RTI International
Durham, North Carolina, 27713, United States
Location status: Recruiting
Location contact
Principal Investigator
CONTACT
Shannon M Blakey, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06778278
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27713, United States
Location status: Recruiting
Principal Investigator
CONTACT
Shannon M Blakey, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Six (6) total weekly, 90-minute, small-group, peer-led sessions delivered virtually
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: Through study completion, an average of 5 months
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 months
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 months
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 months
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 months
Changes in past-2-week depression symptoms from baseline to follow-up. Possible scale scores range 0 to 27, with higher scores indicating greater depression symptom severity.
Time frame: Through study completion, an average of 5 months
Changes in thwarted belongingness and perceived burdensomeness from baseline to follow-up. Possible thwarted belongingness subscale scores range 9 to 63, with higher scores indicating greater thwarted belongingness. Possible perceived burdensomeness subscale scores range 6 to 42, with higher scores indicating greater perceived burdensomeness.
Time frame: Through study completion, an average of 5 months
Changes in past-2-week protective and negative risk dimensions of suicidal ideation from baseline to follow-up. Possible protective dimension subscale scores range 6 to 30, with higher scores indicating greater protective factors. Possible negative risk dimension subscale scores range 8 to 40, with higher scores indicating greater negative risk factors.
Time frame: Through study completion, an average of 5 months
Changes in psychosocial functioning from baseline to follow-up. Possible scale scores range 0 to 4, with higher scores indicating greater difficulties with psychosocial functioning.
Contact information is provided by the study sponsor or research team.
Russ Peeler, MS
CONTACT
Shannon M Blakey, PhD
CONTACT
RTI International
Other
Adapting Behavioral Activation to Improve Mental Health Outcomes and Reduce Suicide Risk During the Military Transition
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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