Treatment of Post-TBI Depression

Completed · Not applicable

Conditions studied: Traumatic Brain Injury, Depression

In brief

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 changes in mood (primarily depression and anxiety), participation in activities and life satisfaction.

Key facts

Study ID

NCT00211835

Run by

Icahn School of Medicine at Mount Sinai

People needed

75

Starts

2005-11-01

Expected to finish

2010-12-01

Last updated by the study team

2013-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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