Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT06378541

Conditions

Suicide Prevention

Suicide Attempt

Suicide Ideation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual Hope Box Enhanced Facilitation

Enhanced Usual Care

Study Details

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.

Conditions

Suicide Prevention

Suicide Attempt

Suicide Ideation

Study ID

NCT06378541

Start date

Mar 26, 2025

Status verified date

Feb, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

928 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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).

Interventions

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.

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Courtney L Bagge, PhD MA

(734) 845-3436Courtney.Bagge@va.gov

Locations

VA Ann Arbor Healthcare System, Ann Arbor, MI

Recruiting

Ann Arbor, Michigan, United States, 48105-2303

Contacts

Fatima Makki, MPH MSW

734-845-3623fatima.makki@va.gov

Principal Investigator:

Courtney L Bagge, PhD MA

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • smartphone application
  • suicide prevention
  • virtual hope box
  • veterans

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-02-09.