- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00522613
Recovery Group Pilot
Study Overview
Status
Intervention / Treatment
Detailed Description
Recent research suggests that many individuals with serious mental illnesses may recover from these conditions and become fully integrated into their communities. Although improved medications may be most responsible for these developments, self-help groups, social support, and empowerment have been identified as important facilitators of the recovery process. Recovery-oriented, consumer-led approaches are gaining in popularity, but few of these interventions have been evaluated scientifically.
This pilot study proposes to develop and evaluate a recovery-oriented program that centers on the use of a self-help workbook. Results from the study will indicate how well the workbook and the overall program were received by individuals with serious mental illness, and whether participating in the program appeared to improve recovery and functioning.
Objectives:
- To develop group-facilitator materials to complement the self-help workbook.
- To conduct a randomized trial of the intervention with kaiser Permanente Northwest (KPNW) members with bipolar disorder or schizophrenia/schizoaffective disorder, using a delayed control group design and 6- and 12-month post-intervention follow-up.
- To assess participant attendance and satisfaction with the group sessions;
- To assess whether participating in the group intervention was associated with improvements in short-term recovery and functioning.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97227
- Kaiser Permanente Center for Health Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of bipolar disorder or schizophrenia/schizoaffective disorder
- current membership in KPNW
- age 18 or over
Exclusion Criteria:
- having a guardian
- psychotic symptoms that interfere with group interactions
- dementia, mental retardation (other than mild) or other organic brain conditions that affect an individual's ability to participate in an interview, a group intervention, or complete questionnaires
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To develop group-facilitator materials to complement the self-help workbook
Time Frame: 6 weeks
|
6 weeks
|
To conduct a randomized trial of the intervention with KPNW members
Time Frame: 6 weeks
|
6 weeks
|
To assess participant attendance and satisfaction with the group sessions
Time Frame: 6 weeks
|
6 weeks
|
To assess whether participating in the group intervention was associated with improvements in short-term recovery and functioning
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carla A. Green, PhD, MPH, Kaiser Permanente
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NW-05CGREE-01
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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