Peer Based Suicide Prevention

Suicide Clinical Trial

Official title:

Evaluating the Use of Peer Specialists to Support Suicide Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04222673
• Other study ID #: D3291-P
• Secondary ID: RX003291-01A1
• Status: Completed
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide Prevention

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sheehan Disability Scale (SDS) Change	The Sheehan Disability Scale (SDS), uses 3 items to measure how much work, social life, and family life are impaired by mental health symptoms. The SDS has been widely used in diverse samples, including Veterans, and found to be psychometrically sound and sensitive to treatment effects. Range=0-30 Higher scores reflect greater perceived disability.	Baseline, post intervention (3 months post basline), 3 month follow-up
Primary	Temple University Community Participation (TUCP) Change	The Temple University Community Participation (TUCP) scale, is a 26-item measure of community inclusion in the past month. The TUCP has been used in previous studies with good reliability. Range=0-26. Higher scores represent greater participation in events in the community.	Baseline, post intervention (3 months post basline), 3 month follow-up
Primary	Questionnaire about the Process of Recovery (QPR) Change	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.	Baseline, post intervention (3 months post basline), 3 month follow up
Primary	Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) Change	The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) consists of 16 items to assess life satisfaction in the past week. The Q-LES-Q-SF has been used extensively with Veterans as part of the National Health and Resilience in Veterans Study (NHRVS). Range=14-70. Higher scores represent better perceived physical health, mood, well-being, and satisfaction with home, social, family, leisure, and living situation.	Baseline, post intervention (3 months post basline), 3 month follow up
Primary	Quick Inventory of Depressive Symptoms (QIDS) Change	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.	Baseline, post intervention (3 months post basline), 3 month follow up
Primary	Columbia-Suicide Severity Rating Scale (C-SSRS) Change	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.	Baseline, post intervention (3 months post basline), 3 month follow up
Primary	Interpersonal Needs Questionnaire (INQ) Change	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.	Baseline, post intervention (3 months post basline), 3 month follow up
Primary	Suicide Cognitions Scale (SCS) Change	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	Baseline, post intervention (3 months post basline), 3 month follow up