NCT02365116

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

August 19, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2017

Completed
Last Updated

August 15, 2017

Status Verified

August 1, 2017

Enrollment Period

1.8 years

First QC Date

May 28, 2014

Last Update Submit

August 11, 2017

Conditions

Keywords

Peer MentorshipPsychiatric HospitalizationSuicide Risk

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Current suicidal ideation (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)

    3 and 6 months post-baseline

  • Suicide attempts (measured by the Columbia Suicide Severity Rating Scale)

    3 and 6 months post-baseline

Study Arms (2)

Peer Mentorship intervention

EXPERIMENTAL

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.

Behavioral: Peer mentorship

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care

Interventions

Peer mentorshipBEHAVIORAL

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.

Peer Mentorship intervention

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.

Enhanced Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan Inpatient Psychiatry Unit

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Kingswood Hospital

Ferndale, Michigan, 48220, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry

Study Record Dates

First Submitted

May 28, 2014

First Posted

February 18, 2015

Study Start

August 19, 2015

Primary Completion

May 26, 2017

Study Completion

May 26, 2017

Last Updated

August 15, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations