Organized Self-management Support for Chronic Depression

Depression Clinical Trial

Official title:

Organized Self-management Support for Chronic Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169286
• Other study ID #: R21MH065530
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: October 11, 2017
• Start date: July 2003
• Est. completion date: June 2005

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Procedure:
• Telephone care management

• peer-led chronic disease self-management workshop

• professionally-led cognitive behavioral psychotherapy group

Locations

Country	Name	City	State
United States	Group Health Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility and acceptability (including recruitment, intervention uptake and continued participation) of the intervention programs
Secondary	clinical outcomes (SCL depression score, depression diagnosis by SCID), functional outcomes (SF-36 Questionnaire, and process variables (self-efficacy for managing depression)