STEP Home Workshop for Veteran Reintegration and Suicide Prevention

(SH-SP Trial)

Overseen By Catherine B Fortier, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Active psychosis, High suicide risk, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help veterans adjust to civilian life and prevent suicide during their first year after leaving the military. It will test a workshop called STEP-Home-SP, which teaches emotional regulation and problem-solving skills while offering support to access VA healthcare and reduce social isolation. The trial compares this new approach to the usual care provided to transitioning veterans. Veterans who recently left military service and face challenges adjusting to civilian life may be a good fit for this trial.

As an unphased trial, this study offers veterans a unique opportunity to contribute to research that could significantly improve support systems for others transitioning to civilian life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on providing support and skills for transitioning Veterans, so it's best to discuss your medications with the trial coordinators.

What prior data suggests that the STEP-Home-SP workshop is safe for Veterans?

Research has shown that the STEP-Home-SP workshop helps Veterans adjust to civilian life and reduces the risk of suicide. This program teaches skills such as managing emotions and solving problems. Unlike traditional medical treatments, STEP-Home-SP is a workshop, so it involves no safety concerns related to drugs or medical procedures.

No reports of harm or negative effects have emerged from participating in STEP-Home-SP, indicating that participants receive it well. As an educational and supportive workshop, it emphasizes learning over medical risks. Participants engage in group and individual sessions to ease the transition and enhance mental well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STEP-Home-SP program because it offers a fresh approach to helping veterans reintegrate into civilian life while focusing on suicide prevention. Unlike usual care, which primarily includes standard transition programs, STEP-Home-SP integrates core skills like emotional regulation and problem-solving into veteran-specific modules. This method is further enhanced with attention training and personalized skill-building sessions, potentially offering a more holistic and tailored support system than traditional options. This unique combination of techniques aims to address the complex emotional and psychological needs of veterans more effectively.

What evidence suggests that the STEP-Home-SP workshop is effective for veteran reintegration and suicide prevention?

Research shows that STEP-Home-SP workshops, a treatment option in this trial, can assist Veterans transitioning from military to civilian life. Previous studies have found that these workshops improve skills such as managing emotions and solving problems. These skills can reduce feelings of isolation and facilitate access to VA healthcare. The workshops also provide education on suicide prevention, which is crucial during this sensitive time. Early results suggest that STEP-Home-SP may lower the risk of suicide by supporting Veterans in these key areas. ^{1 2 3 4 5}

Who Is on the Research Team?

Catherine B Fortier, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for recently transitioned Veterans within one year of leaving military service who are facing challenges adapting to civilian life. They must understand English well and agree to participate. Those with active psychosis, immediate high suicide risk, severe substance abuse (except mild cases), or neurological issues other than TBI cannot join.

Inclusion Criteria

Agree to participate (informed consent/HIPAA)

Sufficient English fluency

I left the military service less than a year ago.

Exclusion Criteria

Substance use is a common behavior that may contribute to reintegration difficulties and suicide risk

Participants with mild substance use disorder will be allowed

Active psychosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants engage in the STEP-Home-SP workshop, focusing on emotional regulation, problem solving, and suicide prevention over 12 weeks.

12 weeks

Weekly sessions (virtual)

Follow-up

Participants are monitored for reintegration status, VA care initiation, and other outcomes after the treatment phase.

12 weeks

2 visits (virtual)

Long-term Follow-up

Participants are assessed for long-term outcomes such as suicide risk and psychosocial functioning.

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STEP-Home-SP

Trial Overview

The STEP Home Workshop aims to help these Veterans by providing education on preventing suicide, skills for a smoother transition back into civilian life, support in accessing VA healthcare services, and reducing social isolation which could lower the risk of suicide.

How Is the Trial Designed?

Group I: STEP-Home-SP + Usual Care Experimental Treatment 3 Interventions

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 II: Usual Care Active Control 2 Interventions

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.

STEP-Home-SP is already approved in United States for the following indications:

Approved in United States as STEP-Home-SP for:

• Suicide prevention education for recently transitioned Veterans

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

Individuals with mental illness face a heightened risk of suicide, especially after being discharged from psychiatric hospitalization.

Safety planning intervention (SPI) has shown promising results in emergency departments, but there is a significant gap in research regarding its implementation during psychiatric hospitalization at discharge, indicating a need for more widespread use of SPI in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Planning: Why It Is Essential on the Day of Discharge From In-patient Psychiatric Hospitalization in Reducing Future Risks of Suicide. Schuster, H., Jones, N., Qadri, SF.[2023]

In a study involving 40 veterans, a 3-day filmmaking workshop led to 56% of participants seeking mental health treatment within 4 months, indicating the workshop's potential to encourage treatment engagement.

Participants showed significant reductions in PTSD symptoms at the 1-month follow-up, suggesting that the filmmaking intervention may help improve mental health outcomes and enhance community reintegration for veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot outcomes of a filmmaking intervention designed to enhance treatment entry and social reintegration of veterans. Drebing, CE., Mamon, D., Calixte, RM., et al.[2023]

Peer support groups for veterans transitioning to civilian life have become more popular than visits to mental health professionals, providing essential social support and community integration at no cost.

Research indicates that participation in these groups leads to significant improvements in social support, clinical symptoms, self-efficacy, and coping skills, especially when combined with clinical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using peer support groups to enhance community integration of veterans in transition. Drebing, CE., Reilly, E., Henze, KT., et al.[2020]

The STEP-Home workshop, a 12-week program for OEF/OIF Veterans, was found to be feasible and acceptable, with positive outcomes in skill acquisition related to attention, problem-solving, and emotional regulation.

Veterans who were initially hesitant about mental health treatment showed increased openness to future engagement after participating in the workshop, indicating its potential to improve reintegration and serve as a pathway to further VA services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Skills-Based Group Reintegration Workshop for OEF/OIF Veterans: STEP-Home. Fortier, CB., Kenna, A., Dams-OʼConnor, K., et al.[2022]

The 2-part intervention, which included safety planning and structured telephone follow-up, significantly improved treatment attendance among 95 veterans with a history of suicide-related concerns, compared to their attendance after previous emergency department visits without the intervention.

There was also a trend towards a decrease in hospitalization rates, suggesting that the intervention may help reduce the need for emergency care in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Intervention and Follow-Up for Suicidal Patients With Repeat Emergency Department Visits Enhances Treatment Engagement. Stanley, B., Brown, GK., Currier, GW., et al.[2022]

A randomized controlled trial involving 200 transitioning servicemembers and veterans found that community-based interventions alone did not significantly improve reintegration difficulties or social support compared to a waitlist group.

However, the combination of the Team Red, White, and Blue program with the Expiration Term of Service Sponsorship Program showed better outcomes, indicating that having one-on-one support during reintegration can enhance the effectiveness of community activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting servicemembers and veterans during their transition to civilian life using certified sponsors: A three-arm randomized controlled trial. Geraci, JC., Dichiara, A., Greene, A., et al.[2023]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

The SAFE MIL study is a randomized controlled trial aimed at testing the efficacy of the Safety Planning Intervention for military personnel and their families who are hospitalized for suicidal behavior, with outcomes assessed at one and six months post-discharge.

This research addresses a critical gap in evidence-based suicide prevention programs within the Department of Defense, focusing on a vulnerable population and emphasizing the importance of safety considerations for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Planning for Military (SAFE MIL): rationale, design, and safety considerations of a randomized controlled trial to reduce suicide risk among psychiatric inpatients. Ghahramanlou-Holloway, M., Brown, GK., Currier, GW., et al.[2022]

A 2-hour suicide prevention training for 273 substance use disorder (SUD) treatment providers significantly improved their self-efficacy, knowledge, and practice behaviors related to suicide prevention, with results showing statistical significance (p < .001).

The training, which utilized a video based on a recognized protocol from the Substance Abuse and Mental Health Services Administration, demonstrated high potential for widespread adoption due to its brief duration and ease of implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a suicide prevention training curriculum for substance abuse treatment providers based on Treatment Improvement Protocol Number 50. Conner, KR., Wood, J., Pisani, AR., et al.[2022]

The PACE program, which combines vigorous-intensity exercise with community engagement, aims to support veterans facing challenges during their transition to civilian life.

A randomized controlled trial with 60 participants will assess the feasibility and initial effectiveness of PACE in addressing reintegration difficulties, highlighting the need for community-based interventions for veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Community Engagement (PACE) to facilitate community reintegration among returning veterans: Study protocol for a randomized controlled trial. Baird, SO., Metts, C., Conroy, HE., et al.[2020]

The study will evaluate 'Project Life Force' (PLF), a novel intervention combining skills training and social support with safety planning, to see if it reduces suicidal behavior in high-risk Veterans compared to standard treatment, involving 265 participants in a randomized clinical trial.

The primary focus is on measuring the incidence of suicidal behavior during follow-up, with secondary outcomes assessing factors like depression and coping strategies, highlighting the comprehensive approach to understanding and addressing suicide risk in Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group ("Project Life Force") versus individual suicide safety planning: A randomized clinical trial. Goodman, M., Brown, GK., Galfalvy, HC., et al.[2020]

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We're here anytime, day or night — 24/7

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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 ...

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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 ...

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A Mixed Methods Pilot Trial of the STEP ...

This proposal would bridge this important healthcare gap using STEP-Home-SP, a transdiagnostic, non-stigmatizing, skills-based workshop. STEP- ...