Suicide PreventionProject HOPENCT06378541
Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting (Project HOPE)
A study testing Virtual Hope Box Enhanced Facilitation in people with Suicide Prevention and Suicide Attempt, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Prevention, Suicide Attempt, Suicide Ideation
- What is being tested?
- Virtual Hope Box Enhanced Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 928 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2025to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Fatima Makki, MPH MSW, 734-845-3623, fatima.makki@va.gov
Courtney L Bagge, PhD MA
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide Prevention, Suicide Attempt, Suicide Ideation
- Being tested
- Virtual Hope Box Enhanced Facilitation, Enhanced Usual Care
- Keywords
- smartphone application, suicide prevention, virtual hope box, veterans
- Medical subject headings
- Suicide Prevention, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Hope Box Enhanced FacilitationBehavioural
Also called 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 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 CareBehavioural
Also called EUC
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start26 Mar 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 928 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Courtney L Bagge, PhD MA, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378541
- Sponsor's protocol ID
- SDR 21-267
- Acronym
- Project HOPE
- Status last verified
- Feb 2026
- First submitted
- 15 Apr 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38380558
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Hope Box Enhanced Facilitation in High-Risk Suicidal Veterans
- ClinicalTrials.gov ID
- NCT06378541
- Acronym / sponsor ID
- Project HOPE / SDR 21-267
- Conditions
- Suicide Prevention, Suicide Attempt, Suicide Ideation
- Keywords
- smartphone application, suicide prevention, virtual hope box, veterans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 928 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Hope Box Enhanced Facilitation (VHB-EF) | Experimental | Behavioral: Virtual Hope Box Enhanced FacilitationThe 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. |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual CareThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Hope Box Enhanced FacilitationAlso: VHB-EFThe 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. | Behavioural | Virtual Hope Box Enhanced Facilitation (VHB-EF) |
| Enhanced Usual CareAlso: EUCThe 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). | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
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.
1 secondary outcome
6 month Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]-Worst Point)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background: PubMed 38380558Gerner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Courtney L Bagge, PhD MA principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Hope Box Enhanced Facilitation in people with Suicide Prevention and Suicide Attempt, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney L Bagge, PhD MA ((734) 845-3436, Courtney.Bagge@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 month Suicide Behaviors (measured by the Columbia Suicide Severity Rating Scale [C-SSRS]) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06378541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.