NCT00522613

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
Last Updated

February 4, 2009

Status Verified

September 1, 2006

Enrollment Period

1.4 years

First QC Date

August 29, 2007

Last Update Submit

February 3, 2009

Conditions

Keywords

recoveryserious mental illnessbipolar disorderschizophreniaschizoaffective disorder

Outcome Measures

Primary Outcomes (4)

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

    6 weeks

  • To conduct a randomized trial of the intervention with KPNW members

    6 weeks

  • To assess participant attendance and satisfaction with the group sessions

    6 weeks

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

    6 weeks

Interventions

Recovery Group Workbook \& Group Sessions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of bipolar disorder or schizophrenia/schizoaffective disorder
  • current membership in KPNW
  • age 18 or over

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Bipolar DisorderSchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Carla A. Green, PhD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 30, 2007

Study Start

July 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

February 4, 2009

Record last verified: 2006-09

Locations