Clinical trial NCT06778278: Transition Health and Resilience Through Valued Experiences (THRiVE) Pilot for Newly Separated Veterans
Official title: Adapting Behavioral Activation to Improve Mental Health Outcomes and Reduce Suicide Risk During the Military Transition
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Military Transition
Community Reintegration
Mental Health
Suicidal Ideation
Alcohol Misuse
Keywords: Military transition
Community reintegration
Mental health
Suicidal ideation
Transitioning Service Members
Newly separated Veterans
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research Acquisition Activity
First posted: 2025-01-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Be a United States military veteran
* Have separated/retired from the military no more than 12 months prior to study enrollment
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Participant recruitment rate
timeFrame: 14 months
measure: Participant retention rate
timeFrame: Through completion of the THRiVE group, an average of 2 months
measure: Client Satisfaction Questionnaire-8
timeFrame: At completion of the THRiVE group, an average of 2 months
Secondary outcomes:
measure: Generalized Anxiety Disorder-7
timeFrame: Through study completion, an average of 5 months
measure: PTSD Checklist for DSM-5
timeFrame: Through study completion, an average of 5 months
measure: Alcohol Use Disorders Identification Test
timeFrame: Through study completion, an average of 5 months
measure: Drug Abuse Screening Test
timeFrame: Through study completion, an average of 5 months
measure: Patient Health Questionnaire-9
timeFrame: Through study completion, an average of 5 months
measure: Interpersonal Needs Questionnaire
timeFrame: Through study completion, an average of 5 months
measure: Positive and Negative Suicide Ideation Inventory
timeFrame: Through study completion, an average of 5 months
measure: Military to Civilian Questionnaire
timeFrame: Through study completion, an average of 5 months
Other outcomes:
Locations:
Study officials:
affiliation: RTI International
name: Shannon M Blakey, PhD
role: PRINCIPAL_INVESTIGATOR
References: