Adapting Behavioral Activation to Improve Mental Health Outcomes and Reduce Suicide Risk During the Military Transition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Participant recruitment rate
研究概览
简要总结
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:
- Develop a small-group, peer-led, cross-cutting prevention program for newly separated veterans (NSVs) called THRiVE and
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
THRiVE
干预措施: Transition Health and Resilience through Valued Experiences (THRiVE) Program (Behavioral)
结局指标
主要结局
Participant recruitment rate
时间窗: 14 months
The percentage of NSVs who are determined to be eligible based on their eligibility assessment and choose to enroll. It is anticipated that recruitment will begin May 2025 and enrollment of the final participant will be July 2026 (a recruitment/enrollment window of 14 months).
Participant retention rate
时间窗: Through completion of the THRiVE group, an average of 2 months
The percentage of participants who attend at least 4 of the 6 planned total THRiVE sessions
Client Satisfaction Questionnaire-8
时间窗: At completion of the THRiVE group, an average of 2 months
Participant self-reported satisfaction with the THRiVE program at post-THRiVE. Possible scale scores range 8 to 32, with higher scores indicating greater program satisfaction.
次要结局
- Generalized Anxiety Disorder-7(Through study completion, an average of 5 months)
- PTSD Checklist for DSM-5(Through study completion, an average of 5 months)
- Alcohol Use Disorders Identification Test(Through study completion, an average of 5 months)
- Drug Abuse Screening Test(Through study completion, an average of 5 months)
- Patient Health Questionnaire-9(Through study completion, an average of 5 months)
- Interpersonal Needs Questionnaire(Through study completion, an average of 5 months)
- Positive and Negative Suicide Ideation Inventory(Through study completion, an average of 5 months)
- Military to Civilian Questionnaire(Through study completion, an average of 5 months)
研究者
Shannon Blakey
Research Clinical Psychologist
RTI International