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

Virtual Hope Box Enhanced Facilitation in High-Risk Suicidal Veterans

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.

Study Overview

• Status: Recruiting
• Conditions: Suicide Attempt; Suicide Ideation; Suicide Prevention
• Intervention / Treatment: Behavioral: Virtual Hope Box Enhanced Facilitation; Behavioral: Enhanced Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 928
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Courtney L Bagge, PhD MA; Phone Number: (734) 845-3436; Email: Courtney.Bagge@va.gov

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105-2303
      • Recruiting
      • VA Ann Arbor Healthcare System, Ann Arbor, MI
      • Sub-Investigator: Mark A. Ilgen, PhD
      • Contact: Fatima Makki, MPH MSW; Phone Number: 734-845-3623; Email: fatima.makki@va.gov
      • Sub-Investigator: Paul N Pfeiffer, MD MS
      • Principal Investigator: Courtney L Bagge, PhD MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Hope Box Enhanced Facilitation (VHB-EF); 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 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. (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: 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.; Other Names: VHB-EF
Active Comparator: Enhanced Usual Care (EUC); The EUC condition will involve a one-on-one, 30-minute session delivered by the study interventionist prior to hospital discharge, during which the interventionist will review 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).	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).; Other Names: EUC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Worst Point)	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 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 week Self-efficacy to avoid suicidal action (measured by the Self-Efficacy to Avoid Suicidal Action [SEASA] scale)	Participants' self-efficacy to avoid suicidal action will be measured by the Self-Efficacy to Avoid Suicidal Action (SEASA) scale. Each item is scored on a 0-9 scale from "very uncertain" to "very certain" to indicate level of confidence. Prior studies have found that lower scores on the SEASA are associated with a higher incidence and greater severity of suicide attempts.	6 weeks
6 week Ability to cope with stressful situations (measured by the Coping Self-Efficacy [CSE]-To Stop Unpleasant Emotions and Thoughts subscale)	Participants' coping self-efficacy will be measured by the Coping Self-Efficacy (CSE) Stopping Unpleasant Emotions and Thoughts subscale. Respondents rate each item on a scale from 0 (cannot do at all) to 10 (certain can do). Scores range from 0 to 40. Higher scores represent greater coping self-efficacy.	6 weeks
6 week Reasons to live (measured by the Brief Reasons for Living Inventory [BRFL])	The Brief Reasons for Living Inventory (BRFL) is a 12-item self-report measure in which the participant rates each item in terms of its importance to them (1 - not at all important; 6 - extremely important). Scores range from 12 to 72. Higher scores indicate greater reasons for living.	6 weeks
3 month Suicide attempts (measured by the Suicide Attempt and Self-Injury Count [SASSI-Count], actual attempt)	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.	3 months
3 month Suicide attempts (measured by the VA electronic medical record) actual or interrupted or aborted)	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.	3 months
3 month Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS], actual attempt)	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.	3 months
3 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Current)	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.	3 months
3 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Worst)	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.	3 months
3 month Self-efficacy to avoid suicidal action (measured by the Self-Efficacy to Avoid Suicidal Action [SEASA] scale)	Participants' self-efficacy to avoid suicidal action will be measured by the Self-Efficacy to Avoid Suicidal Action (SEASA) scale. Each item is scored on a 0-9 scale from "very uncertain" to "very certain" to indicate level of confidence. Prior studies have found that lower scores on the SEASA are associated with a higher incidence and greater severity of suicide attempts.	3 months
3 month Ability to cope with stressful situations (measured by the Coping Self-Efficacy [CSE]-To Stop Unpleasant Emotions and Thoughts subscale)	Participants' coping self-efficacy will be measured by the Coping Self-Efficacy (CSE) Stopping Unpleasant Emotions and Thoughts subscale. Respondents rate each item on a scale from 0 (cannot do at all) to 10 (certain can do). Scores range from 0 to 40. Higher scores represent greater coping self-efficacy.	3 months
3 month Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS], actual or interupted)	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 during the specified time period.	3 months
3 month Reasons to live (measured by the Brief Reasons for Living Inventory [BRFL])	The Brief Reasons for Living Inventory (BRFL) is a 12-item self-report measure in which the participant rates each item in terms of its importance to them (1 - not at all important; 6 - extremely important). Scores range from 12 to 72. Higher scores indicate greater reasons for living.	3 months
3 month Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS], actual or interrupted or aborted)	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, interrupted, or aborted suicide attempt during the specified time period.	3 months
6 week Virtual Hope Box (VHB) use frequency	Participants will self-report the frequency of their VHB mental health app usage using the Smartphone App Questionnaire, which ranges from 0(never) to 7 (every day). Higher scores indicate higher usage.	6 weeks
6 week VHB app usage Timeline Follow-Back (TLFB)	Participants will report the days that they used the VHB app during the specified time period. A TLFB procedure will be used. Possible ranges include 0=never to # of possible days in the 6 week assessment.	6 weeks
Inpatient Phase-VHB app beliefs, usage, and treatment satisfaction	The VHB-EF treatment group will complete a brief self-report questionnaire during the inpatient treatment session. This will ask pre-post session questions regarding their use of the VHB app. It also asks questions regarding participant satisfaction. This measure was created by the investigative team.	baseline
Remote Phase-VHB app usage	The VHB-EF treatment group will complete a brief self-report questionnaire regarding their use of the VHB app during the remote phase of the intervention. This measure was created by the investigative team.	10 days post-discharge weeks
6 week Depression symptoms (measured by the Patient Health Questionnaire [PHQ-9])	The Patient Health Questionnaire (PHQ-9) is a self-report measure where higher scores represent greater symptoms of depression. Scores range from 0 to 27.	6 weeks
3 month Depression symptoms (measured by the Patient Health Questionnaire [PHQ-9])	The Patient Health Questionnaire (PHQ-9) is a self-report measure where higher scores represent greater symptoms of depression. Scores range from 0 to 27.	3 months
6 week Self-reported utilization of health care services	Self-reported health services used will be assessed by an adapted version of the Health Services Inventory	6 weeks
3 month Self-reported utilization of health care services	Self-reported health services used will be assessed by an adapted version of the Health Services Inventory.	3 months
6 week VA medical record attendance in outpatient mental health treatment	Attendance in outpatient mental health treatment will be assessed by the VA medical record.	6 weeks
3 month VA medical record attendance in outpatient mental health treatment	Attendance in outpatient mental health treatment will be assessed by the VA medical record.	3 months
Baseline demographics	We will use the demographic measure within the PhenX Tool Kit to measure participants' age, gender, race, ethnicity, marital status, education, and annual family income	Baseline
Baseline Alcohol misuse (measured by the Alcohol Use Identification Test [AUDIT])	The AUDIT is a self-report measure that assesses alcohol intake and potential abuse. Scores greater to or equal to 8 indicate problematic alcohol use.	baseline
Baseline Drug use (measured by the Drug Abuse Screening Test [DAST-10])	DAST-10 is a screening tool consisting of 10 Yes/No questions that assess drug use problems. Potential scores range from 0 to 10. Higher scores represent greater problematic use.	baseline
Baseline Anxiety (measured by the Generalized Anxiety Disorder 7 [GAD-7])	The GAD-7 is a 7-item self-report measure that assesses generalized anxiety symptoms. Scores range from 0 to 21. Higher scores represent greater anxiety.	baseline
6 week Coping strategies	Presence of self-reported coping strategies used will be assessed by an adapted version of the Brief Cope.	6 weeks
3 month Virtual Hope Box (VHB) use frequency	Participants will self-report the frequency of their VHB mental health app usage using the Smartphone App Questionnaire, which ranges from 0(never) to 7 (every day). Higher scores indicate higher usage.	3 months
3 month Coping strategies	Presence of self-reported coping strategies used will be assessed by an adapted version of the Brief Cope.	3 months
3 month VHB app usage Timeline Follow-Back (TLFB)	Participants will report the days that they used the VHB app during the specified time period. A TLFB procedure will be used. Possible ranges include 0=never to # of possible days in the assessment.	3 months
6 week Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS], actual or interrupted)	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.	6 week
6 weeks Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] actual attempt)	Suicide attempts will be measured by the C-SSRS and will be administered as a semi-structured interview. The definition of suicide attempt f will consist of any actual suicide attempt during the specified time period.	6 week
6 week Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] actual, interrupted, or aborted)	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, interrupted, or aborted suicide attempt during the specified time period.	6 weeks
6 week Suicide attempts (measured by the Suicide Attempt and Self-Injury Count [SASSI-Count], actual attempt)	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 weeks
6 week Suicide attempts (measured by the VA electronic medical record) actual or interrupted or aborted attempt)	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.	6 weeks
6 week Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Current)	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 week
6 week Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Worst)	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 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Courtney L Bagge, PhD MA, VA Ann Arbor Healthcare System, Ann Arbor, MI

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: veterans; smartphone application; suicide prevention; virtual hope box
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Behavior; Suicide Prevention; Suicide, Attempted
• Other Study ID Numbers: SDR 21-267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No