A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans

Study Overview
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Brief Summary
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Risk of Veteran suicide is elevated during the first year of transition from military service to civilian life. Most Veteran suicides occur among Veterans who are not connected to VA healthcare. Suicide prevention and connection to care are therefore critical for recently transitioning Veterans. Transitioning Veterans require services to provide them with suicide prevention education, skills to manage their transition effectively, and support in their access to VA healthcare. Convenient, accessible, palatable, patient-centered care options that are cost-effective, easy to implement nationwide, and target domains known to mitigate suicide risk are needed during this critical transition period. This proposal would bridge this important healthcare gap using STEP-Home-SP, a transdiagnostic, non-stigmatizing, skills-based workshop. STEP-Home-SP will provide Veterans with suicide prevention education, skills to improve transition, support to access VA care, and a platform to decrease social isolation early in their military to civilian transition, thereby reducing suicide risk downstream.

Detailed Description
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Veterans face a deadly gap during their first year of transition from military to civilian life with limited available psychiatric services and increased suicide risk factors. During this critical transition period, Veteran suicide rate is double that of active service members and the general Veteran population. An average of 20 Veterans die from suicide each day, but only 6 of the 20 use VA services. VA care engagement has been shown to mitigate suicide risk; therefore, promoting engagement during the deadly gap could be essential to suicide prevention. Transitioning Veterans require outreach and services to provide them with support in their access to VA healthcare, suicide prevention education, and skills to manage their transition effectively. This proposal would bridge this important healthcare gap using STEP-Home. STEP-Home is an evidence-based, transdiagnostic, video telehealth rehabilitation workshop to improve reintegration, social support, and functioning among Veterans with high clinical comorbidity. STEP-Home is non-clinical, cost-effective, and skills-focused to maximally engage Veterans not participating in treatment who may be resistant to traditional mental health diagnostically focused approaches. To date, STEP-Home has not been adapted for the unique needs of recently transitioning Veterans or augmented for suicide prevention. This proposal will adapt and refine STEP-Home specifically for recently transitioning Veterans and add suicide prevention content and skills to create STEP-Home-SP. The proposed pilot study is designed to support STEP-Home and suicide prevention content experts in their refinement and evaluation of STEP-Home-SP. The investigators will utilize the VA/Department of Defense Identity Repository (VADIR) to recruit recently transitioned Veterans nationwide. In Aim 1, the investigators will develop STEP-Home-SP by adapting the STEP-Home telehealth intervention to specifically target recently transitioned Veterans and augment the workshop to include suicide prevention. In Aim 2, the investigators will conduct a two-arm proof-of-concept acceptability and feasibility randomized controlled trial (RCT) of STEP-Home-SP versus Enhanced Usual Care (EUC=current standard of care + educational packet on suicide risk and connection to VA care) in recently transitioned Veterans. Lastly, the investigators will explore reintegration status, VA care initiation, and candidate outcomes for STEP-Home-SP relative to EUC to inform a future full-scale RCT. If successful, fostering social, vocational, and community connection; building emotion regulation and impulse control skills; facilitating safety planning; and providing education and access to VA care upstream should result in decreased suicide risk during this critical transition and beyond.

Official Title
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A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans

Conditions
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TBI, Suicide Prevention, Veterans, PTSD, Transdiagnostic, Anger

Intervention / Treatment
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* Behavioral: STEP-Home-SP
* Behavioral: Transition Assistance Program
* Behavioral: VA Solid Start


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recently transitioned Veterans within one year of separation from military service Self-reported functional impairment or reintegration difficulties as measured by the Military-to-Civilian Questionnaire (any item score > 1 indicating some difficulty; M2CQ; [71]) Sufficient English fluency Agree to participate (informed consent/HIPAA) Exclusion Criteria: Active psychosis Imminent or acute high suicide risk requiring immediate crisis intervention (low-moderate non-imminent risk for suicide is allowed) Current moderate or severe substance use disorder Neurological diagnosis excluding TBI Participants with mild substance use disorder will be allowed Substance use is a common behavior that may contribute to reintegration difficulties and suicide risk

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Following T1 baseline assessment, participants will be randomized to STEP-Home-SP + Usual Care or Usual Care (UC) using randomly permuted block sizes stratified by presence or absence of SI.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEP-Home-SP + Usual Care<br>The core skills of emotional regulation and problem solving are introduced and integrated throughout all Veteran-specific reintegration content modules for practice and repetition for 12 weeks. Attention training augments emotional regulation and problem solving core skills and is interspersed throughout group and individual sessions. Additional 30-minute individual skill building and goal setting sessions occur  4-6 times based on individual Veteran needs | Behavioral: STEP-Home-SP<br>* This group will meet for  1.5 hours/week for 12 weeks. The core skills of Emotional Regulation (ER) and Problem Solving (PS) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention training augments ER and PS skills and is interspersed throughout the group and individual sessions. Additional 30-minute individual skills building and goal setting sessions occur up to 6 times based on individual Veteran needs. STEP-Home staff will work in pairs to run workshops per established protocols. Workshops will be conducted via VA approved video telehealth.<br>Behavioral: Transition Assistance Program<br>* Provides training, skills, and information to help transitioning service members and their families prepare for the military to civilian transition. Each service member works with a TAP counselor to identify needs and post transition goals to build an Individual Transition Plan, in addition to TAP core curriculum courses.<br>* Other names: TAP;Behavioral: VA Solid Start<br>* VA Solid Start includes a series of outreach calls and emails to all Veterans at 90-, 180-, and 365-days post service separation. Callers follow a standard script to describe services available through VA and provide contact information for desired services.<br>|
| Active Comparator: Usual Care<br>UC will include the Transition Assistance Program (TAP) as scheduled by DOD prior to military separation, VA Solid Start post-separation, and educational augmentation post-separation. | Behavioral: Transition Assistance Program<br>* Provides training, skills, and information to help transitioning service members and their families prepare for the military to civilian transition. Each service member works with a TAP counselor to identify needs and post transition goals to build an Individual Transition Plan, in addition to TAP core curriculum courses.<br>* Other names: TAP;Behavioral: VA Solid Start<br>* VA Solid Start includes a series of outreach calls and emails to all Veterans at 90-, 180-, and 365-days post service separation. Callers follow a standard script to describe services available through VA and provide contact information for desired services.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility- recruitment interest | ratio interested of those approached for the workshop | Through study completion, an average of one year. | 
| Feasibility- enrollment | Ratio enrolled (consented) of those approached, greater than 20% of those interested enroll in the proposed time frame | Through study completion, an average of one year. | 
| Feasibility- qualitative via Narrative Evaluation of Intervention Interview | Identification of challenges and facilitators during the recruitment process as assessed by study staff as well as feedback from focus group participants generated using the Narrative Evaluation of Intervention Interview (NEII). This is an interview composed of 16 open ended questions that allows participants to evaluate the process and outcomes of the intervention. Reviewers will generate a list of themes based on the responses to this interview. | Through study completion, an average of 3 months. | 
| Feasibility- Treatment Fidelity/adherence | Supervisor and therapist Likert rating of adherence to content for core skills and treatment modules, less than 20% deviations on a treatment fidelity scale. Lower scores indicate stronger treatment fidelity, with each question being answered on a scale from 1 (Strongly Agree) to 5 (Strongly Disagree). | Through study completion, an average of 1 week. | 
| Acceptability- Veteran adherence | Attendance rate for the 12-session workshop | Through study completion, an average of one year. | 
| Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change | Client satisfaction questionnaire (CSQ-8), total scores range from 8 to 32 with higher scores indicating higher satisfaction. A priori criteria is that greater than 80% of participants will score greater that a 24 on the CSQ-8. | Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks) | 
| Reintegration status- Military to Civilian Questionnaire (M2CQ) Change | 16 questions are answered on a scale from 0 (no difficulty) to 4 (extreme difficulty), with lower scores indicating more successful reintegration. | Assessed at screening, baseline (0 weeks), T4 (after 12 weeks) and T5 (after 24 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement in VA Care | Electronic medical record data (if available) showing occurrence of one or more healthcare appointments | Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Veterans, TBI, Transdiagnostic, Intervention, Suicide Prevention, PTSD, Reintegration