STEP Home Workshop for Veteran Reintegration and Suicide Prevention
(SH-SP Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Active psychosis, High suicide risk, Substance use disorder, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
14678How 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.
19101112Eligibility 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
+1 more
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
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: STEP-Home-SP + Usual CareExperimental Treatment3 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 CareActive Control2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABoston, MA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Group ("Project Life Force") versus individual suicide safety planning: A randomized clinical trial. [2020]One in five suicide deaths is a Veteran and in spite of enhanced suicide prevention services in the Veterans Health Administration (VHA), twenty Veterans die by suicide each day. One component of the VHA's coordinated effort to treat high-risk suicidal Veterans, and diminish suicide risk, is the use of the safety plan. The current study aims to examine a novel intervention integrating skills training and social support with safety planning for Veterans at high-risk for suicide, "Project Life Force" (PLF). A randomized clinical trial (RCT) will be conducted examining if Veterans who are at high-risk for suicide will benefit from the novel group intervention, PLF, compared to Veterans who receive treatment as usual (TAU). We plan to randomize 265 Veterans over the course of the study. The primary outcome variable is the incidence of suicidal behavior, during follow-up, established using a rigorous, multi-method assessment. Secondary outcomes include depression, hopelessness, suicide coping and treatment utilization. Exploratory analyses include safety plan quality and belongingness for those in both arms as well as group cohesion for those in the PLF intervention. Strengths and limitations of this protocol are discussed.
Evaluation of a suicide prevention training curriculum for substance abuse treatment providers based on Treatment Improvement Protocol Number 50. [2022]Substance use disorders (SUDs) confer risk for suicide yet there are no empirically supported suicide prevention training curricula tailored to SUD treatment providers. We assessed the efficacy of a 2-hour training that featured a suicide prevention training video produced by the Department of Veterans Affairs. The video was based on Treatment Improvement Protocol Number 50 (TIP 50) a practical manual to manage suicide risk produced by the Substance Abuse and Mental Health Services Administration. The training was provided in small groups to 273 SUD treatment providers in 18 states. Results were evaluated using self-report assessments obtained at pre-test, post-test, and 2-month follow-up. Statistically significant changes (p
Using peer support groups to enhance community integration of veterans in transition. [2020]Peer support groups, also known as "self-help groups," provide a unique tool for helping veterans working through the military-to-civilian transition to achieve higher levels of social support and community integration. The number and variety of community-based peer support groups has grown to the point that there are now more visits to these groups each year than to mental health professionals. The focus of these groups on the provision of social support, the number and variety of groups, the lack of cost, and their availability in the community make them a natural transition tool for building community-based social support. A growing literature suggests that these groups are associated with measurable improvements in social support, clinical symptoms, self-efficacy and coping. For clinical populations, the combination of peer support groups and clinical care results in better outcomes than either alone. Given this evidence, we suggest clinical services use active referral strategies to help veterans engage in peer support groups as a means of improving community reintegration and clinical outcomes. Finally, suggestions for identifying appropriate peer support groups and assisting with active referrals are provided. (PsycINFO Database Record
The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]The safety planning intervention (SPI) is gaining momentum in suicide prevention practice and research. This systematic review sought to determine the effectiveness of the SPI for adults experiencing suicide-related distress. Systematic searches of international, peer-reviewed literature were conducted in six databases (Cochrane Trials, Embase, Emcare, Medline, PsycINFO and Web of Science), including terms for safety planning, suicide, and suicide-related outcomes. A total of 565 results were included for screening. Result screening (title/abstract and full-text), data extraction and critical appraisal were conducted in duplicate. Twenty-six studies met the inclusion criteria. Studies were primarily quantitative (n = 20), largely with general adult or veteran samples; a small number of studies explored the perspectives of staff and significant others. Half of the studies included the SPI as a standalone intervention, while the other half examined the SPI in combination with other interventions. Most interventions were delivered in-person, with a hard-copy safety plan created, while a smaller number explored internet-based interventions. Primary measures included: suicidality (ideation, behavior, deaths; 10 studies), suicide-related outcomes (depression, hopelessness; 5 studies) and treatment outcomes (hospitalizations, treatment engagement; 7 studies). The evidence supports improvements in each of these domains, with complementary findings from the remaining quantitative and qualitative studies suggesting that the SPI is a feasible and acceptable intervention. While positive, these findings are limited by the heterogeneity of interventions and study designs, making the specific impact of the SPI difficult to both determine and generalize. Conversely, this also points to the flexibility of the SPI.HighlightsThe Safety Planning Intervention (SPI) is a valuable indicated intervention for general adult and veteran populations experiencing suicide-related distress, primarily in face-to-face, clinical settings.Quantitative findings indicate associations between the SPI and improvements in suicidal ideation and behavior, decreases in depression and hopelessness, along with reductions in hospitalizations and improvements in treatment attendance.Qualitative studies suggest the SPI is acceptable and feasible, with areas for development.SPIs have been shown to be adaptable to the clinical area in its modality (digital or paper-based), delivery (face-to-face or online), facilitation (clinician or self-administered) and multiplicity (as stand-alone or combined intervention).
Brief Intervention and Follow-Up for Suicidal Patients With Repeat Emergency Department Visits Enhances Treatment Engagement. [2022]We implemented an innovative, brief, easy-to-administer 2-part intervention to enhance coping and treatment engagement. The intervention consisted of safety planning and structured telephone follow-up postdischarge with 95 veterans who had 2 or more emergency department (ED) visits within 6 months for suicide-related concerns (i.e., suicide ideation or behavior). The intervention significantly increased behavioral health treatment attendance 3 months after intervention, compared with treatment attendance in the 3 months after a previous ED visit without intervention. The trend was for a decreasing hospitalization rate.
Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. [2022]Adverse events (AEs) and serious adverse events (SAEs) are important outcomes of any intervention study yet are under-researched. Vague and variable definitions and substantial underreporting make comparisons of risk between studies difficult and evaluation of the safety of a particular intervention almost impossible. These realities may deter researchers from studying at-risk populations. Suicidal behavior is an adverse event in any study, and potentially a very serious one. Thus the issues of reporting and definition are particularly salient for researchers who work with populations at risk for suicidal behavior, especially when the suicidal behavior is the outcome of interest. We conducted a qualitative study with experienced suicide researchers and intervention experts to delineate the issues related to reporting serious adverse events faced by investigators conducting trials in suicide prevention. Participants from multiple sites were interviewed by phone, interviews transcribed and coded for definition and reporting issues and suggested solutions. A narrative synthesis was prepared and validated by all participants. Participants highlighted the difficulties in defining AEs and SAEs and stressed the importance and complexity of ensuring the AE was related to the study and reported properly, and were in agreement about the consequences of AEs to both institutions and individuals. Participants identified the need for the development of clear and consistent AE definitions and reporting requirements. Clear and consistently applied definitions of adverse and serious adverse events and reporting requirements would enhance the comparability of intervention studies in suicidal populations.
Safety Planning for Military (SAFE MIL): rationale, design, and safety considerations of a randomized controlled trial to reduce suicide risk among psychiatric inpatients. [2022]Mental health related hospitalizations and suicide are both significant public health problems within the United States Department of Defense (DoD). To date, few evidence-based suicide prevention programs have been developed for delivery to military personnel and family members admitted for psychiatric inpatient care due to suicidal self-directed violence. This paper describes the rationale and detailed methodology for a study called Safety Planning for Military (SAFE MIL) which involves a randomized controlled trial (RCT) at the largest military treatment facility in the United States. The purpose of this study is to test the efficacy of a brief, readily accessible, and personalized treatment called the Safety Planning Intervention (Stanley and Brown, 2012). Primary outcomes, measured by blinded assessors at one and six months following psychiatric discharge, include suicide ideation, suicide-related coping, and attitudes toward help seeking. Additionally, given the study's focus on a highly vulnerable patient population, a description of safety considerations for human subjects' participation is provided. Based on this research team's experience, the implementation of an infrastructure in support of RCT research within DoD settings and the processing of regulatory approvals for a clinical trial with high risk suicidal patients are expected to take up to 18-24 months. Recommendations for expediting the advancement of clinical trials research within the DoD are provided in order to maximize cost efficacy and minimize the research to practice gap.
Safety Planning: Why It Is Essential on the Day of Discharge From In-patient Psychiatric Hospitalization in Reducing Future Risks of Suicide. [2023]Individuals who suffer from mental illness are at an increased risk for suicide. That risk is substantially higher in the post-discharge period from psychiatric hospitalization. Safety planning intervention (SPI) is a common intervention tool that is utilized to mitigate the risk of suicide. Current research notes promising results of SPI use in the emergency department (ED); however, there is limited research regarding SPI use during psychiatric hospitalization on the day of discharge. This paper aims to evaluate current research on the topic and establish a need for more widespread use of SPI during psychiatric hospitalization.
Supporting servicemembers and veterans during their transition to civilian life using certified sponsors: A three-arm randomized controlled trial. [2023]Transitioning servicemembers and veterans (TSMVs) face difficulties throughout their reintegration to civilian life, including challenges with employment, poor social connection, and elevated risk for suicide. To meet the needs of this high-risk population, national initiatives have leveraged community-based interventions. Authors conducted a three-arm randomized controlled trial (n = 200) to evaluate two community-based interventions. The first, Team Red, White, and Blue (RWB), connects TSMVs to their community through physical/social activities. The second, Expiration Term of Service Sponsorship Program (ETS-SP) provides one-on-one certified sponsors to TSMVs who provide support during the reintegration process. TSMVs were assessed at baseline, 3, 6, and 12 months. The primary hypothesis was not supported as reintegration difficulties and social support were not significantly different for participants randomly assigned to the two community-based interventions (Arm-2/RWB and Arm-3/RWB + ETS-SP), when the data from the separate arms were collapsed and combined, compared to the waitlist. The results did support the secondary hypothesis as Arm-3/RWB + ETS-SP had less reintegration difficulties over 12 months and initially had more social support compared to Arm-2/RWB, which suggest that augmenting interventions with sponsors outperforms participation in community-based interventions alone. Overall, the results show some limitations of the studied community-based interventions, as implemented and researched within this study. The authors identified factors that may have contributed to the null findings for the primary hypothesis, which can be addressed in future studies, such as addressing the unique needs of TSMVs, enrolling TSMVs into interventions prior to military discharge, measuring and improving participation levels, and providing stepped-care interventions based on risk levels. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
Physical Activity and Community Engagement (PACE) to facilitate community reintegration among returning veterans: Study protocol for a randomized controlled trial. [2020]There is a surprising lack of disseminable, community-based interventions for veterans experiencing difficulties during the reintegration process from military to civilian life. Physical Activity and Community Engagement (PACE) is a program which combines routine vigorous-intensity exercise with community engagement. The program builds on emergent evidence supporting the benefits of routine vigorous-intensity exercise among and establishing social connection. Using a randomized controlled trial (N = 60), we will obtain feasibility data and initial effect sizes for the early effects of PACE on reintegration difficulties.
Feasibility of a Skills-Based Group Reintegration Workshop for OEF/OIF Veterans: STEP-Home. [2022]To evaluate the feasibility of a newly developed reintegration workshop for Operation Iraqi Freedom/Operation Enduring Freedom (OEF/OIF) Veterans that is based on an evidence-based rehabilitation program shown to be effective in treating mild traumatic brain injury-related symptoms in civilians. Underutilization and resistance to mental health treatment remain a significant problem for OEF/OIF Veterans. Innovative, integrative, transdiagnostic, and acceptable interventions are needed, particularly for this heterogeneous group.
Pilot outcomes of a filmmaking intervention designed to enhance treatment entry and social reintegration of veterans. [2023]Military personnel transitioning to civilian life have reported significant challenges in reintegrating into civilian culture. Filmmaking has been used as a therapeutic intervention to enhance the community reintegration of veterans, but there are no published quantitative data documenting its impact. The present study provides outcome data on 40 veterans who participated in the I Was There (IWT) filmmaking workshop. This 3-day (20-hr) group intervention involved veterans working in small teams with a film coach, making short films designed to communicate some aspect of their experience during or after military service, and then creating a screening event to show their films to community members. The sample consisted of community-dwelling veterans who reported at least some mental health symptoms and who were not engaged in mental health treatment for those symptoms. Targeted outcomes included engagement in mental health care, symptoms of posttraumatic stress disorder (PTSD) and depression, and reported perception of community interest in their experience as veterans. Fifty-six percent of participants entered treatment within 4 months of participation. Significant decreases were noted in symptoms of PTSD at 1-month follow-up but not at the 4-month follow-up, while changes in depression were not statistically significant. Participation was related to increased perception of community interest in veterans' experience, and increased interest among community members who viewed the films. These data provide initial support for the conclusion that the IWT film workshop is a potentially effective tool for treatment engagement and for community reintegration among veterans. (PsycInfo Database Record (c) 2023 APA, all rights reserved).