Depression Clinical Trial
Official title:
Integrated Telemental Health Intervention for Depression in Primary Care
Verified date | January 2013 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
This study will develop and evaluate the effectiveness of a technology-assisted behavioral intervention, consisting of Internet-based cognitive behavioral therapy combined with telephone and email support, in reducing depressive symptoms and improving treatment adherence in primary care patients with major depressive disorder.
Status | Completed |
Enrollment | 102 |
Est. completion date | July 2012 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of MDD as assessed using the Mini Mental State Exam (MINI) - Has a telephone, email account, computer, and broadband access to the Internet - Able to navigate the Internet - Able to speak and read English Exclusion Criteria: - Hearing or voice impairment - Visual impairment that would prevent use of the workbook and completion of assessment materials - Meets criteria for dementia - Diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous - Currently receiving individual psychotherapy or planning to receive psychotherapy during the 12-week treatment phase of the study - Planning to be out of town or unavailable for treatment for 4 weeks or more during the scheduled treatment time - Exhibits severe suicidality, including ideation, plan, and intent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depression | PhQ-9 and diagnosis (using MINI) | Measured at baseline and Weeks 6 & 12 (post treatment) | No |
Primary | Utilization and Attrition | # logins | Baseline-Week 12 | No |
Secondary | Patient Satisfaction (Satisfaction Index-Mental Health) | Measured at baseline and Weeks 6 & 12 | No |
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