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Organized Self-management Support for Chronic Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169286
First Posted: September 15, 2005
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kaiser Permanente
  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
Primary Purpose: Other
Official Title: Organized Self-management Support for Chronic Depression

Further study details as provided by Kaiser Permanente:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169286


Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Evette J Ludman, PhD Kaiser Permanente
  More Information

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00169286     History of Changes
Other Study ID Numbers: R21MH065530 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: October 13, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders