Treatment of Post-TBI Depression

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00211835
First received: September 13, 2005
Last updated: September 20, 2013
Last verified: September 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Post-TBI Depression - A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Remission of depression (DSM-IV diagnosis no longer met) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Remission of depression (DSM-IV diagnosis no longer met) [ Time Frame: one week after treatment completion ] [ Designated as safety issue: No ]
  • Remission of depression (DSM-IV diagnosis no longer met) [ Time Frame: six months after treatment completion ] [ Designated as safety issue: No ]
  • Remission of depression (DSM-IV diagnosis no longer met) [ Time Frame: one year after treatment completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increased participation (Participation Objective, Participation Subjective) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Improved quality of life (Life-3). [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Increased participation (Participation Objective, Participation Subjective) [ Time Frame: one week after treatment completion ] [ Designated as safety issue: No ]
  • Increased participation (Participation Objective, Participation Subjective) [ Time Frame: six months after treatment completion ] [ Designated as safety issue: No ]
  • Increased participation (Participation Objective, Participation Subjective) [ Time Frame: one year after treatment completion ] [ Designated as safety issue: No ]
  • Improved quality of life (Life-3). [ Time Frame: one week after treatment completion ] [ Designated as safety issue: No ]
  • Improved quality of life (Life-3). [ Time Frame: six months after treatment completion ] [ Designated as safety issue: No ]
  • Improved quality of life (Life-3). [ Time Frame: one year after treatment completion ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: November 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm 1
Individual psychotherapy focused on identifying and correcting maladaptive cognitions and behaviors with the goal of improving mood. The intervention has adapted CBT specifically to address cognitive deficits associated with TBI, which compound the cognitive distortions typical of depression. CBT therapists embed compensatory strategies within treatment sessions to address cognitive limitations of each participant.
Behavioral: Cognitive behavioral therapy
Individual psychotherapy focused on identifying and correcting maladaptive cognitions and behaviors with the goal of improving mood. The intervention has adapted CBT specifically to address cognitive deficits associated with TBI, which compound the cognitive distortions typical of depression. CBT therapists embed compensatory strategies within treatment sessions to address cognitive limitations of each participant.
Experimental: Treatment Arm 2
A client-centered individual psychotherapy treatment approach designed to address depressive disorders commonly experienced by individuals following a TBI. In line with traditional supportive psychotherapy approaches, the objective of SPT is to improve the individual's ability to deal with problems of daily living more effectively through problem identification, praise, reassurance, encouragement, psychoeducation, advice, anticipatory guidance, and expanding awareness.
Behavioral: Supportive psychotherapy
A client-centered individual psychotherapy treatment approach designed to address depressive disorders commonly experienced by individuals following a TBI. In line with traditional supportive psychotherapy approaches, the objective of SPT is to improve the individual's ability to deal with problems of daily living more effectively through problem identification, praise, reassurance, encouragement, psychoeducation, advice, anticipatory guidance, and expanding awareness.

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 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Mount Sinai School of Medicine
U.S. Department of Education
Investigators
Principal Investigator: Wayne Gordon, Ph.D. Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00211835     History of Changes
Obsolete Identifiers: NCT00233116
Other Study ID Numbers: GCO 04-0782, H133B040033
Study First Received: September 13, 2005
Last Updated: September 20, 2013
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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Brain Injuries
Wounds and Injuries
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 31, 2014