Clinical Research Directory

A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior

This study aims to evaluate the acceptability, safety, and efficacy of a smartphone-delivered intervention called Therapeutic Evaluative Conditioning for Suicide (TEC-S) in reducing suicidal thoughts and behaviors (STB) among adults with recent and frequent suicide ideation.

Inhaled DMT for Major Depressive Disorder

This Phase 2b, randomized, double-blind, active-controlled clinical trial will evaluate the efficacy and safety of inhaled N,N-dimethyltryptamine (DMT) in adults with Major Depressive Disorder (MDD). The study will test whether inhaled DMT can rapidly reduce depressive symptoms and suicide risk compared with a low-dose active comparator. A total of 140 participants will be randomized 1:1 to receive either 15 mg followed 1 hour later by 60 mg of inhaled DMT, or 1 mg followed 1 hour later by 4 mg of inhaled DMT. Participants who do not achieve remission at Day 7 will enter an open-label extension and receive a high-dose DMT session on Day 14 (±3 days). All participants will be followed for up to 12 months to evaluate the durability of response, safety, functioning, and quality of life.

Sleep Treatment for Teens (RCT Phase)

The purpose of this research study is to compare (vs. treatment as usual) a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia during the high-risk post-hospitalization period. Suicide is the 2nd leading cause of death among adolescents. Sleep problems, such as insomnia symptoms-the most common sleep problem in youth-may be a particularly promising treatment target to reduce suicide risk in adolescents. The investigators propose to test the feasibility, acceptability, and effectiveness of dCBT-I in a two-site (Rutgers and Old Dominion University) pilot study trial. Adolescents, 14-18 years-old, recently hospitalized for suicide risk with co-occurring insomnia (n=80, 50% at each site), will receive either dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU) or TAU alone. Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.

A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness

Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.

Neural Correlates of Suicidal Behavior in Youth

This study, titled "Neural Correlates of Suicidal Behavior in Youth: a Pre and Post CAMS Therapy Neuroimaging Study," aims to better understand the brain mechanisms underlying suicidal thoughts and behaviors in adolescents and young adults (ages 14-24). Suicide is a leading cause of death in this population, and current clinical approaches often fail to accurately predict or prevent suicidal behavior. This study seeks to identify objective neurobiological markers associated with suicide risk and treatment response. Participants will be divided into three groups: (1) high-risk individuals recently hospitalized following a suicide attempt, (2) medium-risk individuals with chronic suicidal ideation but no attempts, and (3) low-risk healthy controls. All participants will undergo advanced neuroimaging, including magnetoencephalography (MEG) and magnetic resonance imaging (MRI), along with comprehensive psychiatric assessments. The study focuses on brain regions and networks implicated in suicidality, including the anterior cingulate cortex and salience network, as well as neurochemical markers such as glutamate. It also examines electrophysiological activity and functional connectivity patterns associated with suicidal thoughts and behaviors. High-risk participants will receive an evidence-based psychotherapy called the Collaborative Assessment and Management of Suicidality (CAMS). This therapeutic approach emphasizes collaboration between patient and clinician to identify and address the underlying drivers of suicidal thoughts, with a focus on increasing hope and reducing psychological distress. Neuroimaging and clinical assessments will be repeated after completion of CAMS to evaluate treatment-related changes. The study's primary goals are to: * Identify neural and electrophysiological correlates of suicide risk. * Distinguish biological differences between individuals with suicidal ideation and those who have attempted suicide. * Determine how CAMS therapy affects brain function and neurochemistry. By integrating clinical and neurobiological data, this research aims to improve understanding of suicidality, enhance risk prediction, and inform more effective, personalized interventions for at-risk youth.

Walk With Me (WWM) for Perinatal Grief

The goal of this clinical trial is to learn if the Along With Me web-based intervention works to decrease posttraumatic stress symptoms and suicidal ideation among bereaved parents following pregnancy and early infant loss. It will also learn whether peer guides provide additional improvements on these outcomes. The main questions it aims to answer are: • Do people who receive Along With Me or Along With Me plus a Peer Guide compared to services as usual have lower posttraumatic stress symptoms and suicidal ideation than those who do not receive the intervention? Researchers will compare Along With Me and Along With Me plus a Peer Guide to services as usual (referrals made in the hospital setting) to see if Along With Me works to prevent and address posttraumatic stress symptoms and suicidal ideation. Participants will: * Receive access to a mobile app with approximately 10 therapeutic modules about how to manage grief and other symptoms. * Receive check-ins with a Peer Guide (in the Peer Guide condition only)

Sleep Treatment for Teens

The purpose of this research study is to test a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia during the high-risk post-hospitalization period. Suicide is the 2nd leading cause of death among adolescents. Sleep problems, such as insomnia symptoms-the most common sleep problem in youth-may be a particularly promising treatment target to reduce suicide risk in adolescents. The investigators propose to test the feasibility, acceptability, and effectiveness of dCBT-I in a two-site (Rutgers and Old Dominion University) pilot study trial. Adolescents, 14-18 years-old, recently hospitalized for suicide risk with co-occurring insomnia (n=20 pilot, 50% at each site), will receive dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU). Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.

Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation

The purpose of this study is to gather information regarding the use of a new type of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) for suicidal ideation in adolescents with Major Depressive Disorder (MDD). The investigators hope to learn if this TMS treatment improves suicidal ideation over 10 days and clinical outcomes over 1 year of follow-up.

Development and Testing of imHere4U: A Digital Suicide Prevention Intervention for Cyberbullied Adolescents

The objective of this study is to test the feasibility and preliminary efficacy of Flourish (formerly referred to as imHere4U), a digital suicide prevention intervention for cyberbullied adolescents. The specific aims are to: Aim #1: Conduct a randomized controlled trial (RCT) comparing Flourish+Questionnaires vs. Questionnaires Alone among cyberbullied youth at-risk for suicide ages 12-17 (N=80, \>35% underserved youth). H2a. Primary outcome: Feasibility will be evidenced by recruitment/retention rates \> 80% and imHere4U engagement \> 70%. H2b. Secondary outcomes: Youth assigned to Flourish+Questionnaires will report improved problem-solving capacity, distress tolerance, and motivation and reduced distress and suicidal ideation than youth assigned to Questionnaires Alone over the 6-month follow-up period. Exploratory Aim: Examine the feasibility of delivering feedback on online interactions from machine learning algorithms. All youth assigned to Flourish may optionally provide their social media data to receive feedback from machine learning algorithms. H3a. Feedback from algorithms will have high acceptability (identified via qualitative themes and \>70% acceptance rates) and usability, defined by mean scores on Post-Study System and Usability Questionnaire (PSSUQ) \> 6.

Crisis Response Planning for Military Personnel

The study is a randomized trial comparing outcomes of active duty service members who present to the emergency department at risk for suicide and receive care from providers trained in crisis response planning versus those providing treatment as usual.

Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD

The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD.

Recovery Through Inspiration, Support, and Empowerment

The goal of this pilot study is to test the effectiveness of a novel intervention for young adults (ages 18-27) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and improve mental health recovery by using outpatient services. The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medications, anticipated outpatient appointments, and information on when and where to find community resources. The intervention being tested involves the implementation of a mental health recovery education and support program, involving one-on-one and small group meetings led by Peer Support Specialists (PSS) and Recovery Community Organizations (RCO). Participants will be assigned to either Cohort A or B for 8 weeks. Cohort A will be the intervention group with PSS and RCOs. * Weeks 1-4: One-on-one meetings with PSS for education and support. Assessments will be completed at weeks 2 and 4. * Weeks 5 and 7: One-on-one meetings with PSS for education and support. * Week 6 and 8: Group meetings with PSS and other participants from RCOs. Assessments will be completed during these weeks. Cohort B will be the SOC group with no PSS or RCOs. * Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at weeks 2 and 4. * Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and 8. Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.

Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Randomized 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 primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.

Inhibitory Mechanisms of Negative Urgency in Adolescent Suicidal Behavior

The goal of this study is to understand why some people act more impulsively when feeling negative emotions, which is called negative urgency. The researchers hope to understand how negative urgency relates to the way networks of brain cells communicate with one another. The researchers will measure negative urgency and brain signals in adolescents aged 13-21 years with depression and suicidal thoughts and behaviors. The main questions it aims to answer are: * Whether a type of brain signaling called cortical inhibition is related to negative urgency * Whether depressed adolescents with suicidal behavior have more problems with cortical inhibition than depressed adolescents with suicidal thoughts only * Whether the relationship between negative urgency and cortical inhibition changes over time Adolescents who participate in the study will complete the following activities at the time they join the study, as well as 6 months and 12 months later: * Interviews with researchers and questionnaires to learn about their thoughts, emotions, and symptoms * A questionnaire about impulsive behaviors and negative urgency * Computerized games that measure brain functions * An MRI scan of the brain * Transcranial magnetic stimulation with electroencephalography (TMS-EEG), a way to measure how brain cells communicate (cortical inhibition) using a magnet placed outside of the head and recording brain signals

Social Prescribing and Relationship Cognitive Strategies (SPARCS)

The study team is testing the acceptability and feasibility of two treatments for improving loneliness: Social Prescribing and Brief Cognitive Therapy. For this pilot study, the study team have adapted these treatments for Collaborative Care and are studying whether these are practical and well-received by patients that might use them.

User Evaluation Think Life

This study aims to evaluate user experiences with the online self-help course Think Life, a suicide prevention intervention for individuals experiencing suicidal thoughts. Think Life was developed by the Flemish Centre of Expertise in Suicide Prevention (VLESP) and is freely available via Zelfmoord1813.be. The course was originally developed in 2014 and updated in 2025 to improve its look and feel, usability, and inclusiveness, without fundamental changes to its core content. The researchers seek to better understand how users experience the updated version of Think Life, including perceived strengths, usability, and overall satisfaction with the course. Users of the Think Life self-help course will be invited through a call displayed on the course homepage to voluntarily participate in an online user evaluation study. Interested individuals can access an online informed consent form via a public internet link hosted on REDCap. Participants who provide online informed consent and meet the inclusion criteria will automatically be redirected to the online questionnaire, which is also hosted on REDCap. Approximately 1000 participants aged 18 years or older can be included in this study. Participants are invited to complete a one-time online questionnaire with an estimated completion time of approximately 10 minutes.

RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS

In this research study, investigators examine how brain activity changes during tests of emotional processing, attention, and memory using multimodal neuroimaging methods including electroencephalography (EEG), functional magnetic resonance imaging (fMRI), and functional near-infrared spectroscopy (fNIRS). Transcranial magnetic stimulation (TMS) is used to probe and modulate brain networks related to cognitive flexibility and emotion regulation. The study includes multiple related sub-studies involving healthy participants and participants with depression. Some study components focus on mechanistic modeling using non-therapeutic neurostimulation in healthy participants, while other components include interventional approaches such as individualized EEG-synchronized repetitive TMS (rTMS), cognitive tasks, and brief cognitive behavioral therapy (CBT) in participants with depression. Certain study components also evaluate CBT alone without TMS to assess behavioral intervention effects.

Student Precarity and Psychiatry

Since the COVID-19 pandemic, mental health disorders have increased significantly, particularly among young people. In France, the proportion of young people aged 18 to 25 suffering from depression almost doubled between 2017 and 2021. This phenomenon particularly affects students, who are already identified as being at greater risk of mental health disorders than the general population. Medical students seem to be particularly vulnerable: in 2021, a national study showed very high rates of depression and suicidal thoughts in this population. The main factor associated with depression was the feeling of financial hardship. Students often face multiple forms of insecurity. Financially, they have limited resources and struggle to cover their basic needs such as housing, food and healthcare. Socially, many experience significant isolation, particularly when they are away from their families or under pressure from their studies. All of this has a significant impact on their mental health. Unfortunately, many students do not seek help due to lack of time, resources, or awareness of support services. The 2021 study showed that only one-third of medical students suffering from depression received appropriate treatment. The aim of our study is to assess the impact of precariousness on the onset of psychiatric disorders and on the use or non-use of healthcare services. Our study will involve nearly 45,000 students from PSL and UPC universities. It is based on a longitudinal cohort (via questionnaires) over three years. The aim is to identify precisely the different aspects of student precariousness (housing, transport, isolation, economic difficulties, etc.) and their link with psychological distress. The study will measure the extent of the phenomenon and identify modifiable factors that could be targeted by preventive measures. The results will enable us to better target preventive measures and propose concrete solutions to improve students' well-being and promote their success.

Brief Crisis Therapy for Suicidal Children and Adolescents

The goal of this clinical trial is to learn if the Ultra-Brief Interpersonal Psychotherapy for Adolescents with Suicidal Ideation (IPT-A-SCI) works to reduce suicidal thoughts and behaviors in children and adolescents. The study will also examine whether treatment effects continue after treatment ends and whether some participants benefit more from the intervention than others. The main questions it aims to answer are: Does IPT-A-SCI reduce suicidal thoughts and behaviors in children and adolescents? Do the effects of IPT-A-SCI continue three months after treatment ends? Do some children and adolescents benefit more from IPT-A-SCI than others? Participants will: Receive IPT-A-SCI treatment consisting of five weekly sessions Complete questionnaires before treatment, during treatment, at the end of treatment, and three months after treatment ends Have their parents complete questionnaires at the same time points

Exploratory Analysis of Interpersonal and Intrapersonal Psychological Processes Implied in Risk-taking and Suicidal Behaviors, in Adult and Adolescent At-risk

In a recent report, Santé Publique France (2023), reported that 4.2% of 18-85 year-olds had thought about suicide in the last 12 months, and 6.8% had attempted suicide in their lifetime and 0.5% in the last year. Even more recently, the DREES (Direction de la recherche, des études, de l'évaluation et des statistiques auprès des Ministères Sociaux) published a report on May 16, 2024, showing a sharp rise in hospitalization rates for self-inflicted acts among female patients aged between 10 and 24, with a peak around age 15. Two-thirds of these hospitalizations for self-inflicted injuries are related to deliberate drug intoxication. Depression, bipolar disorders and schizophrenia spectrum disorders (among other psychological disorders) are known risk factors for suicide, which is the leading cause of death in this clinical context. In addition to these formalized psychopathological elements, risk behaviors underpinned by psychological processes common to suicide attempts are suspected and need to be studied in depth. Research into psychiatry and the psychopathology of suicide has identified a number of risk and protective factors. These psychological determinants - or processes - act alongside other key factors such as the environment and social ties. Life contexts can have an impact on health, and more specifically on the psychopathology of individuals, through disturbances of a biological, psychological and social nature. It is important to be able to describe what processes are at work and how they explain the development and maintenance of behaviours that put one's life and health at risk. This is part of a preventive approach to mental health. We suggest that the study of psychological processes such as suicidal ruminations, impulsivity and interpersonal needs (e.g. the interpersonal theory of suicide) is necessary to understand their involvement in risk-taking and suicidal behavior. To our knowledge, few studies of this type are underway in France, particularly with vulnerable clinical populations (adolescents/adults). The inclusion of a process-centered approach (Kinderman, 2015), in a transdiagnostic and preventive way, constitutes an innovative approach.

WeCare: A System of Care for Black Youth

The overall goal of this study is to respond to the urgent need for an effective suicide prevention strategy for Black youth by examining the effectiveness of a systems-level strategy to recognize and respond to suicide risk among Black adolescents who present to emergency departments (EDs). The proposed strategy, WeCare, combines combines three components: (1) universal screening using the Computerized Adaptive Screen for Suicidal Youth (CASSY), (2) a brief intervention designed for Black youth with elevated suicide risk in for ED settings, Connections for Safety (CFS), that combines safety planning and strategies to support linkage to outpatient mental health services, and (3) supportive text messages to youth and parent/caregivers for six weeks following the youth's ED visit. Study objectives are (1) to integrate input from multiple stakeholders to inform and facilitate WeCare implementation, and (2) to use a hybrid one effectiveness-implementation design to evaluate its effectiveness.

Transition Health and Resilience Through Valued Experiences (THRiVE) Pilot for Newly Separated Veterans

The objective of this study is to develop and pilot a program designed to improve mental health outcomes and reduce suicide risk during the transition from military to civilian life. It is hypothesized that the Transition Health and Resilience through Valued Experiences (THRiVE) program, to be developed as part of this study, will meet participant recruitment, retention, and satisfaction benchmarks (primary outcomes) and show positive preliminary effects on mental health symptoms, risk factors for suicidal ideation, and psychosocial functioning outcomes (secondary outcomes). The specific aims of this study are to: 1. Develop a small-group, peer-led, cross-cutting prevention program for newly separated veterans (NSVs) called THRiVE and 2. Evaluate the feasibility, acceptability, and preliminary effects of the THRiVE program on mental health symptoms, risk factors for suicidal ideation, and psychosocial functioning outcomes. Up to 40 NSVs participating in this Stage 1 pilot study will complete validated self-report measures at baseline, immediately after completing the THRiVE program (post-THRiVE), and 3 months after completing the THRiVE program (follow-up). The duration of a participant's time in the study is anticipated to be 5 months.

Climate Anxiety in a Young Population at Risk of Suicide

Climate change has become a major source of concern, particularly among younger generations who are facing the progressive degradation of ecosystems, loss of biodiversity, and alarming environmental information disseminated through the media. The direct perception of climate-related disruptions has been shown to engender a profound sense of helplessness and loss. This distress, termed eco-anxiety, is characterised by feelings of fear, sadness and guilt regarding the planet's future. In a context where there has been a marked increase in suicidal thoughts and attempts among young people over the past decade, it is essential to explore the psychological manifestations of eco-anxiety within this vulnerable population. The paucity of studies investigating this association underscores the significance of the present research. The aims of this study is to examine the relationship between climate anxiety and suicidal risk among young people aged 16 to 24 years. The study will encompass 108 young participants aged between 16 and 24 years, who are either hospitalised or receiving outpatient psychiatric care. Each participant will be required to complete one clinician-administered assessment, namely the Columbia Suicide Severity Rating Scale (C-SSRS), and two self-report questionnaires: the Climate Change Anxiety Scale - French version (CCAS-FR) and the State-Trait Anxiety Inventory (STAI-Y). Furthermore, a sociodemographic questionnaire will be administered in order to collect information regarding the subjects' age, sex, education level, living conditions, and psychiatric history. It is hypothesised that there is a positive association between climate anxiety and suicidal risk, with the most eco-anxious participants showing higher C-SSRS scores. It is further predicted that eco-anxiety will correlate with elevated levels of state and trait anxiety, with the potential for modulating this relationship by sociodemographic factors, including gender. This study will contribute to a better understanding of the psychological impacts of climate change on young people and help identify the most vulnerable profiles.

Social Media Intervention for Online Victimized Youth

This feasibility pilot trial seeks to examine the feasibility and target engagement of a coping skills and psychoeducational intervention delivered via an automated conversational chatbot named SMILEY in reducing frequency and stress associated with online victimization among marginalized youth, including those who are Black, Hispanic, and LGBTQ+, and experiencing depression and online victimization. The primary inquiry of this study is whether SMILEY can enhance the safety and decrease stress levels in online environments for marginalized youth coping with depression and online victimization. Participants will engage with materials, including interactive web resources, to learn safe social media practices and provide coping skills for experiencing online victimization. These materials will cover topics such as managing online time, addressing negative comments, and fostering positive connections. Participants will interact with SMILEY at their own pace over 4 weeks. This interaction will provide information and guidance on dealing with online victimization and the associated stress.