Back to resultsA Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness
Primary Purpose
Psychotic Disorders, Bipolar Disorders, Suicidal Ideation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SUicide Prevention by Peers Offering Recovery Tactics
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorders
Eligibility Criteria
Inclusion Criteria:
Veteran Inclusion Criteria:
- Veterans who report present suicidal ideation (i.e., Columbia-Suicide Severity Rating Scale (C-SSRS) > 2 ("Active thoughts of killing oneself") in past 1 month and/or a suicide attempt in the prior 3 months as identified by the C-SSRS
- Current SMI diagnosis (i.e., schizophrenia and other psychotic disorders, mood disorders with psychotic features, bipolar disorders)
- Capable of informed consent via the University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
Peer Specialist Inclusion Criteria:
- Certified Peer Specialist employed at VA San Diego Healthcare System (VASDHS) in the Mental Health Care Line (individuals must demonstrate competency in basic suicide screening and referral procedures to be certified)
- 2-3 years of experience post certification as a Certified Peer Specialist
- Interest in being trained in SUPPORT
- Provide verbal or written consent for the research staff to discuss ability to participate in the study with the Peer Specialist's direct clinical supervisor
- Direct clinical supervisor agreement to allow the Peer Specialist to participate. This includes the Peer Specialist's direct clinical supervisor agreement to allow the Peer Specialist time as part of their current scope of practice to 1) participate in the full day (8-hour) SUPPORT training, 2) participate in weekly 1-hour group supervision for the duration of the Peer Specialist's time in the study, and 3) take on a case load of at least one SUPPORT Veteran at a given time.
Exclusion Criteria:
Veteran Exclusion Criteria:
- Cannot complete the assessment battery
- Current intoxication requiring immediate detoxification or outpatient plan directed specifically to residential substance use disorder (not mental health) services
- Imminent psychiatric hospitalization
Sites / Locations
- VA San Diego Healthcare System, San Diego, CARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SUPPORT
ESC
Arm Description
Veterans receiving SUPPORT will be offered all modules of the intervention via weekly, 50-minute sessions with a Peer Specialist. Following the completion of a mental health evaluation by a licensed professional, the Peer Specialist leads the Veteran who is at risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance recall of the Veteran's safety plan and improve recovery.
The enhanced standard care (ESC) condition contains the elements of standard practice suicide prevention delivered at VHA, which include: 1) suicide risk assessment, 2) VA Safety Planning Intervention, 3) timely referral to VA mental health outpatient care, and 4) Suicide Prevention Coordinator follow-up contacts. It is enhanced due to the contact with the research study.
Outcomes
Primary Outcome Measures
Feasibility of recruitment and retention
Recruitment and retention is determined by the number of participants who were initially contacted, consented, completed baseline data, and completed follow-up data.
Acceptability of SUPPORT as measured by the Client Satisfaction Questionniare-8 (CSQ-8)
The CSQ-8 brief survey has been used extensively in VA and non-VA settings to assess overall satisfaction with care, and it has excellent internal consistency (0.93). An overall score" is calculated by summing the participant's rating score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.
Secondary Outcome Measures
Change in the Scale for Suicide Ideation (SSI)
The SSI is an 19-item interviewer administered assessment of suicidal ideation (SI) severity. The total score ranges from 0 to 38 with higher scores indicating more serve SI. The scale has demonstrated strong validity and reliability.
Change in Recovery Assessment Scale-41
The RAS-41 is a self-report measure of personal recovery with five domains: personal confidence and hope; willingness to ask for help; goal and success orientation; reliance on others; no domination by symptoms. A review study found high Cronbach's alphas (.76 and .97) and test-retest reliability (.65 to .88). The RAS has been widely used in VA and non-VA clinical trial studies with diverse populations, a range of mental illnesses, and has demonstrated sensitivity to change over time.
Full Information
NCT ID
NCT05537376
First Posted
September 7, 2022
Last Updated
September 22, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05537376
Brief Title
A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness
Official Title
A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
December 15, 2026 (Anticipated)
Study Completion Date
October 31, 2027 (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
Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.
Detailed Description
This 5-year study aims to refine and pilot a peer-delivered intervention to improve functional and social recovery to decrease suicide risk; the study consists of two phases. Phase 1 employs a user-centered design approach to refine SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT) aided by scientific and consumer advisory board stakeholders as well as training Peer Specialists to fidelity on pilot cases in an open trial. SUPPORT is a flexibly delivered intervention intended to augment safety planning by addressing functional and social goals personalized to each Veteran's recovery following a suicidal crisis while including cognitive learning strategies to enhance recall and salience of intervention material. Following adaptations from Phase 1, Phase 2 includes a pilot randomized controlled trial of SUPPORT compared to an enhanced standard care condition. Veteran participants in both phases will be quantitatively assessed at baseline, mid-treatment, post-treatment, and 3-months post-treatment (and qualitatively interviewed at post-treatment). Peer Specialists delivering the intervention will also be qualitatively interviewed post-treatment. The primary outcomes to be evaluated is improvement in personal recovery and reduction in suicidal ideation severity. Secondary outcomes concern changes in various domains of personal and social functioning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Bipolar Disorders, Suicidal Ideation, Suicide, Attempted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Veterans receiving SUPPORT will be offered all modules of the intervention via weekly, 50-minute sessions with a Peer Specialist. Following the completion of a mental health evaluation by a licensed professional, the Peer Specialist leads the Veteran who is at risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance recall of the Veteran's safety plan and improve recovery.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SUPPORT
Arm Type
Experimental
Arm Description
Veterans receiving SUPPORT will be offered all modules of the intervention via weekly, 50-minute sessions with a Peer Specialist. Following the completion of a mental health evaluation by a licensed professional, the Peer Specialist leads the Veteran who is at risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance recall of the Veteran's safety plan and improve recovery.
Arm Title
ESC
Arm Type
No Intervention
Arm Description
The enhanced standard care (ESC) condition contains the elements of standard practice suicide prevention delivered at VHA, which include: 1) suicide risk assessment, 2) VA Safety Planning Intervention, 3) timely referral to VA mental health outpatient care, and 4) Suicide Prevention Coordinator follow-up contacts. It is enhanced due to the contact with the research study.
Intervention Type
Behavioral
Intervention Name(s)
SUicide Prevention by Peers Offering Recovery Tactics
Other Intervention Name(s)
SUPPORT
Intervention Description
Following the completion of a comprehensive mental health evaluation by a licensed VA provider, which includes a suicide safety plan, if a Veteran is having active thoughts of suicide or made a suicide attempt in past three months, they may be eligible for SUPPORT. In SUPPORT, the Peer Specialist and Veteran co-create a personalized suicide-focused recovery plan (SUPPORT Plan) in flexible, 50-minute weekly encounters. The SUPPORT Plan includes modules that focus on valuing recovery, building a hope kit and daily plan, setting recovery goals, and looking ahead to enhance the Veteran's safety plan. Learning strategies are incorporated into each module to promote salience and recall of intervention material. The Peer Specialist works closely with the Veteran's treatment team and uses the most recent safety plan in the Veteran's chart to help complete the SUPPORT Plan as well as reinforce the usage of the Veteran's safety plan.
Primary Outcome Measure Information:
Title
Feasibility of recruitment and retention
Description
Recruitment and retention is determined by the number of participants who were initially contacted, consented, completed baseline data, and completed follow-up data.
Time Frame
Through study completion, an average of 4 years
Title
Acceptability of SUPPORT as measured by the Client Satisfaction Questionniare-8 (CSQ-8)
Description
The CSQ-8 brief survey has been used extensively in VA and non-VA settings to assess overall satisfaction with care, and it has excellent internal consistency (0.93). An overall score" is calculated by summing the participant's rating score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.
Time Frame
At the end of the intervention, an average of 4-weeks
Secondary Outcome Measure Information:
Title
Change in the Scale for Suicide Ideation (SSI)
Description
The SSI is an 19-item interviewer administered assessment of suicidal ideation (SI) severity. The total score ranges from 0 to 38 with higher scores indicating more serve SI. The scale has demonstrated strong validity and reliability.
Time Frame
Baseline, 2-weeks, 4-weeks, 3-month follow-up
Title
Change in Recovery Assessment Scale-41
Description
The RAS-41 is a self-report measure of personal recovery with five domains: personal confidence and hope; willingness to ask for help; goal and success orientation; reliance on others; no domination by symptoms. A review study found high Cronbach's alphas (.76 and .97) and test-retest reliability (.65 to .88). The RAS has been widely used in VA and non-VA clinical trial studies with diverse populations, a range of mental illnesses, and has demonstrated sensitivity to change over time.
Time Frame
Baseline, 2-weeks, 4-weeks, 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Veteran Inclusion Criteria:
Veterans who report present suicidal ideation (i.e., Columbia-Suicide Severity Rating Scale (C-SSRS) > 2 ("Active thoughts of killing oneself") in past 1 month and/or a suicide attempt in the prior 3 months as identified by the C-SSRS
Current SMI diagnosis (i.e., schizophrenia and other psychotic disorders, mood disorders with psychotic features, bipolar disorders)
Capable of informed consent via the University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
Peer Specialist Inclusion Criteria:
Certified Peer Specialist employed at VA San Diego Healthcare System (VASDHS) in the Mental Health Care Line (individuals must demonstrate competency in basic suicide screening and referral procedures to be certified)
2-3 years of experience post certification as a Certified Peer Specialist
Interest in being trained in SUPPORT
Provide verbal or written consent for the research staff to discuss ability to participate in the study with the Peer Specialist's direct clinical supervisor
Direct clinical supervisor agreement to allow the Peer Specialist to participate. This includes the Peer Specialist's direct clinical supervisor agreement to allow the Peer Specialist time as part of their current scope of practice to 1) participate in the full day (8-hour) SUPPORT training, 2) participate in weekly 1-hour group supervision for the duration of the Peer Specialist's time in the study, and 3) take on a case load of at least one SUPPORT Veteran at a given time.
Exclusion Criteria:
Veteran Exclusion Criteria:
Cannot complete the assessment battery
Current intoxication requiring immediate detoxification or outpatient plan directed specifically to residential substance use disorder (not mental health) services
Imminent psychiatric hospitalization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha A Chalker, PhD
Phone
(619) 680-1735
Email
Samantha.Chalker1@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Colin A Depp, PhD
Phone
(858) 822-4251
Email
Colin.Depp@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha A Chalker, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161-0002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha A Chalker, PhD
Phone
619-680-1735
Email
Samantha.Chalker1@va.gov
First Name & Middle Initial & Last Name & Degree
Samantha A Chalker, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness
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