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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00400166
Other study ID # 0607001641
Secondary ID
Status Completed
Phase N/A
First received November 15, 2006
Last updated June 10, 2009
Start date December 2006
Est. completion date May 2009

Study information

Verified date June 2009
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Recovery Guide support services are effective in promoting recovery and social integration among psychiatrically disabled individuals who experience high rates of inpatient hospitalizations.


Description:

The paradigm shift in mental health treatment from a deficit-and institution- based framework to a recovery and community integration frame necessitates new models of "case management" practices. The Recovery Guide model is just such a model. Beyond theoretical frameworks, the effectiveness of Recovery Guides has not been well studied. It is the intent of this study to conduct a randomized trial examining the effects of Recovery Guides on community tenure and integration. Furthermore, it is the intent of this study to to establish fidelity criteria.

Comparison(s): Recovery Guide services in addition to treatment as usual, compared to treatment as usual.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 18 years of age or older

- Currently admitted in the Yale-New Haven Psychiatric Hospital (YNHPH)

- A history of two or more prior admissions within the past 18 months

- Proficient in the use of the English language

- A DSM-IV diagnosis of Schizophrenia, Schizoaffective Disorder, Psychotic Disorder NOS, or Major Depressive Disorder with Psychotic Features

Exclusion Criteria:

- Inability to give signed, written consent

- Primary DSM-IV diagnosis of substance abuse/dependence

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Behavioral:
Recovery Mentor
Provided Recovery Mentor services

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Yale University Connecticut State, Department of Mental Health and Addiction Services, Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of hospitalizations 9 months No
Secondary Sense of community Baseline, 3 and 9 months No
Secondary Motivation for change Baseline, 3 and 9 months No
Secondary Social functioning Baseline, 3 abd 9 months No
Secondary Hope Baseline, 3 and 9 months No
Secondary Self-determination Baseline, 3 and 9 months No
Secondary Functional status Baseline, 3 and 9 months No
Secondary Treatment relationship Baseline, 3 and 9 months No
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