- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01139060
Organized Self-Management Support Services for Chronic Depression (Stride)
October 11, 2017 updated by: Kaiser Permanente
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
302
Phase
- Phase 3
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
-
-
Washington
-
Seattle, Washington, United States, 98101
- Group Health Research Insitute
-
Seattle, Washington, United States
- Swedish Cherry Hill Clinic
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- all patients will meet criteria for recurrent major depression or dysthymia
Exclusion Criteria:
- bipolar disorder or psychotic disorder
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: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
|
|
Experimental: Intervention Group
18-month organized treatment program focused on outreach and engagement for chronic or recurrent depression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Examination of moderators of treatment response
Time Frame: 18 months
|
18 months
|
An estimate of the program's costs and effect on the costs of treatment for depression
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Evette Ludman, PhD, Group Health Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
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
August 1, 2009
Primary Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
June 4, 2010
First Submitted That Met QC Criteria
June 7, 2010
First Posted (Estimate)
June 8, 2010
Study Record Updates
Last Update Posted (Actual)
October 13, 2017
Last Update Submitted That Met QC Criteria
October 11, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01MH082995 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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