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

Not Applicable

Not yet recruiting

• Conditions: Suicide Prevention; Suicide Attempt; Suicidal Ideation
• Interventions: Behavioral: Virtual Hope Box Enhanced Facilitation; Behavioral: Enhanced Usual Care

• Registration Number: NCT06378541
• Lead Sponsor: VA Office of Research and Development

Brief 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

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). Notably, different conceptualizations and measurements of suicide attempt are being evaluated.

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.

Study Timeline

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-26
• Study Start: 2025-01-02
• Primary Completion: 2028-10-31
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 928

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 self-diagnosed recent suicidal crisis in intake notes
• 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 on the Callahan 6-item cognitive screening.

Additional inclusion criteria for the full baseline and follow-up portions of the study include:

• 1. 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
• 2. no reported use of the VHB within the past 12-months
• 3. own a smartphone to download the VHB app

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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. do not own a smartphone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Hope Box Enhanced Facilitation (VHB-EF)	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 Therapist prior to hospital discharge. During this session, the therapist will obtain access to the participant's personal phone and assist them in downloading the VHB app. The therapist 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. (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 therapist will monitor risk, review/revise VHB content, and support app use and outpatient treatment engagement.
Enhanced Usual Care (EUC)	Enhanced Usual Care	The EUC condition will involve a one-on-one, 30-minute session delivered by the Study Therapist prior to hospital discharge, during which the therapist will review mental health resources 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 therapist does not include non-services (i.e., does not list any smartphone applications, including the VHB app).

Primary Outcome Measures

Name	Time	Method
6 month Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS], actual or interrupted)	6 months	Suicide attempts will be measured by the C-SSRS and will be administered as a semi-structured interview. The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt or interrupted suicide attempt during the specified time period.

Secondary Outcome Measures

Name	Time	Method
6 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Current)	6 months	Current severity of suicidal ideation will be measured by the Scale for Suicidal Ideation (SSI) interview. The total score (sum of the first 19 items) will be used. Scores range from 0 to 38. Increasing scores reflect greater suicide risk.
6 month Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] actual attempt)	6 months	Suicide attempts will be measured by the C-SSRS and will be administered as a semi-structured interview. The definition of suicide attempt will consist of any actual suicide attempt during the specified time period.
6 month Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] actual, interrupted, or aborted)	6-months	Suicide attempts will be measured by the C-SSRS and will be administered as a semi-structured interview. The definition of suicide attempt will consist of any actual suicide attempt or interrupted suicide attempt or aborted suicide attempt during the specified time period.
6 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Worst Point)	6 months	Worst-point severity of suicidal ideation will be measured by the Scale for Suicidal Ideation (SSI) interview. The total score (sum of the first 19 items) will be used. Scores range from 0 to 38. Increasing scores reflect greater suicide risk.
6 month Suicide attempts (measured by the Suicide Attempt and Self-Injury Count [SASSI-Count], actual attempt)	6 months	Suicide attempts will be measured by the SASSI-Count and will be administered as a semi-structured interview. The definition of suicide attempt will consist of any actual suicide attempt during the specified time period.
6 month Suicide attempts (measured by the VA electronic medical record) actual or interrupted or aborted attempt)	6 months	Suicide attempts will be measured by documentation via the VA electronic medical record. The definition of suicide attempt will consist of any actual suicide attempt, interrupted, or aborted suicide attempt during the specified time period.

Trial Locations

Locations (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI; 🇺🇸 Ann Arbor, Michigan, United States