Clinical Trial: TREATMENT OF POST-TBI DEPRESSION

This study is not yet open for patient recruitment.
Verified by Mount Sinai School of Medicine October 2005

Sponsors and Collaborators: Mount Sinai School of Medicine
National Institute of Disability and Rehabilitation Research
Information provided by: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00233116

Purpose

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.
Condition Intervention
Depression
 Behavior: Cognitive Behavioral Therapy

MedlinePlus related topics:  Depression

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: TREATMENT OF POST-TBI DEPRESSION – A RANDOMIZED CLINICAL TRIAL

Further study details as provided by Mount Sinai School of Medicine:
Primary Outcomes: Reduced depression (Beck Depression Inventory- Second Edition)
Secondary Outcomes: Increased participation (Participation Objective, Participation Subjective); Improved quality of life (Life-3).
Expected Total Enrollment:  102

Study start: November 2005;  Expected completion: September 2009
Last follow-up: March 2009;  Data entry closure: August 2009

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.

Eligibility

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

- Being 18-55 years 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 12 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; • Having a current DSM-IV diagnosis of Major depressive disorder (MDD), with or without co-occurring anxiety; • 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; and • 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 six months or more.

Exclusion Criteria:

- History of a prior or current psychotic disorder; • Current substance abuse diagnosis; • Pre-existing neurological disorder, including brain injury from an etiology other than trauma; • History of mental retardation; • Lack of capacity to sign informed consent; • Being actively suicidal; • Taking antidepressant medications for less than six months; or • Having any changes in antidepressant medications in the last six months.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00233116

Wayne A Gordon, Ph.D.       wayne.gordon@mssm.edu

New York
      Mount Sinai School of Medicine, New York,  New York,  10029=6574,  United States

Study chairs or principal investigators

Wayne A Gordon, Ph.D.,  Principal Investigator,  Mount Sinai School of Medicine   

More Information

Study description

Study ID Numbers:  04-0782; #H133B040033
Last Updated:  December 8, 2005
Record first received:  October 3, 2005
ClinicalTrials.gov Identifier:  NCT00233116
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10



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