Transition Health and Resilience Through Valued Experiences (THRiVE) Pilot for Newly Separated Veterans
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRTI International
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Transition Health and Resilience through Valued Experiences (THRiVE) Program
BehavioralSix (6) total weekly, 90-minute, small-group, peer-led sessions delivered virtually
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: THRiVEExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Participant recruitment rate
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).
Time frame
14 months2
Participant retention rate
The percentage of participants who attend at least 4 of the 6 planned total THRiVE sessions
Time frame
Through completion of the THRiVE group, an average of 2 months3
Client Satisfaction Questionnaire-8
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.
Time frame
At completion of the THRiVE group, an average of 2 monthsSecondary outcomes
1
Generalized Anxiety Disorder-7
Changes in past-2-week anxiety symptoms from baseline to follow-up. Possible scale scores range 0 to 21, with higher scores indicating greater anxiety symptom severity.
Time frame
Through study completion, an average of 5 months2
PTSD Checklist for DSM-5
Changes in past-month posttraumatic stress symptoms from baseline to follow-up. Possible scale scores range 0 to 80, with higher scores indicating greater posttraumatic stress symptom severity.
Time frame
Through study completion, an average of 5 months3
Alcohol Use Disorders Identification Test
Changes in hazardous or harmful alcohol use from baseline to follow-up. Possible scale scores range 0 to 40, with higher scores indicating more hazardous or harmful alcohol use.
Time frame
Through study completion, an average of 5 months4
Drug Abuse Screening Test
Changes in drug misuse consequences from baseline to follow-up. Possible scale scores range 0 to 10, with higher scores indicating greater drug misuse consequences.
Time frame
Through study completion, an average of 5 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
RTI International
Lead sponsor
U.S. Army Medical Research Acquisition Activity
Collaborator
Source ClinicalTrials.gov