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Treatment of Post-TBI Depression

This study is currently recruiting participants.
Verified by Mount Sinai School of Medicine, May 2007

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: NCT00211835
  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
Traumatic Brain Injury
Depression
Behavioral: Cognitive behavioral therapy
Behavioral: Supportive psychotherapy

MedlinePlus related topics:   Depression    Head and Brain Injuries   

U.S. FDA Resources

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 Outcome Measures:
  • Reduced depression (Beck Depression Inventory- Second Edition)

Secondary Outcome Measures:
  • Increased participation (Participation Objective, Participation Subjective)
  • Improved quality of life (Life-3).

Estimated Enrollment:   102
Study Start Date:   November 2005
Estimated Study Completion Date:   March 2009

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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
  • 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
  • Having any changes in antidepressant medications in the last six months
  • Currently taking antidepressant medication (including monamine oxidase inhibitors (MOAs) or tricyclic antidepressants (TCAs)
  • Unwilling to abstain from seeking new psychosocial or pharmacologic treatments during the course of the study
  • Currently in psychotherapy
  • Active suicidal plans and/or requiring hospitalization
  • Currently experiencing other serious medical illness
  • Currently pregnant or breast feeding
  • Mass brain lesions or other neurological diagnoses other than TBI
  • History of current or past psychosis or mania
  • Current substance abuse
  • History of clinically significant liver or renal disease
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211835

Contacts
Contact: Wayne Gordon     wayne.gordon@mssm.edu    

Locations
United States, New York
Mount Sinai School of Medicine     Recruiting
      New York, New York, United States, 10029-6574
      Contact: Wayne Gordon         wayne.gordon@mssm.edu    

Sponsors and Collaborators
Mount Sinai School of Medicine
National Institute of Disability and Rehabilitation Research

Investigators
Principal Investigator:     Wayne Gordon, Ph.D.     Mount Sinai School of Medicine    
  More Information


Study Description  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   GCO 04-0782, H133B040033
First Received:   September 13, 2005
Last Updated:   May 1, 2007
ClinicalTrials.gov Identifier:   NCT00211835
Health Authority:   United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
TBI  
traumatic brain injury  
depression  
cognitive behavioral therapy
supportive psychotherapy
psychotherapy

Study placed in the following topic categories:
Craniocerebral Trauma
Depression
Mental Disorders
Wounds and Injuries
Mood Disorders
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Depressive Disorder
Brain Injuries
Behavioral Symptoms

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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