Organized Self-management Support for Chronic Depression
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Depression |
Procedure: Telephone care management Procedure: peer-led chronic disease self-management workshop Procedure: professionally-led cognitive behavioral psychotherapy group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single Blind |
| Official Title: | Organized Self-management Support for Chronic Depression |
- feasibility and acceptability (including recruitment, intervention uptake and continued participation) of the intervention programs
- clinical outcomes (SCL depression score, depression diagnosis by SCID), functional outcomes (SF-36 Questionnaire, and process variables (self-efficacy for managing depression)
| Estimated Enrollment: | 104 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | June 2005 |
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
-
Contacts and Locations| United States, Washington | |
| Group Health Research Institute | |
| Seattle, Washington, United States, 98101 | |
| Principal Investigator: | Evette J Ludman, PhD | Group Health Cooperative |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00169286 History of Changes |
| Other Study ID Numbers: | R21 MH065530 |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Dysthymic Disorder |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013