Clinical Research Directory

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).

Expanding Veteran Sponsorship Initiative+ to Support High-Risk Transitioning Servicemembers and Veterans: A Precision Medicine Approach

Background Young Veterans in the U.S. face a heightened risk of suicide, particularly during the first year after leaving military service-a period often referred to as the "deadly gap." Suicide rates among Veterans aged 18 to 34 have nearly doubled since 2001, and research shows that reintegration challenges during this transition are closely linked to increased suicide risk. The Veteran Sponsorship Initiative (VSI) was developed to address this critical period by connecting Transitioning Servicemembers and Veterans (TSMVs) with trained, VA-certified peer sponsors. These sponsors help TSMVs navigate civilian life and access VA care. Early evaluations show that TSMVs matched with sponsors are more likely to report lower levels of reintegration difficulties, higher levels of social support, engage in VA services and report lower rates of depression and suicide risk. This project enhances VSI by integrating predictive analytics-developed in partnership with Harvard Medical School and the DoW STARRS-LS team-to identify high-risk TSMVs before they leave the military. Those identified receive not only a sponsor but also targeted VA mental and health care services. This hybrid effectiveness-implementation study will evaluate the impact of this enhanced model (VSI+) on mental health outcomes and VA engagement among 2,700 high-risk TSMVs. Method/Design The purpose of this PEI proposal is to evaluate VSI expansion into VSI+ with enrollment occurring on four US Army installations (FY2026-2027). The study employs a pragmatic cluster-randomized trial with embedded mixed-method implementation evaluation to compare three arms: 1. Transition as Usual (TAU) 2. VSI Base= peer sponsorship and community support 3. VSI+= VSI Base plus VA stepped care services The evaluation is guided by the RE-AIM framework to assess: * Reach (enrollment rates) * Effectiveness (reintegration difficulties, depression, anxiety, suicidal ideation/behavior, and VA utilization outcomes) * Adoption (site and staff uptake) * Implementation (fidelity and feasibility) * Maintenance (sustainability) Study Aims 1. Effectiveness: Evaluate the impact of VSI Base and VSI+ on reintegration difficulties, depression, anxiety, suicidal ideation/behavior, and VA utilization outcomes. 2. Implementation: Assess the feasibility and fidelity of implementing VSI Base and VSI+ across multiple sites using a bundled strategy. 3. Economic Impact: Estimate the budget impact of VSI Base and VSI+ on healthcare costs, including inpatient, emergency, and outpatient care.

National Sponsorship Program for Transitioning Service Members

Background: The United States is undergoing a suicide epidemic for its youngest Veterans (18-to-34-years-old) as their suicide rate has almost doubled since 2001. Veterans are at the highest risk during their first-year post-discharge, thus creating a "deadly gap" for them. In response, the nation has developed strategies that emphasize a preventive, universal and public health approach and embrace the value of community interventions. The three-step theory of suicide suggests that community interventions that reduce pain from reintegration difficulties and promote connectedness for Veterans as they transition to civilian life have the greatest likelihood of success. Recent research shows that the effectiveness of community interventions can be enhanced when augmented by volunteer and certified sponsors (1-on-1) who actively engage with Veterans, as part of the Veterans Affairs' Transitioning Servicemember/Veteran (TSMV) Sponsorship Initiative. Method/Design: The purpose of this trial is to determine how to implement the Veteran Sponsorship Initiative in six cities in Texas in collaboration with the US Department of Defense, VA, Texas government, and local stakeholders. Texas is an optimal location for this large-scale implementation as it has the second largest population of Veterans aged 18-to-34-years-old and is home to the largest US military installation, Fort Hood. The first aim is to further determine the effectiveness of the Sponsorship Initiative, as evidenced by measures of proximal variables (reintegration difficulties, health/psychological distress, VA healthcare utilization and connectedness) and distal variables (suicidal ideation and behaviors). The second aim is to determine how best to implement the Veteran Sponsorship Initiative in Texas with the intent of future expansion in more states. TSMVs (n=630) will be recruited from military installations six months prior to discharge and prior to moving to target cities. The evaluators are utilizing implementation strategies, such as building community partnerships and external facilitation. Evaluation will be conducted through interviews with TSMVs and periodic reflections with key stakeholders to identify barriers, facilitators, and adaptations. Outcome evaluations will be conducted with TSMVs completing surveys and data collection from working with stakeholders. Discussion: This evaluation will have important implications for the national implementation of community interventions that address the epidemic of TSMV suicide. Aligned with the Evidence Act, it is the first large-scale implementation of an evidence-based practice that conducts a thorough assessment of TSMVs during the "deadly gap".

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.

Transformative Mixed Evaluation of a Suicide Attempt Recovery Intervention

This study aims to evaluate the impact of a brief clinical group intervention based on the recovery model aimed at adult repeat suicide attempters attending an outpatient unit belonging to a public hospital in the Maule region, comparing two groups, one experimental and one wait group, considering indicators of clinical recovery (suicidal ideation, repetition of suicide attempt, functional disability, depressive symptoms), life satisfaction, social support, user satisfaction and personal recovery experiences lived by adult repeat suicide attempters.