Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting (Project HOPE) (Project HOPE)
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ClinicalTrials.gov Identifier: NCT06378541 |
Recruitment Status :
Not yet recruiting
First Posted : April 22, 2024
Last Update Posted : April 22, 2024
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Condition or disease | Intervention/treatment | Phase |
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Suicide Prevention Suicide Attempt Suicidal Ideation | Behavioral: Virtual Hope Box Enhanced Facilitation Behavioral: Enhanced Usual Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 928 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Virtual Hope Box Enhanced Facilitation in High-Risk Suicidal Veterans |
Estimated Study Start Date : | November 1, 2024 |
Estimated Primary Completion Date : | October 31, 2028 |
Estimated Study Completion Date : | October 31, 2028 |
Arm | Intervention/treatment |
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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.
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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 |
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).
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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 |
- 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.
- 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.
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06378541
Contact: Courtney L Bagge, PhD MA | (734) 845-3436 | Courtney.Bagge@va.gov |
United States, Michigan | |
VA Ann Arbor Healthcare System, Ann Arbor, MI | |
Ann Arbor, Michigan, United States, 48105-2303 | |
Contact: Fatima Makki, MPH MSW 734-845-3623 fatima.makki@va.gov | |
Principal Investigator: Courtney L Bagge, PhD MA | |
United States, Washington | |
VA Puget Sound Health Care System Seattle Division, Seattle, WA | |
Seattle, Washington, United States, 98108-1532 | |
Contact: Mark Reger, PhD 253-583-3295 Mark.Reger@va.gov |
Principal Investigator: | Courtney L Bagge, PhD MA | VA Ann Arbor Healthcare System, Ann Arbor, MI |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT06378541 |
Other Study ID Numbers: |
SDR 21-267 |
First Posted: | April 22, 2024 Key Record Dates |
Last Update Posted: | April 22, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
smartphone application suicide prevention virtual hope box veterans |
Suicide Suicidal Ideation Suicide Prevention |
Suicide, Attempted Self-Injurious Behavior Behavioral Symptoms |