Clinical trial NCT05995678: A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans
Official title: A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: TBI
Suicide Prevention
Veterans
PTSD
Transdiagnostic
Anger
Keywords: Veterans
TBI
Transdiagnostic
Intervention
Suicide Prevention
PTSD
Reintegration
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-08-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility- recruitment interest
timeFrame: Through study completion, an average of one year.
measure: Feasibility- enrollment
timeFrame: Through study completion, an average of one year.
measure: Feasibility- qualitative via Narrative Evaluation of Intervention Interview
timeFrame: Through study completion, an average of 3 months.
measure: Feasibility- Treatment Fidelity/adherence
timeFrame: Through study completion, an average of 1 week.
measure: Acceptability- Veteran adherence
timeFrame: Through study completion, an average of one year.
measure: Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change
timeFrame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Reintegration status- Military to Civilian Questionnaire (M2CQ) Change
timeFrame: Assessed at screening, baseline (0 weeks), T4 (after 12 weeks) and T5 (after 24 weeks)
Secondary outcomes:
measure: Engagement in VA Care
timeFrame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
Other outcomes:
measure: Difficulties in Emotional Regulation Scale (DERS)
timeFrame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Problem Solving Inventory (PSI)
timeFrame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Attention-Related Cognitive Errors Scale (ARCES)
timeFrame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Suicidal Ideation- The Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Assessed at screening, baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks). Will also be administered as needed following workshop sessions.
measure: Post-deployment Readjustment Inventory (PDRI)
timeFrame: Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: State-Trait Anger Expression Inventory (STAXI-2)
timeFrame: Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Functional status measured using the WHO Disability Assessment Schedule 2.0 12-item (WHODAS-2.0)
timeFrame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Stigma- Perceived Barriers to Care Survey
timeFrame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Quality of Life Scale (QOLS)
timeFrame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Psychosocial Functioning- The Brief Inventory of Psychosocial Functioning (IPF-Brief)
timeFrame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Social support subscale of the Deployment Risk and Resilience Inventory (DRRI-2)
timeFrame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Interpersonal Needs Questionnaire (INQ)
timeFrame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Depression- Patient Health Questionnaire (PHQ-9)
timeFrame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Hopelessness- Beck Hopelessness Scale
timeFrame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Self-injurious thoughts and behaviors interview (SITBI)
timeFrame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Suicide Coping/Safety Behaviors- Suicide Related Coping Scale (SRCS)
timeFrame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Gateway to vocational and community activities- Treatment & Activities Survey
timeFrame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
measure: Kessler-6 brief mental health screen
timeFrame: Baseline (0 weeks)
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Catherine B Fortier, PhD
role: PRINCIPAL_INVESTIGATOR
References: