Clinical trial NCT06378541: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide Prevention
Suicide Attempt
Suicidal Ideation
Keywords: smartphone application
suicide prevention
virtual hope box
veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-04-22
Enrollment: 928
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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

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

Primary outcomes:
measure: 6 month Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS], actual or interrupted)
timeFrame: 6 months
Secondary outcomes:
measure: 6 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Current)
timeFrame: 6 months
measure: 6 month Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] actual attempt)
timeFrame: 6 months
measure: 6 month Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] actual, interrupted, or aborted)
timeFrame: 6-months
measure: 6 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Worst Point)
timeFrame: 6 months
measure: 6 month Suicide attempts (measured by the Suicide Attempt and Self-Injury Count [SASSI-Count], actual attempt)
timeFrame: 6 months
measure: 6 month Suicide attempts (measured by the VA electronic medical record) actual or interrupted or aborted attempt)
timeFrame: 6 months
Other outcomes:
measure: 6 week Self-efficacy to avoid suicidal action (measured by the Self-Efficacy to Avoid Suicidal Action [SEASA] scale)
timeFrame: 6 weeks
measure: 6 week Ability to cope with stressful situations (measured by the Coping Self-Efficacy [CSE]-To Stop Unpleasant Emotions and Thoughts subscale)
timeFrame: 6 weeks
measure: 6 week Reasons to live (measured by the Brief Reasons for Living Inventory [BRFL])
timeFrame: 6 weeks
measure: 3 month Suicide attempts (measured by the Suicide Attempt and Self-Injury Count [SASSI-Count], actual attempt)
timeFrame: 3 months
measure: 3 month Suicide attempts (measured by the VA electronic medical record) actual or interrupted or aborted)
timeFrame: 3 months
measure: 3 month Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS], actual attempt)
timeFrame: 3 months
measure: 3 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Current)
timeFrame: 3 months
measure: 3 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Worst)
timeFrame: 3 months
measure: 3 month Self-efficacy to avoid suicidal action (measured by the Self-Efficacy to Avoid Suicidal Action [SEASA] scale)
timeFrame: 3 months
measure: 3 month Ability to cope with stressful situations (measured by the Coping Self-Efficacy [CSE]-To Stop Unpleasant Emotions and Thoughts subscale)
timeFrame: 3 months
measure: 3 month Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS], actual or interupted)
timeFrame: 3 months
measure: 3 month Reasons to live (measured by the Brief Reasons for Living Inventory [BRFL])
timeFrame: 3 months
measure: 3 month Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS], actual or interrupted or aborted)
timeFrame: 3 months
measure: 6 week Virtual Hope Box (VHB) use frequency
timeFrame: 6 weeks
measure: 6 week VHB app usage Timeline Follow-Back (TLFB)
timeFrame: 6 weeks
measure: Inpatient Phase-VHB app beliefs, usage, and treatment satisfaction
timeFrame: baseline
measure: Remote Phase-VHB app usage
timeFrame: 10 days post-discharge weeks
measure: 6 week Depression symptoms (measured by the Patient Health Questionnaire [PHQ-9])
timeFrame: 6 weeks
measure: 3 month Depression symptoms (measured by the Patient Health Questionnaire [PHQ-9])
timeFrame: 3 months
measure: 6 week Self-reported utilization of health care services
timeFrame: 6 weeks
measure: 3 month Self-reported utilization of health care services
timeFrame: 3 months
measure: 6 week VA medical record attendance in outpatient mental health treatment
timeFrame: 6 weeks
measure: 3 month VA medical record attendance in outpatient mental health treatment
timeFrame: 3 months
measure: Baseline demographics
timeFrame: Baseline
measure: Baseline Alcohol misuse (measured by the Alcohol Use Identification Test [AUDIT])
timeFrame: baseline
measure: Baseline Drug use (measured by the Drug Abuse Screening Test [DAST-10])
timeFrame: baseline
measure: Baseline Anxiety (measured by the Generalized Anxiety Disorder 7 [GAD-7])
timeFrame: baseline
measure: 6 week Coping strategies
timeFrame: 6 weeks
measure: 3 month Virtual Hope Box (VHB) use frequency
timeFrame: 3 months
measure: 3 month Coping strategies
timeFrame: 3 months
measure: 3 month VHB app usage Timeline Follow-Back (TLFB)
timeFrame: 3 months
measure: 6 week Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS], actual or interrupted)
timeFrame: 6 week
measure: 6 weeks Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] actual attempt)
timeFrame: 6 week
measure: 6 week Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] actual, interrupted, or aborted)
timeFrame: 6 weeks
measure: 6 week Suicide attempts (measured by the Suicide Attempt and Self-Injury Count [SASSI-Count], actual attempt)
timeFrame: 6 weeks
measure: 6 week Suicide attempts (measured by the VA electronic medical record) actual or interrupted or aborted attempt)
timeFrame: 6 weeks
measure: 6 week Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Current)
timeFrame: 6 week
measure: 6 week Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Worst)
timeFrame: 6 weeks
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Courtney L Bagge, PhD MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.