Peer Based Suicide Prevention
Evaluating the Use of Peer Specialists to Support Suicide Prevention
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Raymond M Panas, PhD MPH
- Phone Number: (412) 360-2847
- Email: Raymond.Panas@va.gov
Study Contact Backup
- Name: Matthew J Chinman, PhD
- Phone Number: (412) 360-2438
- Email: chinman@rand.org
Study Locations
-
-
Connecticut
-
West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15240
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Peer Specialist
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire About the Process of Recovery (QPR) Change
Time Frame: 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.
|
Baseline, post intervention (12 weeks)
|
|
Hearth Hope Index
Time Frame: 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.
|
Baseline, post intervention (12 weeks)
|
|
Suicide Cognitions Scale (SCS) Change
Time Frame: 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
|
Baseline, post intervention (12 weeks)
|
|
Interpersonal Needs Questionnaire (INQ) Change - Perceived Burden
Time Frame: 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.
|
Baseline, post intervention (12 weeks)
|
|
Interpersonal Needs Questionnaire (INQ) Change - Thwarted Belonging
Time Frame: 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.
|
Baseline, post intervention (12 weeks)
|
|
Quick Inventory of Depressive Symptoms (QIDS) Change
Time Frame: 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.
|
Baseline, post intervention (12 weeks)
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation
Time Frame: 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.
|
Baseline, post intervention (12 weeks)
|
|
Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation Intensity
Time Frame: 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.
|
Baseline, post intervention (12 weeks)
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Matthew J. Chinman, PhD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- D3291-P
- RX003291-01A1 (Other Grant/Funding Number: Office of Research & Development)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.