NCT00169286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

First QC Date

September 12, 2005

Last Update Submit

October 11, 2017

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Telephone care managementPROCEDURE
peer-led chronic disease self-management workshopPROCEDURE
professionally-led cognitive behavioral psychotherapy groupPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • history of mania or hypomania
  • cognitive impairment
  • near-terminal medical illness
  • intent to disenroll from health plan
  • emergent clinical needs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Evette J Ludman, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

July 1, 2003

Study Completion

June 1, 2005

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)