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| ID | Type | Description | Link |
|---|---|---|---|
| HT94252410947 | Other Grant/Funding Number | Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense | |
| CDMRP-TP230060 | Other Identifier | Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense | |
| 24-08-666-907 | Other Identifier | Biomedical Research Alliance of New York |
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| Name | Class |
|---|---|
| U.S. Army Medical Research Acquisition Activity | FED |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THRiVE | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transition Health and Resilience through Valued Experiences (THRiVE) Program | Behavioral | Six (6) total weekly, 90-minute, small-group, peer-led sessions delivered virtually |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 14 months |
| Participant retention rate | The percentage of participants who attend at least 4 of the 6 planned total THRiVE sessions | Through completion of the THRiVE group, an average of 2 months |
| 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. | At completion of the THRiVE group, an average of 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 5 months |
| PTSD Checklist for DSM-5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shannon M Blakey, PhD | Contact | 919-485-5427 | sblakey@rti.org | |
| Russ Peeler, MS | Contact | rvp@rti.org |
| Name | Affiliation | Role |
|---|---|---|
| Shannon M Blakey, PhD | RTI International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RTI International | Recruiting | Durham | North Carolina | 27713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41052716 | Derived | 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. |
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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. |
| Through study completion, an average of 5 months |
| 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. | Through study completion, an average of 5 months |
| 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. | Through study completion, an average of 5 months |
| Patient Health Questionnaire-9 | 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. | Through study completion, an average of 5 months |
| Interpersonal Needs Questionnaire | 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. | Through study completion, an average of 5 months |
| Positive and Negative Suicide Ideation Inventory | 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. | Through study completion, an average of 5 months |
| Military to Civilian Questionnaire | 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. | Through study completion, an average of 5 months |
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D019456 | Health Transition |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D011157 | Population Dynamics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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