Status:
COMPLETED
Treatment of Post-TBI Depression
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Traumatic Brain Injury
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized clinical trial that compares the effects of cognitive behavioral therapy (CBT) and supportive psychotherapy for depression. Short- and long-term outcomes will be evaluated in terms of chang...
Detailed Description
Goals Demonstrate the efficacy of cognitive behavioral therapy (CBT), both immediately after treatment and in the long term, in alleviating post-TBI depression. Examine the relationship between impro...
Eligibility Criteria
Inclusion
- Being at least 18years old
- Having a TBI as a result of a blow to the head followed by a loss of consciousness or period of being dazed and confused or a period of post traumatic amnesia or clinical signs of altered neurological function; this information must be medically documented (e.g., emergency medical record, hospital record, neuroradiological report, or neurological exam or record of physician's visit within 24 hours of injury)
- Being at least 6 months post injury
- Being English-speaking
- Having residential telephone service
- Living within 1.5 hours of New York City
- Having at least a sixth-grade reading level
- Meeting DSM-IV criteria for a current depressive mood disorder
- Not being in psychotherapy and being willing to abstain from seeking psychotherapy during the course of participation
- Being willing to complete questionnaires and interviews about mood, thinking skills, community participation and life satisfaction
- Agreeing to participate, verified by completion of informed consent and HIPAA documents.
- Individuals who meet criteria and are currently using prescribed mood medications will be included in the study if dosage has been stable for sixty days.
Exclusion
- Pre-existing neurological disorder, including brain injury from an etiology other than trauma
- History of mental retardation
- Lack of capacity to sign informed consent
- Taking antidepressant medications for less than six months
- Having any changes in antidepressant medications in the last six months
- History of current or past psychosis or mania
- Current substance abuse
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00211835
Start Date
November 1 2005
End Date
December 1 2010
Last Update
September 24 2013
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574