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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment STEP-Home-SP for veteran reintegration and suicide prevention?

Research shows that safety planning interventions, which are part of the STEP-Home-SP treatment, are effective in reducing suicidal thoughts and behaviors, as well as depression and hopelessness in veterans. Additionally, peer support groups, similar to those used in STEP-Home-SP, have been shown to improve social support and community integration for veterans. ^{1 2 3 4 5}

Is the STEP Home Workshop for Veteran Reintegration and Suicide Prevention safe for humans?

The Safety Planning Intervention (SPI), which is similar to the STEP Home Workshop, has been shown to be generally safe and acceptable for adults, including veterans, experiencing suicide-related distress. Studies indicate that SPI is feasible and adaptable, with no significant safety concerns reported. ^{1 4 6 7 8}

How is the STEP-Home-SP treatment different from other treatments for veteran reintegration and suicide prevention?

The STEP-Home-SP treatment is unique because it is a skills-based group workshop specifically designed for veterans, drawing from a successful rehabilitation program for mild traumatic brain injury in civilians. This approach is innovative and integrative, aiming to address the diverse needs of veterans who may be resistant to traditional mental health treatments. ^{1 9 10 11 12}

Research Team

Catherine B Fortier, PhD

Principal Investigator

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

Eligibility Criteria

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)

I left the military service less than a year ago.

Sufficient English fluency

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Group ("Project Life Force") versus individual suicide safety planning: A randomized clinical trial. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a suicide prevention training curriculum for substance abuse treatment providers based on Treatment Improvement Protocol Number 50. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Using peer support groups to enhance community integration of veterans in transition. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Brief Intervention and Follow-Up for Suicidal Patients With Repeat Emergency Department Visits Enhances Treatment Engagement. [2022]

6. England 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. [2022]

7. United States 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. [2022]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Supporting servicemembers and veterans during their transition to civilian life using certified sponsors: A three-arm randomized controlled trial. [2023]

10. Netherlands 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. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Skills-Based Group Reintegration Workshop for OEF/OIF Veterans: STEP-Home. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Pilot outcomes of a filmmaking intervention designed to enhance treatment entry and social reintegration of veterans. [2023]