- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01566513
Effectiveness and Cost Effectiveness of Peer Mentors in Reducing Hospital Use (Project PEP)
January 22, 2015 updated by: Yale University
The current study, through a randomized controlled design, will evaluate the effectiveness of peer support, as compared to usual care and to an equivalent amount of support offered by peer case managers and non-peer recovery mentors, in reducing hospital days and readmissions and in promoting recovery and community inclusion among adults with mental illnesses with histories of multiple hospitalizations.
The current study evaluates the cost-effectiveness of adding peer support to the array of services available to persons with serious mental illnesses who have histories of multiple hospitalizations and will test a theoretical model of the active ingredients of peer support, focusing specifically on the roles of 1) instillation of hope through positive self-disclosure; 2) role modeling of self-care and exploring new ways of using experiential knowledge; and 3) a trusting relationship characterized by acceptance, understanding, and empathy with conditional regard.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
285
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
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- Yale Psychiatric 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:
- 2 or more psychiatric hospitalizations in the past year
- A diagnosis of serious mental illness
Exclusion Criteria:
- Dementia or other organic condition limiting ability to provide informed consent
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Treatment as usual
|
|
|
Experimental: Community Connector
The participant randomized into this arm of the study is invited to work with a person trained as a community connector, who is trained in Intentional Peer Support but does not have a lived experience of mental illness.
|
The participant randomized into this arm of the study is invited to work with a person trained as a community connector, someone who is trained in Intentional Peer Support but does not have a lived experience of mental illness.
|
|
Experimental: Peer Recovery Mentor
A participant randomized into this arm of the study is offered the chance to work with a Peer Recovery Mentor, who is trained in Intentional Peer Support.
|
A participant randomized into this arm of the study is offered the chance to work with a Peer Recovery Mentor, who is trained in Intentional Peer Support.
|
|
Experimental: Peer Case Manager
If a participant is randomized into this condition, they are offered the chance to work with a Case Manager, who is trained in strengths-based case management.
|
A participant randomized into this arm of the study is offered the chance to work with a Peer Recovery Mentor, who is trained in Intentional Peer Support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Service use
Time Frame: 3 months
|
Via self-report from the participant
|
3 months
|
|
Service Use
Time Frame: 9 months
|
Via self-report from the participant
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychiatric symptoms
Time Frame: 3 months
|
Measured using the Symptom Distress scale and the Paranoia and Psychoticism subscales from the Symptom Check List-90 (SCL-90)
|
3 months
|
|
Quality of life
Time Frame: 3 month
|
Measured using Lehman's Brief Quality of Life scale
|
3 month
|
|
Community inclusion
Time Frame: 3 months
|
Measured using Mancini's Community Connections Inventory
|
3 months
|
|
Psychiatric symptoms
Time Frame: 9 months
|
Measured using the Symptom Distress scale and the Paranoia and Psychoticism subscales from the Symptom Check List-90 (SCL-90)
|
9 months
|
|
Quality of Life
Time Frame: 9 months
|
Measured using Lehman's Brief Quality of Life scale
|
9 months
|
|
Community Inclusion
Time Frame: 9 months
|
Measured using Mancini's Community Connections Inventory
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Larry Davidson, PhD, Yale Program for Recovery and Community Health
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
August 1, 2011
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
March 26, 2012
First Submitted That Met QC Criteria
March 28, 2012
First Posted (Estimate)
March 29, 2012
Study Record Updates
Last Update Posted (Estimate)
January 26, 2015
Last Update Submitted That Met QC Criteria
January 22, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1010007542
- 1R01MH091453 (U.S. NIH Grant/Contract)
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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