- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02365116
Peer Mentorship to Reduce Suicide Risk Following Psychiatric Hospitalization
Every year in the United States about 1 million people make a suicide attempt and more than 38,000 die by suicide. The risk of suicide is highest among individuals with mental illness who have been hospitalized due to suicidal thoughts or behaviors, yet there are few interventions known to reduce suicide risk in this population. This study will develop and pilot test a peer mentorship intervention by which trained peer professionals will use their own personal experience with recovery from mental illness to instill hope and belongingness in high-risk patients and provide additional support to prevent future suicidal thoughts or behaviors.
The specific aims of the study are to: (1) develop a peer mentorship intervention to reduce suicide risk among patients psychiatrically hospitalized with suicidal ideation or following a suicide attempt; (2) Conduct a randomized controlled pilot study to assess the acceptability, feasibility, and fidelity of the peer mentorship intervention in preparation for a larger efficacy trial; and (3) an exploratory aim will be to measure potential mediators and moderators of intervention effectiveness in terms of belongingness, burdensomeness, and hopelessness according to the interpersonal theory of suicide.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Inpatient Psychiatry Unit
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Ferndale, Michigan, United States, 48220
- Henry Ford Kingswood Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- are age 18 years or older
- have medical record documentation of suicidal ideation or suicide attempt at the time of admission
- are fluent in English
Exclusion Criteria:
- substantially cognitively impaired (according to Mini-Cog)
- unable to provide voluntary, written, informed consent for any reason (including incompetency)
- determined by the patient's attending psychiatrist that due to the patient's psychiatric condition peer mentorship may be harmful to the patient or peer specialist (e.g., severe personality disorder, unstable paranoia)
- already receiving or intending to receive peer mentorship (including having a sponsor from Alcoholics Anonymous) or participate in group-based peer support on a biweekly or more frequent basis
- are receiving electroconvulsive therapy (ECT)
- are located more than 50 miles from any of the peer specialists
- are being discharged to a residential treatment facility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Peer Mentorship intervention
A Peer Specialist will be making weekly follow-up contact with study participants in the community or by telephone for 3 months following hospital discharge.
The content of the peer mentorship interactions will be based on the manual developed by the study team and will include components such as hope and belongingness.
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Patients who are working with a peer specialist will have their sessions audio taped and reviewed by research staff for training purposes and to ensure that peer specialists are following protocol.
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Active Comparator: Enhanced Usual Care
Patients will continue to receive usual care which typically consists of referral to an outpatient psychiatrist.
Participants will also receive a phone call within 24-72 hours from a member of the inpatient unit clinical staff to assess barriers to follow-up care and safety.
The enhancement to usual care will occur at the 3 and 6 month follow-up assessments, where participants will be assessed to determine whether they require any additional referral information for follow-up care.
If referral information is indicated, the patient will be provided a list of mental health treatment providers in their area.
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The enhancement to usual care will occur at the 3 and 6 month follow-up assessments, where participants will be assessed to determine whether they require any additional referral information for follow-up care.
If referral information is indicated, the patient will be provided a list of mental health treatment providers in their area.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention acceptability (median number of peer mentorship contacts at 3 months post-discharge is at least 4, as well as by satisfaction questionnaires.)
Time Frame: 3 and 6 months post-baseline
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Patients' willingness and satisfaction with participating in the intervention as a measure of intervention acceptability.
Measured by at least 70% of participants in both study arms completing follow-up measures at 6 months, the median number of peer mentorship contacts at 3 months post-discharge is at least 4, as well as by satisfaction questionnaires.
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3 and 6 months post-baseline
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Intervention feasibility (Study team's ability to deliver the intervention)
Time Frame: 3 and 6 months post-baseline
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Study team's ability to deliver the intervention as a measure of feasibility.
Measured by at least 50% of eligible patients choosing to enroll in the study, at least 80% of participants assigned to the peer mentorship arm meeting with a peer specialist prior to hospital discharge, at least 70% of participants in both study arms completing follow-up measures at 6 months, and the study meeting its enrollment goal of 60 patients in 12 months.
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3 and 6 months post-baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Current suicidal ideation (measured by the Beck Suicide Scale (BSS)
Time Frame: 3 and 6 months post-baseline
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Patient's current suicidal ideation as measured by the Beck Suicide Scale (BSS)
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3 and 6 months post-baseline
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Peak suicidal ideation (measured by the Columbia Suicide Severity Rating Scale (CSSR-S)
Time Frame: 3 and 6 months post-baseline
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Patient's peak suicidal ideation since the last visit as measured by the Columbia Suicide Severity Rating Scale (CSSR-S)
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3 and 6 months post-baseline
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Suicide attempts (measured by the Columbia Suicide Severity Rating Scale)
Time Frame: 3 and 6 months post-baseline
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Patient's suicide attempts since the last visit as measured by the Columbia Suicide Severity Rating Scale
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3 and 6 months post-baseline
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34MH103447-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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