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

NCT ID: NCT05995678

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2027-05-31

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.

Conditions

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TBI Suicide Prevention Veterans PTSD Transdiagnostic Anger

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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STEP-Home-SP + Usual Care

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

Group Type EXPERIMENTAL

STEP-Home-SP

Intervention Type BEHAVIORAL

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.

Transition Assistance Program

Intervention Type BEHAVIORAL

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.

VA Solid Start

Intervention Type BEHAVIORAL

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.

Usual Care

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.

Group Type ACTIVE_COMPARATOR

Transition Assistance Program

Intervention Type BEHAVIORAL

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.

VA Solid Start

Intervention Type BEHAVIORAL

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.

Interventions

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STEP-Home-SP

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.

Intervention Type BEHAVIORAL

Transition Assistance Program

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.

Intervention Type BEHAVIORAL

VA Solid Start

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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TAP

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine B Fortier, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

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VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Catherine B Fortier, PhD

Role: CONTACT

(857) 364-4361

Facility Contacts

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Catherine B Fortier, PhD

Role: primary

857-364-4361

Other Identifiers

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D4535-R

Identifier Type: -

Identifier Source: org_study_id

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