seeks to answer the following questions: * How effective is S.A.F.E. Firearm at changing patients' firearm storage behavior? * How effective is the implementation strategy package at increasing delivery of the S.A.F.E. Firearm program? Some patients and health care staff will be invited to participate in surveys and/or interviews about their experiences with S.A.F.E. Firearm and the implementation strategy package.

Nudging Parental Actions for Youth Suicide Prevention

The goal of the study is to determine effectiveness of a behaviorally informed text messaging intervention to help parents increase safety practices and reduce their teens' access to lethal means following a suicide-related emergency department visit.

Evaluation of the Quality of Chat Conversations With the Suicide Helpline Zelfmoordlijn 1813

Suicide remains a serious public health issue in Flanders. Every day, nearly three people die by suicide, and many more attempt it or struggle with suicidal thoughts. The Zelfmoordlijn 1813 is a free and confidential helpline that offers support to people in crisis through phone, chat, and email. In 2024, volunteers had over 23,000 conversations, including nearly 3,000 via chat. This study, led by the Flemish Centre of Expertise in Suicide Prevention (VLESP) in collaboration with the Centre for Suicide Prevention (CPZ), aims to better understand how people experience the chat service of the Zelfmoordlijn 1813. While previous research has looked at the impact of phone conversations, little is known about how chat conversations affect suicidal thoughts and feelings. To explore this, people who contact the chat service will be invited to fill out a short questionnaire before and after their conversation. These questionnaires take about 3 minutes each and are completely voluntary. They ask about feelings like hopelessness, crisis, and perceived support, as well as satisfaction with the chat. The goal is to improve the quality of chat-based crisis support and ensure that people in emotional distress receive the best possible help. This research will help strengthen suicide prevention efforts in Flanders.

Mobile Intervention for Suicidal Thoughts

One of the factors that contributes to suicide risk is what is known as a "suicidal belief system." This belief system is made up of several cognitions that been associated with suicide risk among military personnel. Modification of these cognitions may reduce suicidal thoughts and behaviors. The study team has developed a brief mobile intervention entitled the Mobile Intervention for Suicidal Thoughts (MIST) that uses evidence-based interpretation bias modification techniques to reduce these suicide cognitions. The goal of this project is to is to conduct a pilot trial of the MIST intervention to evaluate whether it is feasible an acceptable as an adjunct treatment for Veterans with suicidal ideation.

Screening and Monitoring of Mental Health in Educational Settings: Programme for Detection, Psychoeducation and Self-help

Adolescence is a critical developmental stage during which many mental health problems first emerge. However, a large proportion of these issues go undetected and untreated. Globally, approximately one in seven adolescents experiences mental health difficulties, with increasing trends observed in recent years. Schools offer an important setting for early detection and intervention, yet existing programmes often lack structure or scalability. The MENTOR programme (MENtal Health Tracking, Outreach and Referral) was designed to identify adolescents under psychological distress in educational settings and offer tiered support including psychoeducation, self-help tools, and referral to mental health services when needed. This is a prospective, longitudinal, multicentre study that will be implemented in eight educational centres in Spain, including secondary schools, sixth-form colleges, and vocational training centres. Adolescents and young adults will be invited to participate voluntarily. At baseline and at each trimester, participants will complete validated mental health screening tools assessing common conditions such as anxiety, depression, and emotional dysregulation. Based on results, participants will be assigned to one of several support pathways: access to digital self-help materials, small-group interventions, or referral to school-based or external mental health professionals. Follow-up assessments will measure changes in symptomatology, engagement with self-care tools, and help-seeking behaviour. Quantitative data will be analysed to assess feasibility, adherence, and effectiveness of the intervention over time, and conduct a cost-effectiveness analysis This protocol aims to improve adolescent mental health through a school-based, digitally delivered screening and intervention programme. By evaluating feasibility and acceptance across eight educational centres, the study seeks to generate real-time data on prevalent mental health issues, promote awareness and self-care, and facilitate early professional intervention. If effective, the programme could support scalable, tiered prevention strategies in educational settings, contributing to reduced rates of anxiety, depression, suicidal ideation, eating disorders, and addictions. Its implementation may also improve resource allocation, reduce wait times, and inform future health policies for longitudinal mental health monitoring from childhood. Findings will contribute to the development of accessible, evidence-based models for adolescent mental health promotion and early intervention.

Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Open Trial

The primary aim of the present study is leverage existing infrastructure to develop novel technological features for a novel personalized smartphone intervention system, called the Mobile Application to Prevent Suicide (MAPS), and to establish feasibility, acceptability, safety, and estimate key parameters for secondary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).

Evaluation of a Telehealth Case Management Intervention to Prevent Suicide Among Soldiers Discharged From Psychiatric Hospitalization

This study evaluates the effectiveness of Pathfinding, a 6-month, remotely-delivered case management intervention designed to decrease suicidal behavior among active-duty Regular Army soldiers recently discharged from inpatient psychiatric treatment. Soldiers discharged from military treatment facilities across the U.S. will be identified and recruited to participate. Those who consent will be randomly assigned to receive either Treatment As Usual (TAU), which is the Army's standard post-discharge care, or TAU plus Pathfinding. Participants will complete a baseline assessment and follow-up assessments 6 months and 12 months later. The 6- and 12-month follow-up periods will also include examination of participants' electronic healthcare data and Army administrative data. The overall goals of the study are: (1) to evaluate whether Pathfinding decreases suicidal behaviors among soldiers transitioning from psychiatric hospitalization back to the community; and (2) to determine which discharged soldiers are most likely to benefit from the Pathfinding intervention versus TAU alone.

Caring Connections Youth Suicide Detection and Intervention Study

The goal of this pilot randomized control trial (RCT) is to test the feasibility of Caring Connections, a Culturally Adapted Linking Individuals Needing Care (CA-LINC) suicide prevention care coordination intervention for high-risk suicidal youth. This consumer-, community-, and theory-driven care coordination intervention is designed to reduce suicide ideation and behavior (SIB) by improving service engagement. Connections is a 90-day intervention that integrates engagement and follow-up strategies to assess/monitor suicide risk, facilitate service use referrals/linkages, develop/refine safety plans, and create villages of care. The intervention incorporates cultural promotive factors, empowerment, and motivational strategies aimed at supporting youth, enhancing strengths, promoting hope, improving family relationships, and reinforcing caring messages. Primary research questions include: Is Caring Connections feasible to use for suicidal high-risk youth? Does Caring Connections have the potential to reduce suicide ideation and behaviors among high-risk suicidal youth? For the pilot RCT, 80 youth participants ages 13-19 who meet the inclusion criteria will be randomly assigned to one of two conditions: Caring Connections (n=40) or Treatment as Usual (n=40). Additionally, investigators will enroll 80 caregivers of youth meeting inclusion criteria and 20 Mental Healthcare, Healthcare Providers, Community Stakeholders, and/or Care Coordinators with experience working with suicidal youth. Researchers will compare those receiving Caring Connections with treatment as usual to see if suicidal ideation and behaviors, and engagement.

THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers

Suicide is a major public health concern in the United States, with more than 1.4 million adults attempting suicide and nearly 50,000 adults dying by suicide each year. The launch of the national 3-digit 988 Suicide \& Crisis Lifeline in 2022 has strengthened the crisis care system by emphasizing the need for people in crisis to have someone to call, someone to respond, and somewhere to go. Community-based Crisis Stabilization Centers (CSCs) are an important part of the crisis care system, providing short-term crisis stabilization services and an alternative to Emergency Department care. However, suicide risk can remain high after discharge from CSCs, and no brief, effective, recovery-focused interventions are currently available for this setting. This study will evaluate the effectiveness of THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement) in CSCs. THRIVE is a recovery-focused intervention designed for adults receiving care for suicide risk . THRIVE includes one 60-minute psychotherapy group (focused on belonging, giving, meaningful living, and recovery) delivered during the CSC stay and up to six peer-led recovery coaching calls during the weeks following discharge. This multi-site Hybrid Type 1 randomized effectiveness-implementation trial will enroll 552 participants and compare care as usual (CAU) in CSCs to CAU plus THRIVE (CAU + THRIVE). The primary purpose of this study is to determine whether THRIVE reduces suicide risk events (SREs) following CSC discharge, including crisis care re-admissions, escalation to higher levels of care, suicide attempts, and suicide deaths. The study will also examine barriers and facilitators that may influence the adoption and implementation of THRIVE in community-based crisis settings.