Clinical trial NCT00169286: Organized Self-management Support for Chronic Depression
Official title: Organized Self-management Support for Chronic Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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).

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

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Primary outcomes:
measure: feasibility and acceptability (including recruitment, intervention uptake and continued participation) of the intervention programs
Secondary outcomes:
measure: clinical outcomes (SCL depression score, depression diagnosis by SCID), functional outcomes (SF-36 Questionnaire, and process variables (self-efficacy for managing depression)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Evette J Ludman, PhD
role: PRINCIPAL_INVESTIGATOR
References: