Suicidal IdeationNCT02365116
Peer Mentorship to Reduce Suicide Risk Following Psychiatric Hospitalization
A study testing Peer mentorship in people with Suicidal Ideation, run by University of Michigan at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Peer mentorship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Aug 2015to 26 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Inpatient Psychiatry Unit
Ann Arbor, Michigan, 48109
Henry Ford Kingswood Hospital
Ferndale, Michigan, 48220
About this study
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.
- Conditions
- Suicidal Ideation
- Being tested
- Peer mentorship, Enhanced Usual Care
- Keywords
- Peer Mentorship, Psychiatric Hospitalization, Suicide Risk
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer mentorshipBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 and 6 months post-baseline
Secondary outcomes (3)
Current suicidal ideation (measured by the Beck Suicide Scale (BSS)
Patient's current suicidal ideation as measured by the Beck Suicide Scale (BSS)
Measured: 3 and 6 months post-baseline
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)
Measured: 3 and 6 months post-baseline
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
Measured: 3 and 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study start19 Aug 2015
- Primary completion26 May 2017
- Study completion26 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Paul Pfeiffer, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365116
- Sponsor's protocol ID
- R34MH103447-01
- Status last verified
- Aug 2017
- First submitted
- 28 May 2014
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Mentorship to Reduce Suicide Risk Following Psychiatric Hospitalization
- ClinicalTrials.gov ID
- NCT02365116
- Acronym / sponsor ID
- R34MH103447-01
- Conditions
- Suicidal Ideation
- Keywords
- Peer Mentorship, Psychiatric Hospitalization, Suicide Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 19 Aug 2015 (actual)
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Mentorship intervention | Experimental | Behavioral: Peer mentorshipA 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. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CarePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer mentorshipPatients 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. | Behavioural | Peer Mentorship intervention |
| Enhanced Usual CareThe 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. | Behavioural | Enhanced Usual Care |
Primary outcome
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.
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 secondary outcomes
Current suicidal ideation (measured by the Beck Suicide Scale (BSS)
Time frame: 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
Suicide attempts (measured by the Columbia Suicide Severity Rating Scale)
Time frame: 3 and 6 months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer mentorship in people with Suicidal Ideation, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.