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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02365116
Other study ID # R34MH103447-01
Secondary ID
Status Completed
Phase N/A
First received May 28, 2014
Last updated August 11, 2017
Start date August 19, 2015
Est. completion date May 26, 2017

Study information

Verified date August 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date May 26, 2017
Est. primary completion date May 26, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Peer mentorship
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.
Enhanced Usual Care
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.

Locations

Country Name City State
United States University of Michigan Inpatient Psychiatry Unit Ann Arbor Michigan
United States Henry Ford Kingswood Hospital Ferndale Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intervention acceptability (median number of peer mentorship contacts at 3 months post-discharge is at least 4, as well as by satisfaction questionnaires.) 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
Primary Intervention feasibility (Study team's ability to deliver the intervention) 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 Current suicidal ideation (measured by the Beck Suicide Scale (BSS) Patient's current suicidal ideation as measured by the Beck Suicide Scale (BSS) 3 and 6 months post-baseline
Secondary Peak suicidal ideation (measured by the Columbia Suicide Severity Rating Scale (CSSR-S) 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
Secondary Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) Patient's suicide attempts since the last visit as measured by the Columbia Suicide Severity Rating Scale 3 and 6 months post-baseline
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