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

• ClinicalTrials.gov Identifier: NCT06378541
• Recruitment Status: Not yet recruiting
• First Posted: April 22, 2024
• Last Update Posted: April 22, 2024
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: April 15, 2024
• First Posted Date: April 22, 2024
• Last Update Posted Date: April 22, 2024
• Estimated Study Start Date: November 1, 2024
• Estimated Primary Completion Date: October 31, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 17, 2024)

Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] and medical chart review) [ Time Frame: Change from baseline to 6-months ]

Suicide attempts will be measured at baseline and follow-ups using using the Colombia Suicide Severity Rating Scale (C-SSRS), administered as a semi-structured interview. We will assess the number and types of suicide attempts (actual, interrupted, and aborted). The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt and/or interrupted suicide attempt during the specified time period according to the C-SSRS. This self-report measure will be supplemented by an Electronic Health Record (EHR) abstraction of participants' VHA records from baseline through 2.5 years after participant ends to collect information regarding suicide attempts.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 17, 2024)

Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]) [ Time Frame: Baseline, 6-weeks, 3-months, 6-months, 36 months ]

The Scale for Suicidal Ideation (SSI) is an interview of suicidal ideation and past suicide attempts, that is part of the PhenX Tool Kit (items range from 0 to 2). Severity of suicidal ideation is associated with a greater risk of suicide. At baseline, the SSI will be administered prior to enrollment as an eligibility screening measure. A score >0 (sum of items 4 + 5) will be used as the cut-off during screening. At baseline and follow-up, the total score (sum of first 19 items) will assess severity of suicidal ideation. This self-report measure will be supplemented by an Electronic Health Record (EHR) abstraction of participants' VHA records from baseline through 2.5 years after participant ends to collect information regarding suicidal ideation.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: April 17, 2024)

• Self-efficacy to resist a future suicide attempt (measured by the Self-Efficacy to Avoid Suicidal Action [SEASA] scale) [ Time Frame: Baseline, 6-weeks, 3-months, 6-months ]
  The Self-Efficacy to Avoid Suicidal Action (SEASA) scale is a 6-item self-report measure. Each item is scored on a 0-9 scale from "very uncertain" to "very certain."
• Ability to cope with stressful situations (measured by the Coping Self-Efficacy [CSE] scale) [ Time Frame: Baseline, 6-weeks, 3-months, 6-months ]
  The Coping Self-Efficacy (CSE) scale is a self-report measure that uses a scale rating from 0 (cannot do at all) to 10 (certain can do). The CSE has shown reliability and validity in depressed samples and can be used to assess change in coping ability over time.
• Reasons to live (measured by the Brief Reasons for Living Inventory [BRFL]) [ Time Frame: Baseline, 6-weeks, 3-months, 6-months ]
  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).
• Depression symptoms (measured by the Patient Health Questionnaire [PHQ-9]) [ Time Frame: Baseline, 6-weeks, 3-months, 6-months ]
  The Patient Health Questionnaire (PHQ-9) is a 9-item self-report instrument where the total score will be used for measuring the severity of depressive symptoms over the past 2 weeks.
• Mental Health Treatment Utilization (measured by the Treatment Services Review [TSR]) [ Time Frame: Baseline, 6-weeks, 3-months, 6-months, 36 months ]
  Information on treatment will be collected including whether a participant has received specific types of treatment, how many times a participant utilized the service, and whether they received the service within a specified period of time (at baseline) or during the assessment period (at follow-up). This includes all treatment regardless of if it is within the VHA system. This self-report measure will be supplemented by an Electronic Health Record (EHR) abstraction of participants' VHA records from baseline through 2.5 years after participant ends to collect information regarding inpatient mental health admissions and outpatient mental health service utilization.
• Demographics [ Time Frame: Baseline ]
  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.
• Borderline personality disorder features (measured by the Personality Assessment Inventory-Borderline Features Scale [PAI-BOR]) [ Time Frame: Baseline, 6-weeks, 3-months, 6-months ]
  The PAI-BOR is a self-report measure that assesses features of Borderline Personality Disorder.
• Alcohol misuse (measured by the Alcohol Use Identification Test [AUDIT]) [ Time Frame: Baseline, 6-weeks, 3-months, 6-months ]
  The AUDIT is a self-report measure that assesses alcohol intake and potential abuse.
• Drug use (measured by the Drug Abuse Screening Test [DAST-10]) [ Time Frame: Baseline, 6-weeks, 3-months, 6-months ]
  DAST-10 is a screening tool consisting of 10 Yes/No questions that assess drug use problems.
• Anxiety (measured by the Generalized Anxiety Disorder 7 [GAD-7]) [ Time Frame: Baseline, 6-weeks, 3-months, 6-months ]
  The GAD-7 is a 7-item self-report measure that assesses generalized anxiety symptoms.
• Coping strategies (measured by the Brief-COPE scale) [ Time Frame: Baseline, 6-weeks, 3-months, 6-months ]
  The Brief-COPE is a 28-item self-report measure to assess coping strategies.
• Virtual Hope Box (VHB) frequency [ Time Frame: Baseline, 6-weeks, 3-months, 6-months ]
  Participants will self-report the frequency of their mental health app use separately for three mental health apps, including the VHB app, at baseline and follow-ups using the Smartphone App Questionnaire, a self-report measure that uses a Likert scale from 0 (never) to 6 (every day). Mental Health App Timeline Followback (TLFB) will also be used to assess the frequency of VHB usage (and two other mental health apps). We will use modified Timeline Followback methodology to collect daily assessments of app usage at all follow-ups.
• VHB app beliefs, usage, and treatment satisfaction [ Time Frame: Baseline ]
  The VHB-EF 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 and have open-ended responses for feedback. The VHB-EF group will also be asked questions regarding their VHB app use during the remote phase of the VHB-EF. This measure was created by the investigative team.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting (Project HOPE)
• Official Title: Virtual Hope Box Enhanced Facilitation in High-Risk Suicidal Veterans
• Brief Summary: This study will test whether a new 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

Background: Veteran suicide prevention is a top national priority, with Veterans experiencing suicide rates 1.5 times higher than the general population. Suicide rates are especially high among Veterans recently discharged from inpatient mental health units. The Virtual Hope Box (VHB) app, developed by the Department of Defense (DoD), aims to improve access to an intervention used in evidence-based suicide prevention treatments. The VHB app provides users with instant access to suicide prevention resources and coping tools, and is routinely cited as a top evidence-based mental health app, and has been nationally disseminated in the Veterans Health Administration (VHA) and DoD. Despite this, its efficacy in suicide prevention remains under-evidenced, and its reach among high-risk Veterans is limited.

To address these concerns, the investigators developed the VHB-EF intervention. VHB-EF has two phases: (1) the in-person inpatient phase involves a single session that assists the Veteran with downloading and using the VHB app, provides personalization and behavioral practice for each component of the app, and addresses strategies to enhance app use; (2) the remote-delivery phase includes two follow-up phone contacts following hospital discharge to monitor suicide risk, review and/or revise VHB content, and support app use and outpatient treatment engagement. The investigators hypothesize that VHB-EF will bolster reasons for living and increase self-efficacy to cope and refrain from suicide attempts, which will in turn reduce suicide attempts.

The specific aims of this study are:

Aim 1: To evaluate the effects of VHB-EF for reducing suicide attempts (primary outcome).

H1: Suicidal Veterans in the VHB-EF arm will be less likely to have a suicide attempt 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 attempts 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Suicide Prevention
• Suicide Attempt
• Suicidal Ideation

Intervention

• 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 Therapist prior to hospital discharge. During this session, the therapist will obtain access to the participant's personal phone and assist them in downloading the VHB app. The therapist 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. (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 therapist will monitor risk, review/revise VHB content, and support app use and outpatient treatment engagement.
  Other Name: VHB-EF
• 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 staff member will review mental health resources 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 staff member does not include non-services (i.e., does not list any smartphone applications, including the VHB app).
  Other Name: EUC

Study 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 Therapist prior to hospital discharge. During this session, the therapist will obtain access to the participant's personal phone and assist them in downloading the VHB app. The therapist 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. (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 therapist will monitor risk, review/revise VHB content, and support app use and outpatient treatment engagement.
  Intervention: Behavioral: Virtual Hope Box Enhanced Facilitation
• Active Comparator: Enhanced Usual Care (EUC)
  The EUC condition will involve a one-on-one, 30-minute session delivered by the Study Therapist prior to hospital discharge, during which the therapist will review mental health resources 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 therapist does not include non-services (i.e., does not list any smartphone applications, including the VHB app).
  Intervention: Behavioral: Enhanced Usual Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 17, 2024): 928
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2028
• Estimated Primary Completion Date: October 31, 2028 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 self-diagnosed recent suicidal crisis in intake notes
• 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 on the Callahan 6-item cognitive screening.

Additional inclusion criteria for the full baseline and follow-up portions of the study include:

• 1) 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
• 2) no reported use of the VHB within the past 12-months
• 3) own 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) do not own a smartphone

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Courtney L Bagge, PhD MA; (734) 845-3436; Courtney.Bagge@va.gov

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06378541
• Other Study ID Numbers: SDR 21-267
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: VA Office of Research and Development
• Original Responsible Party: Same as current
• Current Study Sponsor: VA Office of Research and Development
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Courtney L Bagge, PhD MA; VA Ann Arbor Healthcare System, Ann Arbor, MI

• PRS Account: VA Office of Research and Development
• Verification Date: April 2024