NCT06378541

Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting (Project HOPE)

Virtual Hope Box Enhanced Facilitation in High-Risk Suicidal Veterans

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 928 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test whether a novel intervention, Virtual Hope Box Enhanced Facilitation (VHB-EF), reduces suicide risk in Veterans after discharge from inpatient psychiatric hospitalization. Additionally, this study will also conduct interviews with Veterans and healthcare providers to explore barriers and facilitators to future adoption of the VHB-EF intervention in healthcare settings.

Detailed description

The specific aims of this study are: Aim 1: To evaluate the effects of VHB-EF for reducing suicide behaviors (primary outcome). H1: Suicidal Veterans in the VHB-EF arm will be less likely to have suicide behaviors over the 6 months following enrollment compared to those in the EUC condition. The investigators will also examine the effects of VHB-EF on severity of suicidal ideation (secondary outcome). Aim 2: Examine intervention mechanisms by measuring the effects of VHB-EF on potential mediators, 1) reasons for living, and 2) self-efficacy to (a) cope and (b) refrain from suicide attempts. H2: VHB-EF Veterans will report higher levels of reasons for living and self-efficacy, compared to EUC. Exploratory sub-aim: The investigators will test the hypothesis that higher levels of reasons for living and self-efficacy will partially mediate the effect of VHB-EF on suicide behaviors over 6-months. Furthermore, the investigators will measure the effects of VHB-EF (vs. EUC) on depressive symptoms and healthcare utilization, and their potential role as mediators of outcomes. Aim 3: To examine the determinants (barriers and facilitators) of VHB-EF adoption to inform future implementation and sustainability of VHB-EF across the VA. The investigators will conduct qualitative interviews with providers and Veterans to determine the feasibility and acceptability of VHB-EF. This will be used to refine the intervention to maximize the impact of future implementation. Methods: This is a 2-site randomized effectiveness-implementation hybrid type I trial that will recruit Veterans (N=928) hospitalized for suicidal crises, test this intervention, and gather data to support future implementation. Outcomes will be assessed at 6 weeks, 3 months, and 6 months post-baseline. The study will also include qualitative interviews with providers and Veterans to assess the feasibility and acceptability of VHB-EF. Significance: This innovative study is the first to test the VHB's impact on suicidal behavior in Veterans during high-risk periods following acute care, addressing a key gap in suicide prevention for this vulnerable group.

Conditions

• Suicide Prevention
• Suicide Attempt
• Suicide Ideation

Interventions

Type	Name	Description
BEHAVIORAL	Virtual Hope Box Enhanced Facilitation	The VHB-EF intervention has two phases: (1) The in-person inpatient phase involves a single, one-on-one, 60-minute session delivered by the study interventionist prior to hospital discharge. During this session, the interventionist will obtain access to the participant's personal phone and assist them in downloading the VHB app. The interventionist will provide education about the app and personalized behavioral practice for each component of the app. They will also address strategies to enhance app use. In addition, participants will receive a list of Veteran mental health resources, community services, Veteran service organizations, and other Veteran social support services available to Veterans in the area. (2) The remote-delivery phase builds on the work begun in the hospital via 2 follow-up phone contacts within 14 days following discharge, during which the study interventionist will monitor risk, review/revise VHB content, and support app use and outpatient treatment engagement.
BEHAVIORAL	Enhanced Usual Care	The EUC condition will involve a one-on-one, 30-minute session delivered prior to hospital discharge, during which the study interventionist will review a list of Veteran mental health resources, community services, Veteran service organizations, and other Veteran social support services available to Veterans in the area. The EUC session will remain focused only on reviewing the standardized list of Veteran and community services; no counseling will be provided, and the list provided by the study interventionist does not include non-services (i.e., does not list any smartphone applications, including the VHB app).

Timeline

• Start date: 2025-03-26
• Primary completion: 2028-11-30
• Completion: 2029-05-31
• First posted: 2024-04-22
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States