Clinical Research Directory

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.

Safety Planning Intervention in Swedish Healthcare: A Multisite Study for Suicide Prevention

Suicide is one of the leading causes of premature death and a prioritized public health concern. Safety Planning Intervention (SPI) is a method with strong international research support for reducing suicidal behaviour by enhancing individuals' strategies for crisis management and improving access to support. SPI is a single-session intervention lasting approximately 45 minutes, which any healthcare provider can deliver after a brief training. Despite promising results, the implementation of SPI in Swedish healthcare remains limited. This project examines how SPI can be integrated into various healthcare settings and evaluates its impact on suicide-related emergency visits, psychiatric hospitalizations, and healthcare utilization. Data and Methods Stepped-Wedge implementation study in specialist psychiatry, where SPI is gradually introduced in psychiatric units. This study design allows for a robust evaluation of effects while ensuring all units eventually receive the intervention. As part of this study, a survey among healthcare professionals will be conducted to assess their experiences with feasibility, usability, and implementation barriers. Data will be collected from QlikView healthcare utilization data. Poisson regression models with mixed effects will be used to analyze the impact of SPI on emergency visits and psychiatric hospitalizations. A health economic analysis will be conducted to evaluate the cost-effectiveness of SPI. Societal Relevance and Impact The project contributes to Sweden's national suicide prevention strategy by: 1. Scientifically evaluating the feasibility and effects of SPI in Swedish healthcare. 2. Developing training programs for healthcare professionals in suicide prevention. 3. Informing policy decisions and national guidelines. 4. Analyzing the cost-effectiveness of SPI from a societal perspective. Implementation The research team includes experts in suicide prevention, psychiatry, epidemiology, patient safety, and health economics, creating a strong multidisciplinary foundation. The Stepped-Wedge design ensures an ethically and methodologically sound evaluation of SPI. Gradual implementation allows for time-based comparisons, minimizes selection bias, and ensures all patients receive the intervention. The project is conducted in close collaboration with healthcare providers and policymakers to ensure that research findings can be integrated into clinical practice and strengthen suicide prevention efforts in Sweden.

Suicide Preventive Psychosocial Treatment for Youths

Suicide is the leading cause of death amongst 10-18-year-olds in Sweden. Suicide attempts are the strongest predictor of subsequent death by suicide, often lead to inpatient care, and are associated with substantial societal costs, making suicide attempts a critical target in psychiatric intervention research. Although youths attempting suicide are typically assessed and treated for potential comorbid psychiatric conditions, there is currently no trans-diagnostic evidence-based treatment specifically targeting suicidal behavior. To fill this gap, the Safe Alternatives for Teens and Youths (SAFETY) was developed. SAFETY is a transdiagnostic family-based cognitive-behavioral suicide prevention program that has shown promise but more studies are needed. The overall objective of this project is to evaluate the efficacy, durability, and cost-effectiveness of the SAFETY intervention, a scalable suicide prevention intervention that can be offered immediately following a youth suicide attempt, in a fully powered single-blind randomized controlled superiority trial. Our primary hypothesis is that the SAFETY intervention will be superior to Enhanced Treatment As Usual (enhanced with the evidence-based intervention safety planning) in reducing the proportion of suicide reattempts. Moreover, we predict that these improvements will be maintained for up to 60 months post-treatment. Finally, we expect that SAFETY will be cost-effective compared to the control intervention, both at the primary endpoint and in the longer term.

Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk Among Patients With PTSD

The purpose of this research is to see if Crisis Response Planning (CRP), a brief strategy designed to help people cope effectively with emotional crises, combined with Cognitive Processing Therapy (CPT), a talk treatment for posttraumatic stress disorder (PTSD), will reduce suicidal thoughts and behaviors.

Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part A

This Study will comprehensively evaluate a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide. A Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used

Preventing Suicide With Digital Phenotyping and Pharmacogenetics-Based Interventions

The goal of this protocol for an observational retrospective multi-site cohort study is to develop a predictive algorithm for suicidal behavior integrating genetic risk markers, digital phenotypes, and exposomic data in people with a lifetime history of suicide attempt. Participants will be aged from 12 onwards (requiring parental consent if under 18) and only be excluded if they are unable to provide a genetic sample or do not consent to the study. The main question\[s\] it aims to answer is: \- Can genotyping/omics analysis of individuals with a history of suicidal behaviuor reveal potential genetic factors associated with suicide risk? Secondary questions include: 1. Can behavioral factors associated with suicide risk be explored through data obtained from Google Takeout? 2. Is there an association between medication changes and suicidal behavior, as identified through the Unified Prescription Module and the Digital Health Record? 3. Do different suicidal phenotypes differ based on the collected variables? 4. Can the investigators construct an exposome using geolocated and time-stamped data from Google Takeout, combined anonymously with data from the National Statistics and Meteorology Institutes? The investigators hypothesize that: 1. Individuals with a history of suicidal behavior will show significant genotypic differences compared to the general population (based on Spanish Genome Project data). 2. Suicidal phenotypes-especially between single and multiple attempters-will differ across collected variables, including genotype, omics, and exposome data. participants will complete genetic assessments, digital phenotypes, clinical questionnaires and exposomic data

Video Conference-Based Brief Cognitive Behavioral Therapy for Suicidal High-Risk Outpatients With Mood Disorders

This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effectiveness of videoconference-based brief cognitive behavioral therapy (V-BCBT) for adult outpatients with mood disorders who are at high risk for suicide. Eligible participants will be randomized (1:1) to either V-BCBT + treatment as usual (TAU) or TAU alone. V-BCBT consists of eight structured videoconference sessions (approximately 50-60 minutes each, twice weekly for 4 weeks) focusing on crisis management (for example, understanding the "suicide mode," developing a crisis response plan, strengthening reasons for living), cognitive and behavioral coping skills (for example, relaxation, behavioral activation, cognitive restructuring, mindfulness), and relapse prevention (for example, coping rehearsal and a relapse prevention plan).

Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting (Project HOPE)

This study will test whether a novel intervention, Virtual Hope Box Enhanced Facilitation (VHB-EF), reduces suicide risk in Veterans after discharge from inpatient psychiatric hospitalization. Additionally, this study will also conduct interviews with Veterans and healthcare providers to explore barriers and facilitators to future adoption of the VHB-EF intervention in healthcare settings.

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.

Teen Recovery Through Inspiration, Support, and Empowerment

The goal of this pilot study is to test the effectiveness of a novel intervention for teenagers (ages 15-18) 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 to improve mental health recovery by using an online recovery education and support program. The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources. The intervention being tested involves the implementation of an online recovery education and support (RES) program, involving one-on-one and small group meetings led by trained teen peers (TPs) and peer support specialists (PSS). Participants will be assigned to either Cohort A or B for 8 weeks. Cohort A will be the intervention group with online access to an RES, TP, and PSS. * Week 1-4: One-on-one meetings with PSS and TP for education and support. Assessments will be completed at week 2 and 4. * Week 5 and 7: one-one meetings with PSS and TP for education and support. * Week 6 and 8: small group meetings with PSS, TP, and other participants. Assessments will be completed during Weeks 6 and 8. Cohort B will be the SOC group with no PSS, TP, or RES. * 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 and8. 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.

Plan and Protect: Safety Planning for Teens in Rural Emergency Departments

The goal of this observational study is to determine whether implementing a culturally sensitive, tablet-based safety planning program called Plan \& Protect (P\&P) within rural emergency departments can improve home safety and reduce suicide risk in adolescents presenting with suicidality. The main questions it aims to answer are: * Will implementing P\&P increase caregiver-reported home safety (reduce access to firearms and unsafe medication storage) for adolescents 12-17 years old presenting to rural EDs with suicidal ideation, self-harm, or mental health crisis? * Will implementing P\&P decrease adolescent-reported perceived suicide risk and related outcomes (e.g., suicide events, and attendance at follow-up mental healthcare)? Researchers will compare outcomes for adolescents and caregivers receiving P\&P (implemented as the new standard of care at sites during the intervention periods) to those receiving usual care (prior to P\&P implementation at those hospitals) to see if P\&P increases home safety and decreases suicide risk and related healthcare utilization. Participants will, if clinically appropriate: * Complete the tablet-based P\&P modules during their ED visit * Complete self-report measures at baseline, \~30 days, and \~3 months post-discharge * A subset will also participate in semi-structured interviews

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.

A One-Arm Open Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior

This study aims to evaluate the acceptability, safety, and preliminary 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.

Improving Care, Accelerating Recovery and Education

The goal of this clinical trial is to test the I-CARE program in children who are in a medical hospital awaiting inpatient mental health treatment. The main questions it aims to answer are: * Can the I-CARE program be used at the medical hospitals and do the patients and hospital staff like the program? * Does the I-CARE program lower patients' emotional distress, thoughts about suicide or suicide attempts? Patients will complete as many of the 7 I-CARE videos as possible during their stay at the medical hospital and fill out online surveys. There are workbook activities that go with each I-CARE video. A hospital staff member will help the patient do the videos and workbook activities.

Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part B

This Study will evaluate the implementation of a multi-component suicide prevention technology (Jaspr Health) that facilitates delivery of suicided-related evidence-based practices (EBPs) while replacing wasted waiting time with productive time in the Emergency Departments (EDs). The EBPs satisfy several key performance elements for systems adopting Zero Suicide. A Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Study Design (CREID) will be used

Suicidal Ideation Framework: Grounded Theory Study, Catalonia

This doctoral project aims to develop a comprehensive theoretical model of the process through which the suicidal ideation framework is configured as a symbolic, narrative, and relational expression, adopting a multiperspective approach that spans the suicide attempt and the stages of care and recovery. Moving away from biomedical reductionisms, this investigation seeks to identify shared meaning-making nuclei and discursive fractures that reflect the inherent conflictuality of the suicidal act. Grounded in the integration of the theoretical frameworks previously outlined, this study adopts an interpretive-constructivist approach. Phase 1 will include studies conducted in OECD countries, providing a broad and conceptually diverse interpretive foundation. Phase 2, conducted in Catalonia, will deepen situated configurations, assuming that local sociocultural frameworks act as interpretive prisms for globally relevant phenomena. Overall, this theoretical-methodological architecture not only ensures conceptual robustness and coherence, but also articulates an ethical and epistemic commitment to understanding suicide through the complexity of its human textures. By centering suffering, listening to historically silenced voices, honoring the singularity of each life trajectory, and grounding the inquiry in an ethics of care, this study aims to transcend a merely technical-instrumental logic of knowledge.

Lock and Protect: Reducing Adolescent Access to Lethal Means of Suicide

The primary goal is to determine the acceptability and feasibility of implementing the Lock and Protect decision aid. The secondary goals are to identify the potential short-term impact of Lock and Protect on home firearm and medication storage, parental self-efficacy. Using interviews with caregivers, the study will clarify the acceptability, feasibility, and barriers to implementing the Lock and Protect hone safety plan. This will allow further development of effective strategies to subsequently further test and use Lock and Protect in the ED. NOTE: The study will only recruit guardians and their adolescents from the pediatric ED at Morgan Stanley Children's Hospital NY-Presbyterian.

Attempted Suicide Short Intervention Program for Older Adults (ASSIP-OA): An Evaluation of a Psychosocial Intervention for Suicidal Adults Aged 65+

Older adults are sorely underrepresented in suicide prevention research, despite the fact that suicide rates are higher in this age group than in any other age group in Sweden and in many countries worldwide. There are extremely few clinical intervention studies that target this age group, with to date no published studies in Europe. The overall aim is to develop and test a modified version of the Attempted Suicide Short Intervention Program (ASSIP), which the investigators will adapt specifically for older adults (65+). The original ASSIP was developed in Switzerland where it has shown an 80% decrease in risk of new suicide attempts compared to ordinary treatment. In Sweden, ASSIP is currently being tested for persons aged 18+ . The investigators now propose a randomised controlled trial (RCT) to evaluate a modification of ASSIP specifically designed to meet the needs of suicidal persons aged 65 and above, the ASSIP-Older Adult program (ASSIP-OA). Main study questions 1. Compared to treatment as usual (TAU), will the addition of the ASSIP-OA to ordinary treatment have a preventive effect on suicide and suicide attempts within 6, 12, and 24 months following the index episode? 2. Compared to TAU, do ASSIP-OA participants show better improvement in coping skills and psychiatric symptoms a) after the last session and b) at 6-,12- and 24- month follow-up? 3. Is a brief preventive intervention (ASSIP-OA) for older adults feasible, based on its acceptability, appropriateness, deliverability and fidelity? Do participants experience side effects? Do they have fewer days of inpatient care? 4. What kind of challenges and opportunities do a) older adults and b) ASSIP-OA therapists experience in relation to implementing a brief preventive intervention like ASSIP-OA? Are the modifications that the investigators made in ASSIP-OA relevant for older adults?

Efficacy of the I-CARE Digital Health Intervention

When presenting to an ED with suicide, self-harm or other mental health crises, youth may also experience "boarding", which is defined by the Joint Commission as "the practice of holding patients in the ED or another temporary location after the decision to admit or transfer has been made." A recent national survey of 88 US acute care hospitals conducted by our research team found that 98.9% of hospitals were boarding youth awaiting psychiatric hospitalization, for an average of 2-3 days. However, as illustrated in a systemic review, little research has focused on developing interventions to support youth during this highly vulnerable time. 3 I-CARE is a modular, blended digital health intervention facilitated by individuals who are not mental health clinical staff to teach youth evidence-based psychosocial skills during the boarding period. This study will evaluate I-CARE's efficacy using a patient-level randomized clinical trial (RCT), randomizing youth to receive standard safety supervision or I-CARE in addition to standard safety supervision. If found to the efficacious, I-CARE could be scaled-up in new settings with limited resources and has the potential to significantly improve the quality of care received by youth experiencing boarding.

Advancing Student Suicide Interventions With Scalable Technologies

Mobile-based applications, such as JasprHealth, can deliver evidence-based skills intended to reduce imminent suicide risk (e.g., reducing means access), improve emotional states (e.g., via distraction and coaching to act opposite to emotions), and reduce feelings of social isolation (e.g., via shared stories), but user engagement is a barrier. The aim of this study was to examine the effects of a technological application resource (Jaspr) relative to human augmentation (Jaspr+, e.g., motivationally focused orientation plus prompts) on acceptability, preliminary effectiveness, and engagement among college students who screen positive for suicide risk.

Enhanced Brief CBT for Suicidal Inpatients With Mood Disorders

The goal of this clinical trial is to evaluate whether enhanced brief cognitive behavioral therapy (E-BCBT) can help reduce suicidal thoughts and behaviors among psychiatric inpatients. This therapy is designed to be feasible during hospitalization and includes self-directed worksheets that may later be used independently after discharge, offering potential benefits for suicide prevention outside the hospital setting as well. Participants will be randomly assigned to one of two groups: * E-BCBT group: Participants will receive five sessions of cognitive behavioral therapy (approximately 50-60 minutes each) during their inpatient stay. * TAU (treatment as usual) group: Participants will receive standard care provided on the psychiatric ward. All participants will take part in five assessments: one before treatment, one after treatment, and three monthly follow-up assessments over the three months after discharge. Assessments include interviews, conducted in person or by phone, and questionnaires, completed online via a survey link. The entire study period will take approximately four months.

Efficacy of a Smartphone Suicide Prevention App

It is an interventional research, single-blind, randomized, controlled, multicenter, which involves only minimal risks and constraints. Patients who attend to the emergency department following a SA (Suicidal Attempt) represent a key group of patients with an extremely high risk of suicide in the short term. A main problem in suicide prevention is that the increase of symptoms and suicidal risk occurs most often in the natural environment of patients, away from the system of care. Thus, the main goal in allowing real-time risk detection would facilitate immediate interventions, probably the best way to prevent a suicidal act. Additionally, the evolution of the suicidal crisis is very variable from one subject to another, in duration and symptoms, and often very brief. In contrast, the tools used to assess suicidal thoughts have so far been limited to intermittent assessments separated by weeks, months or years, which does not take into account the fact that suicidal thoughts can be highly variable over a few hours and that suicide attempts can occur in response to a rapid increase in thoughts over periods as short as the day. Mobile health (mHealth) interventions are the only that can respond to these fluctuations over time. We have developed the first French app (emma) for EMA (Ecological Momentary Assessment) , customised EMI (Ecological Momentary Intervention) and prediction of SB (suicidal behaviour). It was designed by integrating evidence-based suicide prevention strategies and recommendations for the development of apps in the field of mental health. Emma helps to strengthen the patient's connection to his healthcare system and social network. This study led to the development and subsequent deployment of VigilanS. VigilanS is a multi-regional innovative care program for the prevention of suicide relapse, which has been implemented in several emergencies departments in France. Our hypothesis is that emma offers an unprecedented opportunity to increase the efficiency of VigilanS, both for patients, by restoring their social connections, and for health professionals, in a simple, fast and efficient way. Thanks to emma, the patient will have daily support adapted to his condition (emotion management modules, safety plan, calls in case of emergency). Emma will fit easily into the daily practice of health professionals (little binding, little time consuming) and will complete the range of care organized by VigilanS. The main objective is to evaluate over a 6-months follow-up the efficacy of a smartphone app (emma) in addition to the VigilanS program on the prevention of a suicidal event (suicide, SA, hospitalization or emergency department for suicidal ideation) compared to the VigilanS program only.

Piloting a Culturally Adapted Suicide Prevention for Black Students in Chicago

Suicide has been the third leading cause of death for Black youth in the U.S since the 1980s and persists as a leading cause of death for Black youth today. For example, in 2018 suicide was reported as the 2nd leading cause of death among Black Americans ages 10 to14 years old. Findings yielded from recent queries indicate that the gap in suicides among Black males and female youth has narrowed in recent years. Despite these disturbing trends, a dearth persists in our understanding of the factors that contribute to and prevent against suicide in Black youth, thus diminishing researchers' ability to effectively detect suicide risk in this particular population. This project aims to redress this gap by proposing the cultural adaptation of an existing suicide prevention intervention, the Signs of Suicide (SOS) prevention program, for Black middle school students. Our team will conduct a pilot randomized controlled trial among a sample of Black middle school students to assess feasibility and examine underlying mechanisms that contribute to suicidality among Black youth. Intervention content will be adapted to assess how topics of racial identity, racial socialization, and racial discrimination uniquely impact Black youth's mental health experiences and risk for suicide. Measures of suicidal ideation, planning, and attempt will be assessed at pre-test, post-test, and 3-months after the intervention. Findings derived from this project will contribute to public health priorities by offering unique insight into the factors that either prevent or promote suicide among Black youth and could be replicated in other schools serving Black students across the nation.