Clinical Research Directory

Exploring The Effect of TikTok Trigger Warnings in a Clinical Sample of Youth at Risk of Suicide

Rates of suicide among Canadian youth have risen steadily over the past two decades, alongside rapid growth in social media use-especially TikTok. Our research shows that TikTok contains substantial suicide-related content that may pose risks to vulnerable young people by provoking distress or encouraging copycat behaviour. Many creators add trigger warnings (TWs) to flag upsetting material, yet their impact is unclear. Although research shows mixed effects of TWs among people with trauma histories, no studies have examined TWs in the context of suicide-related content. Our recent findings indicate that TWs are associated with reduced engagement suicide-related videos on TikTok-contrary to our hypothesis that they might increase engagement. Although we can only speculate, reduced engagement may reflect youth avoiding TW-labelled content, or other unknown factors. This study will examine how a clinical population of youth at risk of suicide emotionally and behaviourally respond to TWs on self-harm and suicide-related content. Findings will provide key evidence to inform public health recommendations aimed at protecting youth from harmful content online.

Virtual Reality Lethal Means Safety Training

The goal of this randomized clinical trial is to determine whether a virtual reality (VR) training program can help healthcare providers improve their skills in discussing suicide prevention and safe storage of firearms and medications with Veterans. The study will test whether VR training increases providers' self-efficacy, confidence, and comfort in conducting lethal means safety counseling, and whether it improves their intention to use these counseling practices in their clinical work. Researchers will compare healthcare providers who complete the VR training to those who complete a 2D video training to determine whether the VR approach is more effective. Participants will complete online surveys before and after the training and again three months later. They will be randomly assigned to one of two groups: VR training group: Participants use a VR headset to interact with a virtual Veteran patient in a simulated rural clinic and practice suicide prevention counseling skills; Video training group: Participants use the same headset to watch a \~10-minute 2D video depicting the lethal means safety counseling session. After the training, participants will also provide feedback about their experience, including how realistic and useful they found the training.

Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression

The goal of this clinical trial is to learn if a multi-layered digital and pharmacogenomic intervention works to prevent suicide re-attempts in adults with depression. It will also evaluate the safety and effectiveness of continuous digital monitoring, digital safety plans, and precision medication management. The main questions it aims to answer are: * Does the multi-layered intervention lower the rate of suicide re-attempts over a 6-month period compared to standard care? * How do digital tools and genetic-guided prescribing affect depressive symptom severity and treatment-emergent adverse drug reactions? Researchers will compare three groups: participants receiving standard care plus digital monitoring, participants receiving standard care plus digital monitoring and an interactive digital safety plan, and participants receiving standard care plus digital monitoring, a digital safety plan, and pharmacogenetic-guided care. Participants will: * Install study smartphone applications (MeMind and eB2 Mindcare) to track daily mood, stress, and activity patterns through active and passive digital phenotyping. * Authorize historical digital trace extraction via Google Takeout and provide baseline blood samples for genetic, multi-omics, and pharmacokinetic profiling. * Complete regular clinical checkups and questionnaire assessments at baseline and at weeks 4, 8, 12, and 24.

Suicide Prevention Integration Into Task-shifted Mental Health Interventions

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

IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania

In this project, the investigators will conduct a clinical trial to test the effectiveness and implementation of IDEAS for Hope, a 3-session telehealth counseling intervention delivered by nurses, to reduce suicidality and improve HIV care engagement among PLWH in Tanzania. The investigators will also examine mechanisms of change and implementation outcomes of the intervention, including cost-effectiveness, to disseminate a feasible, scalable, and sustainable intervention and implementation package to address a critical mental health comorbidity in HIV care.

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.

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.

SAFEGUARD Level Up Study

This project will evaluate the effectiveness of Level Up: Boost Your Life Skills ("Level Up"), a strengths based, military-specific life skills training program. The goal is to determine whether Level Up can decrease suicidal-related behaviors (SRBs) and other harmful behaviors, improve mental health, enhance job performance, and reduce early military separation. The Level Up program components will be made available to participants through an online platform or mobile app that can be downloaded onto their personal mobile devices. These training materials will help Soldiers learn and practice skills. The Level Up program will also involve personalized messages from a Level Up trainer and virtual booster sessions. Active duty Soldiers who are currently stationed at Fort Hood, Texas and are members of a participating platoon will be randomized to receive either Level Up or Training as Usual (TAU). Participants will complete baseline and follow up surveys 1, 3, and 6 months post-baseline.

Caring Contacts Via Text Message for Suicidal Adolescents After Emergency Department Discharge

The goal of this pilot clinical trial is to learn if Caring Contacts (brief, hopeful, supportive text messages) can be delivered to adolescents with suicidal thoughts or behaviors after discharge from the emergency department, and to understand if adolescents find it acceptable to receive Caring Contacts. Researchers will also begin to explore how suicidal thoughts and behaviors change over time among participants who receive Caring Contacts along with treatment as usual, compared to participants who only receive treatment as usual. All participants will be invited to answer survey questions when they first enroll in the study and 1, 3, 6, and 12 months after their emergency department visit. Some participants will receive Caring Contacts (brief, hopeful, supportive text messages) after their emergency department visit. Some participants will be invited to complete an interview about their experiences receiving Caring Contacts.

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.

Esketamine Versus Crisis Response Planning Versus Enhanced Treatment as Usual for Suicide Prevention: A Pragmatic Randomized Trial in a Brazilian Municipality (SAVE)

The SAVE study will test whether a single esketamine infusion or a single Crisis Response Planning session, each added to enhanced treatment as usual, reduces future suicide-related events compared with enhanced treatment as usual alone. The study takes place in the public emergency care network of Indaiatuba, São Paulo, Brazil, and includes adolescents and adults aged 14 years or older who have attempted suicide within the previous 30 days or currently have severe suicidal thoughts with intent to act. The main questions are whether either intervention reduces suicide-related events over 12 months and whether the interventions improve suicidal thoughts, depression, anxiety, sleep, well-being, hopelessness, and quality of life. Researchers will also evaluate acceptability, feasibility, use of health services, and costs. Anticipated total enrollment is 478 participants: 10 participants in a separate pilot cohort and 468 in the main cohort used to test the study hypotheses. The main cohort will be assigned by chance, in equal numbers of 156 participants, to one of three groups: 1. Esketamine plus enhanced treatment as usual: one intravenous infusion of esketamine at 0.375 mg/kg over 40 minutes, with medical supervision and monitoring of heart rhythm, blood pressure, and oxygen levels. Participants remain under clinical observation, with discharge after 24 hours if clinically stable. 2. Crisis Response Planning plus enhanced treatment as usual: one 20-to-45-minute session with a trained clinician to develop a personalized plan covering warning signs, coping strategies, reasons for living, support contacts, and emergency resources. Participants receive a printed plan and a digital copy. 3. Enhanced treatment as usual alone: early outpatient psychiatric consultation, arranged to take place within seven days of randomization, plus lethal means safety counseling to reduce access to potentially lethal means. Both components are offered to participants in all three groups, alongside routine emergency care. The study records whether each component was delivered; booking a consultation alone does not count as receiving it. Participants will complete assessments at enrollment, 24 hours, seven days, and weeks 2, 4, 8, 16, 24, 32, 40, and 52. Blood samples will be collected at enrollment for exploratory analyses of biological factors that may be associated with treatment response. Safety monitoring and contact to identify new events will continue throughout follow-up. Participants will also use a smartphone application to answer brief questions about their mood, thoughts, and experiences during three periods of 30 consecutive days, beginning at enrollment and at calendar months 4 and 8. There will be three prompts each day: two at fixed times, 09:00 and 21:00, and one at a randomly selected time between 10:00 and 20:00, using local time in Indaiatuba. This represents 90 assessment days and 270 scheduled prompts over the study. The study team will contact participants within 24 hours of a safety alert through a dedicated study mobile phone with WhatsApp. Participants will be instructed to seek emergency care immediately when needed rather than wait for a study response. The main outcome is the time to the first qualifying event: a suicide attempt, including an attempt stopped by the person or interrupted by someone else; a psychiatric admission to prevent suicide; death by suicide; or self-injury requiring emergency department care. An external adjudicator who does not know the assigned treatment will review suspected events and determine whether they meet the study definition. Outcome assessors will also be unaware of treatment allocation. Participants who experience a qualifying event may be offered rescue treatment combining esketamine and Crisis Response Planning, depending on clinical eligibility and safety. They will remain in follow-up and in analyses according to their original randomized group. The first qualifying event will still count in the main analysis. Pilot data will be described separately and will not be included in confirmatory efficacy analyses.

Suicide Prevention After Community Care Discharge

The study is of high importance to Veterans' health because it will study a suicide prevention intervention in a Veteran population that is at high risk of suicide but has not been a specific focus of the Veteran Affairs' (VA's) suicide prevention efforts. Specifically, a growing number of Veterans are now receiving acute mental health treatment in VA-purchased settings (commonly referred to as Community Care). While these Veterans are at high risk of suicide after discharge, very little is known about how to prevent suicide in these Veterans. This study will directly address this problem by looking at whether a promising suicide prevention strategy called the VA Brief Intervention and Contact Program (VA BIC) can decrease the risk of suicide in Veterans after they are discharged from a non-VA mental health treatment setting. The proposed research is highly pertinent to the VA's top clinical priority-to prevent suicide in Veterans.

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.

Youth Suicide Risk Factors, Reduction of Suicide Risk Factor in Youth People

The YOU-SURF project is at the forefront of youth suicide prevention, with the goal of integrating multimodal clinical and neurobiological data to comprehensively identify risk factors and the most effective intervention strategies. Suicide is one of the leading causes of death among young people, with particularly alarming incidence rates during adolescence and early adulthood. Suicidal risk is a complex phenomenon, determined by a multiplicity of clinical, environmental, and biological factors. Emerging evidence suggests that information derived from neuroimaging, genetics, and the microbiome may also play a significant role. However, studies conducted to date have not yet adopted a truly multimodal approach that jointly integrates these dimensions in the identification of risk factors for suicide in youth. The YOU-SURF project aims to fill this critical gap. YOU-SURF will also pioneer the use of deep transcranial magnetic stimulation (dTMS), an innovative neuromodulation technique, whose effectiveness in reducing suicidal risk in young people will be assessed within a longitudinal design. Although some preliminary evidence suggests a potential benefit of neuromodulation treatments in this population, the specific effects of dTMS on suicidal risk in youth remain largely unexplored. Furthermore, there is a significant lack of knowledge regarding predictors of response to dTMS in young individuals at risk for self-harming behaviors. The specific objectives of the project are as follows: 1. To identify youth suicide risk factors through the integration of clinical, environmental, neuroimaging, genetic, and microbiome data; 2. To longitudinally evaluate the effectiveness of dTMS in the treatment of young people at risk of suicide; 3. To develop a predictive model based on machine learning techniques, grounded in multimodal data, to estimate the individual response to dTMS in this population. The results of the project will provide a solid scientific basis for the development of personalized prevention and treatment interventions, improving clinical effectiveness and resource allocation in youth mental health services.

Suicide Safety Planning

The goal of this clinical trial is to learn the best way to provide suicide prevention care to adults receiving outpatient mental health care. The study compares two approaches based on the Zero Suicide Framework: Local Care Continuity and Centralized Care Navigation. The main questions the study aims to answer are: * Does adding support from a centralized telehealth care navigation team reduce suicide attempts compared with providing additional tools and support to local mental health clinicians? * Does the centralized approach help more patients receive recommended suicide prevention care, including safety planning, and connect with follow-up mental health treatment? * How do patients experience the two approaches, including their ability to cope with difficult situations and their experiences with their mental health care? Researchers will compare Local Care Continuity, in which suicide prevention care is delivered by patients' local mental health clinicians with additional implementation support, with Centralized Care Navigation, which adds support from a centralized telehealth team of clinicians and care navigators. The researchers expect that Centralized Care Navigation will result in better suicide prevention care, greater connection to follow-up treatment, and fewer suicide attempts than Local Care Continuity.

Attempted Suicide Intervention Treatment and Prevention (SAMIT Program)

Suicide has become a first-order public health concern after the negative impact of coronavirus disease 2019 (COVID-19) on the mental health of the general population. Few studies have analyzed the effects of early psychotherapeutic interventions on subjects who have attempted suicide, and even fewer focus on those hospitalized in nonpsychiatric units after a medically serious suicide attempt (MSSA). The most important risk factor for attempting suicide is having made a previous suicide attempt. Subjects are also at higher risk the first year after the attempt. The main aim of this study is to evaluate the effectiveness of individual psychological treatment with patients hospitalized after a MSSA. The secondary objectives are: 1) acknowledge the evolution of the incidence of MSSA hospitalized during the pandemic; 2) analyze the impact of the psychological intervention using biological, psychosocial, and clinical variables. An experimental, controlled, and randomized trial will be conducted with patients older than 16 admitted to two general hospitals. The case group will receive an 8- session of individual psychotherapy while the control group received treatment as usual. Longitudinal assessment will be conducted at baseline, post-treatment, and 3, 6, and 12 months after. The main outcome variable will be re-attempting suicide during the follow-up.

Pilot Testing Suicide Risk Prediction Algorithms in Primary Care

The goal of this pilot study is to learn whether the use of suicide risk prediction algorithms in primary care can help identify people who may benefit from extra mental health monitoring. Specifically, this study aims to measure how use of the suicide risk prediction algorithm to prompt extra mental health monitoring among adult primary care patients impacts proportions of patients identified at risk of suicide and engaged in safety planning. Secondarily, we plan to measure proportions of patients identified at risk of suicide via mental health monitoring (irrespective of engagement in safety planning).

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?

Retreat-Based Program for Violence-Exposed Women Veterans

Given their elevated risk for suicide and barriers to engaging in VHA healthcare, violence-exposed women Veterans represent a specialized population for which expansions to current VHA programming are needed. This pilot study is to assess the feasibility, acceptability, and preliminary efficacy of the Growth, Resilience, Insight, and Togetherness (GRIT), a therapeutic retreat program developed with and for Veteran women, to improve social functioning as a potential upstream suicide prevention strategy in comparison to a self-guided program. If found acceptable and feasible, data gathered will inform subsequent program development and identify avenues for further research on use of retreats grounded in Whole Health principles for additional subpopulations of women Veterans and/or other high-risk populations that may benefit.

Development of a Digital Acceptance and Commitment Therapy Intervention for Suicide Prevention in Adults Through Co-design

Suicide is a major public health concern and there is a need for accessible and scalable interventions to support individuals experiencing suicidal thoughts. The aim of this study is to develop a digital Acceptance and Commitment Therapy (ACT) intervention for suicide prevention in Chinese adults through co-design. The study will involve literature review, interviews, and co-design activities to identify user needs, preferences, and contextual factors, and to develop the intervention. Following intervention development, a pilot study will be conducted to evaluate the feasibility, usability, acceptability, and user engagement of the intervention. Findings from this study will inform further refinement of the intervention and future evaluation studies.

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.

Psychoeducational Course for Suicide Prevention

The plan is to include patients with a history of increased risk of suicide. In the aftermath of an episode of imminent suicide risk, patients will receive a psychoeducational course that entails information on different aspects of suicide-related topics, identifying triggers and detecting early warning signals for increased suicide risk. The course culminates in working on completing a individual safety plan to prevent an future increase in suicide risk. The course will incorporate both patients and their next of kin. The psychoeducational course will be compared to a control group where the patients receive one individual session with focus on a safety plan to evaluate the intervention. Both groups will receive treatment as usual (TAU) during both the acute phase and follow-up. The study will be conducted as a randomized controlled trial.

HAVEN-Connect Youth Suicide Prevention

HAVEN=CONNECT is a comprehensive depression and suicide prevention intervention that is designed to be integrated into predominantly Black churches, a strategically ideal location for mental health intervention for Black youth. HAVEN=CONNECT has three components: (1) Church Community Engagement: an interactive process of introducing the program to key church leaders and stakeholder groups. (2) Faith-Based Curriculum: educational overview for pastors, other ministerial staff and youth lay leaders on how to integrate the program into the church using communication mediums that have cultural and religious relevance in the Black Church context. (3) Youth-Connect Intervention: The goals of this project are to test the impact of HAVEN=CONNECT (HAVEN) on key intervention targets, hypothesized mediators, and build a research-informed implementation strategy for future large-scale testing.

Adapting a Brief Suicide Intervention for Pediatric Primary Care: Enhancing Uptake and Impact

Suicide is a leading cause of death among adolescents in the United States and improving access to high quality just-in-time suicide interventions to reduce risk has important public health implications. Integrating such interventions into routinely accessed settings, such as pediatric primary care, holds promise; however, many clinicians in these settings fail to adequately screen or intervene in youth suicidal thoughts and behaviors, representing a key barrier to reducing suicide. The proposed study is a pre-post quasi-experimental pilot feasibility and preliminary efficacy trial of a suicide prevention intervention informed by evidence based interventions including the SAFETY-Acute suicide prevention intervention implemented in 3 pediatric primary care clinics.