Clinical trial NCT00211835: Treatment of Post-TBI Depression
Official title: Treatment of Post-TBI Depression - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Depression
Keywords: TBI
traumatic brain injury
depression
cognitive behavioral therapy
supportive psychotherapy
psychotherapy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2005-09-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Remission of depression (DSM-IV diagnosis no longer met)
timeFrame: baseline
measure: Remission of depression (DSM-IV diagnosis no longer met)
timeFrame: one week after treatment completion
measure: Remission of depression (DSM-IV diagnosis no longer met)
timeFrame: six months after treatment completion
measure: Remission of depression (DSM-IV diagnosis no longer met)
timeFrame: one year after treatment completion
Secondary outcomes:
measure: Increased participation (Participation Objective, Participation Subjective)
timeFrame: baseline
measure: Improved quality of life (Life-3).
timeFrame: baseline
measure: Increased participation (Participation Objective, Participation Subjective)
timeFrame: one week after treatment completion
measure: Increased participation (Participation Objective, Participation Subjective)
timeFrame: six months after treatment completion
measure: Increased participation (Participation Objective, Participation Subjective)
timeFrame: one year after treatment completion
measure: Improved quality of life (Life-3).
timeFrame: one week after treatment completion
measure: Improved quality of life (Life-3).
timeFrame: six months after treatment completion
measure: Improved quality of life (Life-3).
timeFrame: one year after treatment completion
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Wayne Gordon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashman T, Cantor JB, Tsaousides T, Spielman L, Gordon W. Comparison of cognitive behavioral therapy and supportive psychotherapy for the treatment of depression following traumatic brain injury: a randomized controlled trial. J Head Trauma Rehabil. 2014 Nov-Dec;29(6):467-78. doi: 10.1097/HTR.0000000000000098.