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

Официальное название

Adapting Behavioral Activation to Improve Mental Health Outcomes and Reduce Suicide Risk During the Military Transition

Обзор

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.

Подробное описание

Transition from military to civilian life presents both opportunities and challenges. Although existing programs provide newly separated veterans (NSVs) with valuable support for their vocational well-being during the military transition, these programs do not fully address the psychosocial aspects of reintegrating into civilian life. This is problematic because the military transition is a time during which NSVs are at higher risk for developing mental health disorders and suicidal ideation. Although evidence-based treatments for common mental health concerns exist, cross-cutting prevention programs for NSVs are lacking. Behavioral Activation (BA), an evidence-based treatment that holds potential for optimizing psychosocial well-being during the military transition, could be adapted into a skills-based mental health promotion and suicide prevention program to fill this gap. This Phase 1 study involves a one-arm clinical trial to pilot test the program, called Transition Health and Resilience through Valued Experiences (THRiVE), in a sample of up to 40 NSVs. Primary outcomes include measures of feasibility (based on administrative data) and acceptability (based on administrative data and a validated self-report instrument). Mental health symptoms, risk factors for suicidal ideation, and psychosocial functioning will be assessed (using validated self-report instruments) at baseline, immediately post-THRiVE, and at follow-up 3 months after completing the THRiVE program. The duration of a participant's time in the study is anticipated to be 5 months. Findings from this pilot study will inform the design an anticipated larger, fully powered Stage 2 trial.

Вмешательства

• Поведенческое Transition Health and Resilience through Valued Experiences (THRiVE) Program
  Six (6) total weekly, 90-minute, small-group, peer-led sessions delivered virtually

Первичные конечные точки

• Participant recruitment rate [Срок оценки: 14 months]
• Participant retention rate [Срок оценки: Through completion of the THRiVE group, an average of 2 months]
• Client Satisfaction Questionnaire-8 [Срок оценки: At completion of the THRiVE group, an average of 2 months]

Вторичные конечные точки (8)

• Generalized Anxiety Disorder-7 [Срок оценки: Through study completion, an average of 5 months]
• PTSD Checklist for DSM-5 [Срок оценки: Through study completion, an average of 5 months]
• Alcohol Use Disorders Identification Test [Срок оценки: Through study completion, an average of 5 months]
• Drug Abuse Screening Test [Срок оценки: Through study completion, an average of 5 months]
• Patient Health Questionnaire-9 [Срок оценки: Through study completion, an average of 5 months]
• Interpersonal Needs Questionnaire [Срок оценки: Through study completion, an average of 5 months]
• Positive and Negative Suicide Ideation Inventory [Срок оценки: Through study completion, an average of 5 months]
• Military to Civilian Questionnaire [Срок оценки: Through study completion, an average of 5 months]

Критерии участия

Критерии включения

• Be either (a) a United States military veteran who separated no more than 12 months prior to study enrollment or (b) a United States transitioning service member on terminal leave
• Be at least 18 years old
• Have access to the internet; a desktop computer, laptop, tablet, or other "smart" device with video camera, speakers, and microphone; and a private place from which to attend THRiVE sessions
• Reside and complete all study activities within the United States

Критерии исключения

• Endorse lifetime manic, hypomanic, or psychotic episodes
• Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current severe alcohol use disorder or substance use disorder (except for tobacco use disorder, which will not be exclusionary)
• Screen positive for moderate or high acute risk for suicide
• Screen positive for more than minimal risk for other-directed violence
• Are receiving or plan to receive BA therapy for any mental health condition between enrollment and the 3-month follow-up assessment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• RTI International — Durham

Публикации

• Blakey SM, Vandermaas-Peeler JR, Counts J, Croxford J, Rae Olmsted KL, Gant P, Elbogen EB, Asman K. Bringing veteran mental health promotion and suicide prevention efforts upstream: The THRiVE study protocol. Contemp Clin Trials. 2025 Nov;158:108100. doi: 10.1016/j.cct.2025.108100. Epub 2025 Oct 4. PMID 41052716

Идентификаторы

NCT: NCT06778278 · 0219706 · HT94252410947 · CDMRP-TP230060 · 24-08-666-907

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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