Organized Self-management Support for Chronic Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone care management
peer-led chronic disease self-management workshop
professionally-led cognitive behavioral psychotherapy group
Sponsored by
About this trial
This is an interventional other trial for Depression
Eligibility Criteria
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 -
Sites / Locations
- Group Health Research Institute
Outcomes
Primary Outcome Measures
feasibility and acceptability (including recruitment, intervention uptake and continued participation) of the intervention programs
Secondary Outcome Measures
clinical outcomes (SCL depression score, depression diagnosis by SCID), functional outcomes (SF-36 Questionnaire, and process variables (self-efficacy for managing depression)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00169286
Brief Title
Organized Self-management Support for Chronic Depression
Official Title
Organized Self-management Support for Chronic Depression
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
4. Oversight
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
104 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Telephone care management
Intervention Type
Procedure
Intervention Name(s)
peer-led chronic disease self-management workshop
Intervention Type
Procedure
Intervention Name(s)
professionally-led cognitive behavioral psychotherapy group
Primary Outcome Measure Information:
Title
feasibility and acceptability (including recruitment, intervention uptake and continued participation) of the intervention programs
Secondary Outcome Measure Information:
Title
clinical outcomes (SCL depression score, depression diagnosis by SCID), functional outcomes (SF-36 Questionnaire, and process variables (self-efficacy for managing depression)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evette J Ludman, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Organized Self-management Support for Chronic Depression
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