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Peer Based Suicide Prevention

Primary Purpose

Suicide

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Specialist Suicide Prevention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Suicide focused on measuring Suicide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CTRecruiting
  • VA Ann Arbor Healthcare System, Ann Arbor, MI
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peer Specialist

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
January 3, 2020
Last Updated
July 6, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04222673
Brief Title
Peer Based Suicide Prevention
Official Title
Evaluating the Use of Peer Specialists to Support Suicide Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicide

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peer Specialist
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Peer Specialist Suicide Prevention
Intervention 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 Outcome Measure Information:
Title
Sheehan Disability Scale (SDS) Change
Description
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.
Time Frame
Baseline, post intervention (3 months post basline), 3 month follow-up
Title
Temple University Community Participation (TUCP) Change
Description
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.
Time Frame
Baseline, post intervention (3 months post basline), 3 month follow-up
Title
Questionnaire about the Process of Recovery (QPR) Change
Description
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.
Time Frame
Baseline, post intervention (3 months post basline), 3 month follow up
Title
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) Change
Description
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.
Time Frame
Baseline, post intervention (3 months post basline), 3 month follow up
Title
Quick Inventory of Depressive Symptoms (QIDS) Change
Description
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.
Time Frame
Baseline, post intervention (3 months post basline), 3 month follow up
Title
Columbia-Suicide Severity Rating Scale (C-SSRS) Change
Description
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.
Time Frame
Baseline, post intervention (3 months post basline), 3 month follow up
Title
Interpersonal Needs Questionnaire (INQ) Change
Description
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.
Time Frame
Baseline, post intervention (3 months post basline), 3 month follow up
Title
Suicide Cognitions Scale (SCS) Change
Description
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
Time Frame
Baseline, post intervention (3 months post basline), 3 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond M Panas, PhD MPH
Phone
(412) 360-2847
Email
Raymond.Panas@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew J Chinman, PhD
Phone
(412) 360-2438
Email
chinman@rand.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J. Chinman, PhD
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Klee, PhD
Phone
203-479-8035
Email
Anne.Klee@va.gov
First Name & Middle Initial & Last Name & Degree
Debbie Deegan
Phone
2034798004
Email
Debbie.Deegan@va.gov
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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