Peer Mentorship to Reduce Suicide Risk Following Psychiatric Hospitalization

August 11, 2017 updated by: Paul Pfeiffer, University of Michigan

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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Inpatient Psychiatry Unit
      • Ferndale, Michigan, United States, 48220
        • Henry Ford Kingswood Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. are age 18 years or older
  2. have medical record documentation of suicidal ideation or suicide attempt at the time of admission
  3. are fluent in English

Exclusion Criteria:

  1. substantially cognitively impaired (according to Mini-Cog)
  2. unable to provide voluntary, written, informed consent for any reason (including incompetency)
  3. 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)
  4. 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
  5. are receiving electroconvulsive therapy (ECT)
  6. are located more than 50 miles from any of the peer specialists
  7. are being discharged to a residential treatment facility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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.
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.
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.

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
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.
3 and 6 months post-baseline
Intervention feasibility (Study team's ability to deliver the intervention)
Time Frame: 3 and 6 months post-baseline
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.
3 and 6 months post-baseline

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
Patient's current suicidal ideation as measured by the Beck Suicide Scale (BSS)
3 and 6 months post-baseline
Peak suicidal ideation (measured by the Columbia Suicide Severity Rating Scale (CSSR-S)
Time Frame: 3 and 6 months post-baseline
Patient's peak suicidal ideation since the last visit as measured by the Columbia Suicide Severity Rating Scale (CSSR-S)
3 and 6 months post-baseline
Suicide attempts (measured by the Columbia Suicide Severity Rating Scale)
Time Frame: 3 and 6 months post-baseline
Patient's suicide attempts since the last visit as measured by the Columbia Suicide Severity Rating Scale
3 and 6 months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2015

Primary Completion (Actual)

May 26, 2017

Study Completion (Actual)

May 26, 2017

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • R34MH103447-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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