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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01566513
Other study ID # 1010007542
Secondary ID 1R01MH091453
Status Completed
Phase N/A
First received March 26, 2012
Last updated January 22, 2015
Start date August 2011
Est. completion date November 2013

Study information

Verified date January 2015
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 285
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Community Connector
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.
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.
Peer Case Manager
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.

Locations

Country Name City State
United States Yale Psychiatric Hospital New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Service use Via self-report from the participant 3 months No
Primary Service Use Via self-report from the participant 9 months No
Secondary Psychiatric symptoms Measured using the Symptom Distress scale and the Paranoia and Psychoticism subscales from the Symptom Check List-90 (SCL-90) 3 months No
Secondary Quality of life Measured using Lehman's Brief Quality of Life scale 3 month No
Secondary Community inclusion Measured using Mancini's Community Connections Inventory 3 months No
Secondary Psychiatric symptoms Measured using the Symptom Distress scale and the Paranoia and Psychoticism subscales from the Symptom Check List-90 (SCL-90) 9 months No
Secondary Quality of Life Measured using Lehman's Brief Quality of Life scale 9 months No
Secondary Community Inclusion Measured using Mancini's Community Connections Inventory 9 months No
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