Suicidal Ideation Clinical Trial
— Project HOPEOfficial title:
Virtual Hope Box Enhanced Facilitation in High-Risk Suicidal Veterans
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.
Status | Not yet recruiting |
Enrollment | 928 |
Est. completion date | October 31, 2028 |
Est. primary completion date | October 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan |
United States | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Self-efficacy to resist a future suicide attempt (measured by the Self-Efficacy to Avoid Suicidal Action [SEASA] scale) | 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." | Baseline, 6-weeks, 3-months, 6-months | |
Other | Ability to cope with stressful situations (measured by the Coping Self-Efficacy [CSE] scale) | 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. | Baseline, 6-weeks, 3-months, 6-months | |
Other | Reasons to live (measured by the Brief Reasons for Living Inventory [BRFL]) | 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). | Baseline, 6-weeks, 3-months, 6-months | |
Other | Depression symptoms (measured by the Patient Health Questionnaire [PHQ-9]) | 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. | Baseline, 6-weeks, 3-months, 6-months | |
Other | Mental Health Treatment Utilization (measured by the Treatment Services Review [TSR]) | 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. | Baseline, 6-weeks, 3-months, 6-months, 36 months | |
Other | Demographics | 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. | Baseline | |
Other | Borderline personality disorder features (measured by the Personality Assessment Inventory-Borderline Features Scale [PAI-BOR]) | The PAI-BOR is a self-report measure that assesses features of Borderline Personality Disorder. | Baseline, 6-weeks, 3-months, 6-months | |
Other | Alcohol misuse (measured by the Alcohol Use Identification Test [AUDIT]) | The AUDIT is a self-report measure that assesses alcohol intake and potential abuse. | Baseline, 6-weeks, 3-months, 6-months | |
Other | Drug use (measured by the Drug Abuse Screening Test [DAST-10]) | DAST-10 is a screening tool consisting of 10 Yes/No questions that assess drug use problems. | Baseline, 6-weeks, 3-months, 6-months | |
Other | Anxiety (measured by the Generalized Anxiety Disorder 7 [GAD-7]) | The GAD-7 is a 7-item self-report measure that assesses generalized anxiety symptoms. | Baseline, 6-weeks, 3-months, 6-months | |
Other | Coping strategies (measured by the Brief-COPE scale) | The Brief-COPE is a 28-item self-report measure to assess coping strategies. | Baseline, 6-weeks, 3-months, 6-months | |
Other | Virtual Hope Box (VHB) frequency | 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. | Baseline, 6-weeks, 3-months, 6-months | |
Other | VHB app beliefs, usage, and treatment satisfaction | 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. | Baseline | |
Primary | Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] and medical chart review) | 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. | Change from baseline to 6-months | |
Secondary | Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]) | 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. | Baseline, 6-weeks, 3-months, 6-months, 36 months |
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