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Clinical Trials/NCT01139060
NCT01139060
Completed
Phase 3

Organized Self-Management Support Services for Chronic Depression

Kaiser Permanente2 sites in 1 country302 target enrollmentAugust 2009
ConditionsDepression

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Depression
Sponsor
Kaiser Permanente
Enrollment
302
Locations
2
Primary Endpoint
Evaluate the program's effectiveness, i.e., the effects of the intervention on patient outcomes (depressive symptoms, functional impairment, and disability/lost productivity) and process of care (self-efficacy and self-management behaviors)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose is to test the effectiveness of an organized care program for chronic or recurrent depression. Using a two-arm design, the investigators will randomly assign 300 participants with chronic or recurrent depression to one of two conditions: continued usual care (UC); or an 18-month organized treatment program focused on outreach and engagement, including a weekly group self-management training program, monthly visits with a psychotherapist (in-person or by telephone), and optional one-on-one visits with a peer support specialist. All intervention components are intended as adjuncts to any existing depression treatment (usually antidepressant medication) provided by participants' regular providers.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
April 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • all patients will meet criteria for recurrent major depression or dysthymia

Exclusion Criteria

  • bipolar disorder or psychotic disorder

Outcomes

Primary Outcomes

Evaluate the program's effectiveness, i.e., the effects of the intervention on patient outcomes (depressive symptoms, functional impairment, and disability/lost productivity) and process of care (self-efficacy and self-management behaviors)

Time Frame: 18 months

Secondary Outcomes

  • Examination of moderators of treatment response(18 months)
  • An estimate of the program's costs and effect on the costs of treatment for depression(18 months)

Study Sites (2)

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