Organized Self-management Support for Chronic Depression

This study has been completed.
Sponsor:
Information provided by:
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00169286
First received: September 12, 2005
Last updated: March 31, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

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)

Estimated Enrollment: 104
Study Start Date: July 2003
Estimated Study Completion Date: June 2005
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169286

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Investigators
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: March 31, 2014
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 July 22, 2014