Status:
COMPLETED
Life Improvement Following Traumatic Brain Injury
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Traumatic Brain Injury
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to test the effectiveness of a telephone-based and in-person Cognitive Behavioral Therapy (CBT) intervention for treating Major Depressive Disorder (MDD) following Traumat...
Detailed Description
Major Depressive Disorder (MDD) is the most prevalent psychiatric disorder in persons with traumatic brain injury (TBI) and is most common during the first several years after injury. MDD following TB...
Eligibility Criteria
Inclusion
- hospitalized for TBI within the last 10 years, and at least one month post-injury
- sustained a complicated mild to severe TBI as indicated by Glasgow Coma Scale score of 3-12 or had documented intracranial abnormalities on CT scan or had post-traumatic amnesia (PTA) of at least 7 days
- meet screening criteria for major depression
- speak English fluently
- resides in any of the the 50 United States
Exclusion
- does not have a telephone
- does not have a stable address
- history of bipolar disorder or schizophrenia, or current psychosis or suicidal intent
- current alcohol or substance dependence (within last month)
- evidence of significant cognitive impairment on neuropsychological testing
- started on an antidepressant medication within 6 weeks or planning to start on an antidepressant within the 16-week study
- currently in psychotherapy for depression or plan to start psychotherapy for depression within the 16-week study period
- refusal to participate
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00878150
Start Date
September 1 2007
End Date
September 1 2013
Last Update
October 18 2013
Active Locations (1)
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1
University of Washington School of Medicine
Seattle, Washington, United States, 98195