Treatment of Post-TBI Depression - A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Remission of depression (DSM-IV diagnosis no longer met)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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 changes in mood (primarily depression and anxiety), participation in activities and life satisfaction.
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 improved mood, participation, and life satisfaction. Implement exploratory analyses of the relationships between person and injury characteristics and outcomes of treatment. Maximize potential application to clinical practice by: Implementing the treatment in a clinical context so that its utility is demonstrated in a setting that maximizes ecological validity, and Creating and disseminating a manual detailing CBT treatment. This study is a randomized clinical trial that compares two treatment conditions: CBT and supportive psychotherapy (SPT). CBT has been shown to be effective in diverse studies. In this study, CBT has been shaped to be used specifically with people with typical post-TBI cognitive challenges. All participants will be given an opportunity to immediately receive a randomly assigned psychotherapy intervention to potentially enhance coping. Both CBT and SPT will involve 16 sessions of individual treatment. The initial session will be 90 minutes, with remaining sessions 50 minutes. In both treatments, participants will be seen for three months, with sessions twice weekly for the first month and once a week subsequently. The research assistants who will administer pre- and postintervention evaluation instruments will be blind to each participant's randomly assigned treatment condition. Evaluation instruments will be administered at baseline and at three points of follow-up: one week, six months, and one year after treatment. A detailed manual describing treatment methods will be developed based on the intervention.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Remission of depression (DSM-IV diagnosis no longer met)
Time Frame: one year after treatment completion
Secondary Outcomes
- Increased participation (Participation Objective, Participation Subjective)(one year after treatment completion)
- Improved quality of life (Life-3).(one year after treatment completion)