Depression Clinical Trial
— StrideOfficial title:
Organized Self-Management Support Services for Chronic Depression
| NCT number | NCT01139060 |
| Other study ID # | 5R01MH082995 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | June 4, 2010 |
| Last updated | October 11, 2017 |
| Start date | August 2009 |
| Verified date | October 2017 |
| Source | Kaiser Permanente |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 302 |
| Est. completion date | |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - all patients will meet criteria for recurrent major depression or dysthymia Exclusion Criteria: - bipolar disorder or psychotic disorder |
| Country | Name | City | State |
|---|---|---|---|
| United States | Group Health Research Insitute | Seattle | Washington |
| United States | Swedish Cherry Hill Clinic | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Kaiser Permanente | Swedish Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Examination of moderators of treatment response | 18 months | ||
| Secondary | An estimate of the program's costs and effect on the costs of treatment for depression | 18 months |
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