Clinical trial NCT04222673: Peer Based Suicide Prevention
Official title: Evaluating the Use of Peer Specialists to Support Suicide Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Suicide
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-01-10
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Questionnaire About the Process of Recovery (QPR) Change
timeFrame: Baseline, post intervention (12 weeks)
measure: Hearth Hope Index
timeFrame: Baseline, post intervention (12 weeks)
measure: Suicide Cognitions Scale (SCS) Change
timeFrame: Baseline, post intervention (12 weeks)
measure: Interpersonal Needs Questionnaire (INQ) Change - Perceived Burden
timeFrame: Baseline, post intervention (12 weeks)
measure: Interpersonal Needs Questionnaire (INQ) Change - Thwarted Belonging
timeFrame: Baseline, post intervention (12 weeks)
measure: Quick Inventory of Depressive Symptoms (QIDS) Change
timeFrame: Baseline, post intervention (12 weeks)
measure: Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation
timeFrame: Baseline, post intervention (12 weeks)
measure: Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation Intensity
timeFrame: Baseline, post intervention (12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Matthew J. Chinman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmutte T, Krishnamurti LS, Davidson L, Klee A, Bullock J, Panas RM, Pfeiffer PN, Chinman M. Implementing Peer Specialists in Suicide Prevention Efforts in the Veterans Health Administration. Psychiatr Q. 2023 Jun;94(2):311-319. doi: 10.1007/s11126-023-10034-x. Epub 2023 Jun 6.