Telephone care management and peer-led chronic disease self-management workshop and professionally-led cognitive behavioral psychotherapy group in Depression - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Depression

Intervention / Treatment

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).

Study Type

Interventional

Enrollment

104

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Washington
  - Seattle, Washington, United States, 98101
    - Group Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Other
Allocation: Randomized
Interventional Model: Factorial Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
feasibility and acceptability (including recruitment, intervention uptake and continued participation) of the intervention programs

Secondary Outcome Measures

Outcome Measure
clinical outcomes (SCL depression score, depression diagnosis by SCID), functional outcomes (SF-36 Questionnaire, and process variables (self-efficacy for managing depression)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

Principal Investigator: Evette J Ludman, PhD, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria