Organized Self-Management Support Services for Chronic Depression (Stride)

This study has been completed.
Sponsor:
Collaborator:
Swedish Medical Center
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT01139060
First received: June 4, 2010
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Depression
Behavioral: organized care program for chronic or recurrent depression
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Organized Self-Management Support Services for Chronic Depression

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Examination of moderators of treatment response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • An estimate of the program's costs and effect on the costs of treatment for depression [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 302
Study Start Date: August 2009
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
18-month organized treatment program focused on outreach and engagement for chronic or recurrent depression
Behavioral: organized care program for chronic or recurrent depression
No Intervention: Usual Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • bipolar disorder or psychotic disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139060

Locations
United States, Washington
Group Health Research Insitute
Seattle, Washington, United States, 98101
Swedish Cherry Hill Clinic
Seattle, Washington, United States
Sponsors and Collaborators
Group Health Cooperative
Swedish Medical Center
Investigators
Principal Investigator: Evette Ludman, PhD Group Health Research Institute
  More Information

No publications provided

Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT01139060     History of Changes
Other Study ID Numbers: 5R01MH082995
Study First Received: June 4, 2010
Last Updated: August 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
chronic or recurrent depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Dysthymic Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014