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Completed

NCT Number: NCT00211835

Treatment of Post-TBI Depression

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029-6574, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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.

supportive psychotherapy

Behavioral

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.

Primary outcomes

  1. Remission of depression (DSM-IV diagnosis no longer met)

    Time frame: baseline

  2. Remission of depression (DSM-IV diagnosis no longer met)

    Time frame: one week after treatment completion

  3. Remission of depression (DSM-IV diagnosis no longer met)

    Time frame: six months after treatment completion

  4. Remission of depression (DSM-IV diagnosis no longer met)

    Time frame: one year after treatment completion

Secondary outcomes

  1. Increased participation (Participation Objective, Participation Subjective)

    Time frame: baseline

  2. Improved quality of life (Life-3).

    Time frame: baseline

  3. Increased participation (Participation Objective, Participation Subjective)

    Time frame: one week after treatment completion

  4. Increased participation (Participation Objective, Participation Subjective)

    Time frame: six months after treatment completion

  5. Increased participation (Participation Objective, Participation Subjective)

    Time frame: one year after treatment completion

  6. Improved quality of life (Life-3).

    Time frame: one week after treatment completion

  7. Improved quality of life (Life-3).

    Time frame: six months after treatment completion

  8. Improved quality of life (Life-3).

    Time frame: one year after treatment completion

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

Treatment of Post-TBI Depression - A Randomized Clinical Trial

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Sep 21, 2005
Registry last updated
Sep 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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