NCT01139060

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
302

participants targeted

Target at P50-P75 for phase_3 depression

Geographic Reach
1 country

2 active sites

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

August 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

3.7 years

First QC Date

June 4, 2010

Last Update Submit

October 11, 2017

Conditions

Keywords

chronic or recurrent depression

Outcome Measures

Primary Outcomes (1)

  • 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)

    18 months

Secondary Outcomes (2)

  • 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 Arms (2)

Intervention Group

EXPERIMENTAL

18-month organized treatment program focused on outreach and engagement for chronic or recurrent depression

Behavioral: organized care program for chronic or recurrent depression

Usual Care

NO INTERVENTION

Interventions

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • bipolar disorder or psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Group Health Research Insitute

Seattle, Washington, 98101, United States

Location

Swedish Cherry Hill Clinic

Seattle, Washington, United States

Location

Related Publications (2)

  • Jones SMW, Ludman EJ. Factor Structure and Sensitivity to Change of the Recovery Assessment Scale. J Behav Health Serv Res. 2018 Oct;45(4):690-699. doi: 10.1007/s11414-017-9563-x.

  • Ludman EJ, Simon GE, Grothaus LC, Richards JE, Whiteside U, Stewart C. Organized Self-Management Support Services for Chronic Depressive Symptoms: A Randomized Controlled Trial. Psychiatr Serv. 2016 Jan;67(1):29-36. doi: 10.1176/appi.ps.201400295. Epub 2015 Aug 17.

MeSH Terms

Conditions

DepressionBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Evette Ludman, PhD

    Group Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 8, 2010

Study Start

August 1, 2009

Primary Completion

April 1, 2013

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations