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

Suicidal Ideation Clinical Trial

Official title: Virtual Hope Box Enhanced Facilitation in High-Risk Suicidal Veterans

Status Not yet recruiting

Clinical Trial Summary

This study will test whether a new 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.

Clinical Trial Description

Background: Veteran suicide prevention is a top national priority, with Veterans experiencing suicide rates 1.5 times higher than the general population. Suicide rates are especially high among Veterans recently discharged from inpatient mental health units. The Virtual Hope Box (VHB) app, developed by the Department of Defense (DoD), aims to improve access to an intervention used in evidence-based suicide prevention treatments. The VHB app provides users with instant access to suicide prevention resources and coping tools, and is routinely cited as a top evidence-based mental health app, and has been nationally disseminated in the Veterans Health Administration (VHA) and DoD. Despite this, its efficacy in suicide prevention remains under-evidenced, and its reach among high-risk Veterans is limited.

To address these concerns, the investigators developed the VHB-EF intervention. VHB-EF has two phases: (1) the in-person inpatient phase involves a single session that assists the Veteran with downloading and using the VHB app, provides personalization and behavioral practice for each component of the app, and addresses strategies to enhance app use; (2) the remote-delivery phase includes two follow-up phone contacts following hospital discharge to monitor suicide risk, review and/or revise VHB content, and support app use and outpatient treatment engagement. The investigators hypothesize that VHB-EF will bolster reasons for living and increase self-efficacy to cope and refrain from suicide attempts, which will in turn reduce suicide attempts.

The specific aims of this study are:

Aim 1: To evaluate the effects of VHB-EF for reducing suicide attempts (primary outcome).

H1: Suicidal Veterans in the VHB-EF arm will be less likely to have a suicide attempt 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 attempts 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. ;

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide Attempt
• Suicide Prevention
• Suicide, Attempted

• NCT number: NCT06378541
• Study type: Interventional
• Source: VA Office of Research and Development
• Contact: Courtney L Bagge, PhD MA
• Phone: (734) 845-3436
• Email: Courtney.Bagge@va.gov
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Completion date: October 31, 2028