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

Primary Purpose

Depression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
organized care program for chronic or recurrent depression
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring chronic or recurrent depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • bipolar disorder or psychotic disorder

Sites / Locations

  • Group Health Research Insitute
  • Swedish Cherry Hill Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Usual Care

Arm Description

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

Outcomes

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)

Secondary Outcome Measures

Examination of moderators of treatment response
An estimate of the program's costs and effect on the costs of treatment for depression

Full Information

First Posted
June 4, 2010
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
Swedish Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01139060
Brief Title
Organized Self-Management Support Services for Chronic Depression
Acronym
Stride
Official Title
Organized Self-Management Support Services for Chronic Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Swedish Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
chronic or recurrent depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
18-month organized treatment program focused on outreach and engagement for chronic or recurrent depression
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
organized care program for chronic or recurrent depression
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Examination of moderators of treatment response
Time Frame
18 months
Title
An estimate of the program's costs and effect on the costs of treatment for depression
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all patients will meet criteria for recurrent major depression or dysthymia Exclusion Criteria: bipolar disorder or psychotic disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evette Ludman, PhD
Organizational Affiliation
Group Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Research Insitute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Cherry Hill Clinic
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28726086
Citation
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.
Results Reference
derived
PubMed Identifier
26278222
Citation
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.
Results Reference
derived

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Organized Self-Management Support Services for Chronic Depression

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