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

Official title

Virtual Hope Box Enhanced Facilitation in High-Risk Suicidal Veterans

Overview

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.

Interventions

• 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
• 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 stud

Primary outcome measures

• 6 month Suicide Behaviors (measured by the Columbia Suicide Severity Rating Scale [C-SSRS]) [Time frame: 6 months]

Secondary outcome measures (1)

• 6 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Worst Point) [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

Those enrolled in the RCT component of this study must be:

• 1\) Veterans aged 18 or older
• 2\) admitted to the inpatient psychiatric unit for a recent suicidal crisis
• 3\) medically stable (the patient's medical and psychological fitness \[including aggression\] to provide informed consent will be determined by a member of the patient's treatment team)
• 4\) A score of 3 or greater on the Callahan 6-item cognitive screening.
• 5\) report current suicidal ideation (Scale for Suicidal Ideation \[SSI\]; sum of items 4 and 5 > 0, referencing the week prior to their hospitalization) as reported during the screening interview
• 6\) no reported use of the VHB within the past 12-months
• 7\) access to a smartphone to download the VHB app

Exclusion criteria

Veterans will be found ineligible for the program if:

• 1\) do not understand English
• 2\) are prisoners
• 3\) are unable to provide informed consent
• 4\) have profound psychotic symptoms and/or cognitive deficits that would prevent patients from understanding the content of the intervention and/or assessments
• 5\) to not have access to a smartphone

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 1 center

• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor

Publications

• Gerner JL, Tucker RP, Moscardini EH, Bagge CL, Reger MA. The Virtual Hope Box mobile application: A systematic review of the literature. Suicide Life Threat Behav. 2024 Jun;54(3):501-514. doi: 10.1111/sltb.13061. Epub 2024 Feb 21. PMID 38380558

Identifiers

NCT: NCT06378541 · SDR 21-267

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗