Peer Based Suicide Prevention

Not Applicable

Completed

Conditions: Suicide

Interventions: Behavioral: Peer Specialist Suicide Prevention

Registration Number: NCT04222673

Lead Sponsor: VA Office of Research and Development

Brief Summary: Veterans Health Administration (VHA) suicide rates remain high, requiring new approaches. VHA patients tend to have high medical and behavioral health care needs that cause disruption in their lives and heighten their risk of suicide. This study will adapt and pilot test an intervention that expands the focus of care for VHA patients with high risk for suicide to building a life of self-respect, meaning, and connectedness in one's local community. The pilot intervention will involve receiving support and mentorship from a fellow Veteran living with the same challenges who has been trained in helping others manage their disabilities while achieving specific life goals (i.e., a 'Peer Specialist'). Results from this study will demonstrate the preliminary effectiveness of supplementing the VHA's current clinical approaches to suicide prevention with support provided by a trained Peer Specialist that offers empathy, hope, and practical advice that stemming from 'lived experience' of disability and recovery.

Detailed Description: The investigators have assembled a team of clinical psychologists and researchers to use Intervention Mapping (IM) to adapt and test PREVAIL (a non VA, peer specialist based suicide prevention program) as a Peer Specialist (PS)-delivered intervention to reduce suicide ideation in VA patients who are at high risk of suicide. Building on the investigators' work with PSs, suicide research, and participatory methods, the investigators will begin the IM process with a needs assessment that includes interviews with PSs, VHA patients, providers, and directors (n=12) to assess attitudes and perceptions of current clinical practices for high risk Veterans, PSs, and areas of possible improvement in suicide prevention. This information will be shared with a steering committee to begin adapting PREVAIL to patients with high suicide risk in VHA. Following best practices for pilot investigations and intervention adaptation, the investigators will recruit 12 VHA patients with unipolar or bipolar depression flagged for high suicide risk to participate in a "pre-pilot" and provide feedback on how the adapted intervention may be revised. After making any necessary modifications to the intervention, the investigators will recruit a second group of 12 high risk Veterans for a "formal pilot" to further evaluate the feasibility and acceptability of recruitment, retention, and assessment procedures for a large randomized trial. Outcome variables will include health care visits for suicide-related reasons and self-reported suicidal ideation/acts as well as several outcomes that are rehabilitative in nature, such as self-rated community integration; sense of hope, meaning, and purpose; and self-esteem and social support. The investigators aim to: Aim 1: Use Intervention Mapping to identify which components of PREVAIL require adaptation to reduce suicidal ideation in high risk VHA patients and to identify implementation strategies in the VHA system; Aim 2: Pilot test the feasibility and acceptability of the adapted PREVAIL, rehabilitative measures, and suicide-related outcomes for use in a rigorous prospective study.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 17

Inclusion Criteria

The investigators will target Veterans with suicide flags because they are at greatest risk for suicide and therefore most in need of intervention
Eligibility will be limited to Veterans diagnosed with unipolar or bipolar depression as this diagnostic group is the most prevalent in suicidal samples and is supported by prior meta-analyses on peer-provided interventions
The investigators will ensure decision-making capacity using the Blessed Orientation, Memory, Concentration Test and a brief quiz about the study
This quiz will involve an iterative process of querying the participants' understanding of consent information with a 10-item true/false test and providing feedback until an acceptable level of understanding is achieved (must get 100% correct after 3 tries to enroll)

Exclusion Criteria

cognitive impairment as indicated by a Blessed score of >10
unable to provide voluntary, written informed consent for any reason
- e.g., incompetency
determination by the patient's psychiatrist not to be appropriate for participation due to unstable psychosis, cognitive disorder, or severe personality disorder
residing more than 50 miles away

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peer Specialist	Peer Specialist Suicide Prevention	The intervention will last 3-months, a time frame that overlaps with the typical duration of a VA suicide high risk flag. Meetings will be 30-45 minutes and occur primarily in the community, home, or by telephone. Session content will be rooted in Peer Specialists (PSs) offering nonjudgmental empathic support, active listening, and constructive disclosure and role modeling. A primary focus will be helping patients with flags to identify and strengthen connections with informal supports and participation in activities in their community that will enable them to feel more worthwhile as individuals and hopeful about their future.

Primary Outcome Measures

Name	Time	Method
Questionnaire About the Process of Recovery (QPR) Change	Baseline, post intervention (12 weeks)	The Questionnaire about the Process of Recovery (QPR), contains 15 items that measure connectedness, hope, identity, meaning, and empowerment. The QPR has demonstrated high internal and convergent validity as well as sensitivity to change. Range=0-60. High scores reflect greater connectedness, hope, positive identify, meaning, and empowerment.
Hearth Hope Index	Baseline, post intervention (12 weeks)	a 12-item index shown to be reliable (a=.97) and valid, correlating with the Existential Well-Being Scale (r=.84) and the Hopelessness Scale (r=-.73). Scoring consists of summing the points for each item (ranges from 1 - least amount of hope to 4, indicating the most amount of hope) to make a total scale. Total possible points on the total scale is 48 points; the lowest is 12. The higher the score the higher the level of hope.
Suicide Cognitions Scale (SCS) Change	Baseline, post intervention (12 weeks)	The Suicide Cognitions Scale (SCS), contains18 items that assess thoughts of unlovability, unsolvability, and unbearability. The SCS has strong psychometric qualities in diverse samples (including Veterans) with incremental validity to predicting suicidal behavior beyond depression, INQ scores, prior attempts, and suicidal ideation. Range 18-90. Higher scores reflected greater sense of unlovability and inability to cope
Interpersonal Needs Questionnaire (INQ) Change - Perceived Burden	Baseline, post intervention (12 weeks)	The Interpersonal Needs Questionnaire (INQ) uses 15 items to measure two underlying motives for suicidal desire (i.e., perceived burden and thwarted belonging). The INQ has established validity and reliability, including with on Veterans. Range 15-105. Higher scores associated with greater sense of perceived burden and thwarted belongingness.
Interpersonal Needs Questionnaire (INQ) Change - Thwarted Belonging	Baseline, post intervention (12 weeks)	The Interpersonal Needs Questionnaire (INQ) uses 15 items to measure two underlying motives for suicidal desire (i.e., perceived burden and thwarted belonging). The INQ has established validity and reliability, including with on Veterans. Range 15-105. Higher scores associated with greater sense of perceived burden and thwarted belongingness.
Quick Inventory of Depressive Symptoms (QIDS) Change	Baseline, post intervention (12 weeks)	To assess depression symptoms, the investigators will use the Quick Inventory of Depressive Symptoms (QIDS) which consists of 16 questions to assess depression severity. The QIDS has demonstrated high reliability, validity, and sensitivity to treatment change, including among Veterans. Range=0-27. Higher scores represent increasing severity of depression.
Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation	Baseline, post intervention (12 weeks)	Suicide measures will include the Columbia-Suicide Severity Rating Scale (C-SSRS) to assess suicidal ideation (past 30 days) and behaviors (past 3 months). Suicide ideation items include: (1) wish to be dead, (2) nonspecific active suicidal thoughts, (3) suicidal thoughts with methods, (4) suicidal intent, and (5) suicidal intent with plan. The suicidal behavior subscales include: (1) attempts (actual, aborted interrupted), (2) preparatory behavior, and (3) non-suicidal self-injurious behavior. Range= 0-10. Higher scores represent increasing presence of suicide-related behaviors and thoughts.
Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation Intensity	Baseline, post intervention (12 weeks)	Suicide measures will include the Columbia-Suicide Severity Rating Scale (C-SSRS) to assess suicidal ideation (past 30 days) and behaviors (past 3 months). Suicide ideation items include: (1) wish to be dead, (2) nonspecific active suicidal thoughts, (3) suicidal thoughts with methods, (4) suicidal intent, and (5) suicidal intent with plan. The suicidal behavior subscales include: (1) attempts (actual, aborted interrupted), (2) preparatory behavior, and (3) non-suicidal self-injurious behavior. Range= 0-25. Higher scores represent increasing presence of suicide-related behaviors and thoughts.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): VA Ann Arbor Healthcare System, Ann Arbor, MI
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Ann Arbor, Michigan, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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West Haven, Connecticut, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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Pittsburgh, Pennsylvania, United States