Trial Outcomes & Findings for Peer Based Suicide Prevention (NCT NCT04222673)
NCT ID: NCT04222673
Last Updated: 2025-11-05
Results Overview
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.
COMPLETED
NA
17 participants
Baseline, post intervention (12 weeks)
2025-11-05
Participant Flow
Given the nature of the subject matter (suicide), recruitment for the study was extremely challenging. Therefore, instead of having a pre-pilot and then a formal pilot, we collected data all at once in one pilot. That is why we are reporting the data all together in one group. Also, the 'needs assessment' process was simply informal qualitative discussions with various stakeholders that helped us adapt the programs to the VA. That is why the information is not reported here.
Participant milestones
| Measure |
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.
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.
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|---|---|
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Overall Study
STARTED
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17
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
| Measure |
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.
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.
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|---|---|
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Overall Study
Lost to Follow-up
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5
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Baseline Characteristics
Peer Based Suicide Prevention
Baseline characteristics by cohort
| Measure |
Peer Specialist
n=12 Participants
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.
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.
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|---|---|
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Age, Continuous
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51.2 years
STANDARD_DEVIATION 17.7 • n=15 Participants
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Sex: Female, Male
Female
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1 Participants
n=15 Participants
|
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Sex: Female, Male
Male
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11 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=15 Participants
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|
Race (NIH/OMB)
Black or African American
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6 Participants
n=15 Participants
|
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Race (NIH/OMB)
White
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6 Participants
n=15 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=15 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=15 Participants
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Region of Enrollment
United States
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12 Participants
n=15 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Peer Specialist
n=12 Participants
3 month PREVAIL intervention
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|---|---|
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Questionnaire About the Process of Recovery (QPR) Change
Baseline
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48.3 score on a scale
Standard Deviation 10.9
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Questionnaire About the Process of Recovery (QPR) Change
Post
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50.1 score on a scale
Standard Deviation 11.9
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Peer Specialist
n=12 Participants
3 month PREVAIL intervention
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|---|---|
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Hearth Hope Index
Baseline
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27.5 score on a scale
Standard Deviation 6.84
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Hearth Hope Index
Post
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29.2 score on a scale
Standard Deviation 7.93
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PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Peer Specialist
n=12 Participants
3 month PREVAIL intervention
|
|---|---|
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Suicide Cognitions Scale (SCS) Change
Baseline
|
38.8 score on a scale
Standard Deviation 7.78
|
|
Suicide Cognitions Scale (SCS) Change
Post
|
36.3 score on a scale
Standard Deviation 11.2
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Peer Specialist
n=12 Participants
3 month PREVAIL intervention
|
|---|---|
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Interpersonal Needs Questionnaire (INQ) Change - Perceived Burden
Baseline
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20.7 score on a scale
Standard Deviation 9.56
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Interpersonal Needs Questionnaire (INQ) Change - Perceived Burden
Post
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20.3 score on a scale
Standard Deviation 11.7
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Peer Specialist
n=12 Participants
3 month PREVAIL intervention
|
|---|---|
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Interpersonal Needs Questionnaire (INQ) Change - Thwarted Belonging
Baseline
|
37.3 score on a scale
Standard Deviation 7.02
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Interpersonal Needs Questionnaire (INQ) Change - Thwarted Belonging
Post
|
41.1 score on a scale
Standard Deviation 8.86
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Peer Specialist
n=12 Participants
3 month PREVAIL intervention
|
|---|---|
|
Quick Inventory of Depressive Symptoms (QIDS) Change
Baseline
|
19.4 score on a scale
Standard Deviation 8.51
|
|
Quick Inventory of Depressive Symptoms (QIDS) Change
Post
|
17.3 score on a scale
Standard Deviation 8.34
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Peer Specialist
n=12 Participants
3 month PREVAIL intervention
|
|---|---|
|
Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation
Baseline
|
2.67 score on a scale
Standard Deviation 1.78
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Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation
Post
|
1.08 score on a scale
Standard Deviation .99
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Peer Specialist
n=12 Participants
3 month PREVAIL intervention
|
|---|---|
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Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation Intensity
Baseline
|
11.8 score on a scale
Standard Deviation 4.99
|
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Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation Intensity
Post
|
9.42 score on a scale
Standard Deviation 7.69
|
Adverse Events
Peer Specialist
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place