- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00169286
Organized Self-management Support for Chronic Depression
October 11, 2017 updated by: Kaiser Permanente
This study aims to adapt and pilot test two core elements of an organized care program (systematic telephone outreach and monitoring to improve quality and continuity of pharmacotherapy, and structured psychoeducational group programs focused on patient activation and self-management) in a population-based sample of patients with chronic or recurrent depression.
Study Overview
Status
Completed
Conditions
Detailed Description
This study aims to adapt and pilot test two core elements of an organized care program (systematic telephone outreach and monitoring to improve quality and continuity of pharmacotherapy, and structured psychoeducational group programs focused on patient activation and self-management) in a population-based sample of patients with chronic or recurrent depression.
Two forms of group self-management training will be evaluated: a Peer-Led Chronic Disease Self-Management Group (after that developed by Lorig and colleagues) and a Therapist-Led Cognitive-Behavioral Therapy Group.
Approximately 100 patients with chronic or recurrent depression were randomly assigned to one of four conditions: 1) usual care; 2) phone care management; 3) phone care management plus peer-led self-management group; or 4) phone care management plus therapist-led CBT group.
Blinded assessments will examine clinical outcomes (SCL depression score, depression diagnosis by SCID), functional outcomes, and process variables (self-efficacy for managing depression, use of coping strategies) over 12 months.
If patients choose not to participate in treatment, reasons for dropout were assessed.
The data collected will provide:1) an evaluation of the feasibility and acceptability (including recruitment, intervention uptake and continued participation) of the intervention programs; 2) preliminary evaluation of effectiveness, i.e., the effects of each intervention on patient outcomes and process of care; and 3) information to inform the design and implementation of a full-scale effectiveness trial (refinement of intervention programs and measurement strategy, necessary sample size).
Study Type
Interventional
Enrollment
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98101
- Group Health Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- history of at least one major depression in the last two years
- history of recurent major depression or dysthymia
- significant residual symptoms after 6 months of treatment
Exclusion Criteria:
- history of mania or hypomania
- cognitive impairment
- near-terminal medical illness
- intent to disenroll from health plan
emergent clinical needs
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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feasibility and acceptability (including recruitment, intervention uptake and continued participation) of the intervention programs
|
Secondary Outcome Measures
Outcome Measure |
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clinical outcomes (SCL depression score, depression diagnosis by SCID), functional outcomes (SF-36 Questionnaire, and process variables (self-efficacy for managing depression)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Evette J Ludman, PhD, Kaiser Permanente
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Actual)
October 13, 2017
Last Update Submitted That Met QC Criteria
October 11, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21MH065530 (U.S. NIH Grant/Contract)
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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