NCT06378541

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
928

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Mar 2025May 2029

First Submitted

Initial submission to the registry

April 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

March 26, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

April 15, 2024

Last Update Submit

February 4, 2026

Conditions

Keywords

smartphone applicationsuicide preventionvirtual hope boxveterans

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    6 months

Study Arms (2)

Virtual Hope Box Enhanced Facilitation (VHB-EF)

EXPERIMENTAL

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

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: VHB-EF
Virtual Hope Box Enhanced Facilitation (VHB-EF)

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).

Also known as: EUC
Enhanced Usual Care (EUC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those enrolled in the RCT component of this study must be:
  • \) Veterans aged 18 or older
  • \) admitted to the inpatient psychiatric unit for a recent suicidal crisis
  • \) 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)
  • \) A score of 3 or greater on the Callahan 6-item cognitive screening.
  • \) 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
  • \) no reported use of the VHB within the past 12-months
  • \) access to a smartphone to download the VHB app

You may not qualify if:

  • Veterans will be found ineligible for the program if:
  • \) do not understand English
  • \) are prisoners
  • \) are unable to provide informed consent
  • \) have profound psychotic symptoms and/or cognitive deficits that would prevent patients from understanding the content of the intervention and/or assessments
  • \) to not have access to a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

RECRUITING

Related Publications (1)

  • 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: 38380558BACKGROUND

MeSH Terms

Conditions

Suicide PreventionSuicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Courtney L Bagge, PhD MA

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney L Bagge, PhD MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 22, 2024

Study Start

March 26, 2025

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

May 31, 2029

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations