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NCT Number: NCT06378541

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location status: Recruiting

Location contact

Courtney L Bagge, PhD MA

PRINCIPAL_INVESTIGATOR

Fatima Makki, MPH MSW

CONTACT

[email protected]

734-845-3623

Mark A. Ilgen, PhD

SUB_INVESTIGATOR

Paul N Pfeiffer, MD MS

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Hope Box Enhanced Facilitation

Behavioral

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

Enhanced Usual Care

Behavioral

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

Primary outcomes

  1. 6 month Suicide Behaviors (measured by the Columbia Suicide Severity Rating Scale [C-SSRS])

    Time frame: 6 months

    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.

Secondary outcomes

  1. 6 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Worst Point)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Courtney L Bagge, PhD MA

CONTACT

[email protected]

(734) 845-3436

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Virtual Hope Box Enhanced Facilitation in High-Risk Suicidal Veterans

Acronym: Project HOPE

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 22, 2024
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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