Expired Study
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New York, New York 10029


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.


Study summary:

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.


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


Study is Available At:


Original ID:

GCO 04-0782


NCT ID:

NCT00211835


Secondary ID:

H133B040033


Study Acronym:


Brief Title:

Treatment of Post-TBI Depression


Official Title:

Treatment of Post-TBI Depression - A Randomized Clinical Trial


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mount Sinai School of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

75


Enrollment Type:

Actual


Overall Contact Information

Official Name:Wayne Gordon, Ph.D.
Principal Investigator
Mount Sinai School of Medicine

Study Dates

Start Date:November 2005
Completion Date:December 2010
Completion Type:Actual
Primary Completion Date:December 2010
Primary Completion Type:Actual
Verification Date:September 2013
Last Changed Date:September 20, 2013
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Remission of depression (DSM-IV diagnosis no longer met)
Time Frame:baseline
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Remission of depression (DSM-IV diagnosis no longer met)
Time Frame:one week after treatment completion
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Remission of depression (DSM-IV diagnosis no longer met)
Time Frame:six months after treatment completion
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Remission of depression (DSM-IV diagnosis no longer met)
Time Frame:one year after treatment completion
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Increased participation (Participation Objective, Participation Subjective)
Time Frame:baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Improved quality of life (Life-3).
Time Frame:baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Increased participation (Participation Objective, Participation Subjective)
Time Frame:one week after treatment completion
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Increased participation (Participation Objective, Participation Subjective)
Time Frame:six months after treatment completion
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Increased participation (Participation Objective, Participation Subjective)
Time Frame:one year after treatment completion
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Improved quality of life (Life-3).
Time Frame:one week after treatment completion
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Improved quality of life (Life-3).
Time Frame:six months after treatment completion
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Improved quality of life (Life-3).
Time Frame:one year after treatment completion
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Cognitive behavioral therapy
Description: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.
Arm Name:Treatment Arm 1
Intervention Type:Behavioral
Name:Supportive psychotherapy
Description: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.
Arm Name:Treatment Arm 2

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment Arm 2
Description: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.
Study Arm Type:Experimental
Arm Name:Treatment Arm 1
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mount Sinai School of Medicine
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:U.S. Department of Education

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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