Recovery Group Pilot

Schizophrenia Clinical Trial

Official title:

Recovery Group Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522613
• Other study ID #: NW-05CGREE-01
• Status: Completed
• Phase: N/A
• First received: August 29, 2007
• Last updated: February 3, 2009
• Start date: July 2005
• Est. completion date: December 2006

Study information

• Verified date: September 2006
• Source: Kaiser Permanente
• 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 develop and evaluate a low-cost, joint consumer/counselor-led, health education and support intervention that will foster self-care and recovery among adults with serious mental illness. 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.

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:

1. To develop group-facilitator materials to complement the self-help workbook.

2. 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.

3. To assess participant attendance and satisfaction with the group sessions;

4. To assess whether participating in the group intervention was associated with improvements in short-term recovery and functioning.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Recovery Group Project
Recovery Group Workbook & Group Sessions

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	Portland State University, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop group-facilitator materials to complement the self-help workbook		6 weeks	No
Primary	To conduct a randomized trial of the intervention with KPNW members		6 weeks	No
Primary	To assess participant attendance and satisfaction with the group sessions		6 weeks	No
Primary	To assess whether participating in the group intervention was associated with improvements in short-term recovery and functioning		6 weeks	No