Stride: Organized Self-Management Support Services for Chronic Depression

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT01139060
• Collaborator: Swedish Medical Center (Other)
• Enrollment: 302
• Locations: 2
• Arms: 2
• Patients Per Site: 151

Study Details

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 302 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Organized Self-Management Support Services for Chronic Depression
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Examination of moderators of treatment response [18 months]

2. An estimate of the program's costs and effect on the costs of treatment for depression [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• bipolar disorder or psychotic disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Group Health Research Insitute	Seattle	Washington	United States	98101
2	Swedish Cherry Hill Clinic	Seattle	Washington	United States

Sponsors and Collaborators

• Kaiser Permanente
• Swedish Medical Center

Investigators

• Principal Investigator: Evette Ludman, PhD, Group Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT01139060
• Other Study ID Numbers: 5R01MH082995
• First Posted: Jun 8, 2010
• Last Update Posted: Oct 13, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Kaiser Permanente: chronic or recurrent depression
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Oct 13, 2017