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Treatment of Post-TBI Depression

Primary Purpose

Traumatic Brain Injury, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Supportive psychotherapy
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring TBI, traumatic brain injury, depression, cognitive behavioral therapy, supportive psychotherapy, psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Arm 1

Treatment Arm 2

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Increased participation (Participation Objective, Participation Subjective)
Improved quality of life (Life-3).
Increased participation (Participation Objective, Participation Subjective)
Increased participation (Participation Objective, Participation Subjective)
Increased participation (Participation Objective, Participation Subjective)
Improved quality of life (Life-3).
Improved quality of life (Life-3).
Improved quality of life (Life-3).

Full Information

First Posted
September 13, 2005
Last Updated
September 20, 2013
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT00211835
Brief Title
Treatment of Post-TBI Depression
Official Title
Treatment of Post-TBI Depression - A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Depression
Keywords
TBI, traumatic brain injury, depression, cognitive behavioral therapy, supportive psychotherapy, psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm 1
Arm Type
Experimental
Arm 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 Title
Treatment Arm 2
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Supportive psychotherapy
Intervention 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.
Primary Outcome Measure Information:
Title
Remission of depression (DSM-IV diagnosis no longer met)
Time Frame
baseline
Title
Remission of depression (DSM-IV diagnosis no longer met)
Time Frame
one week after treatment completion
Title
Remission of depression (DSM-IV diagnosis no longer met)
Time Frame
six months after treatment completion
Title
Remission of depression (DSM-IV diagnosis no longer met)
Time Frame
one year after treatment completion
Secondary Outcome Measure Information:
Title
Increased participation (Participation Objective, Participation Subjective)
Time Frame
baseline
Title
Improved quality of life (Life-3).
Time Frame
baseline
Title
Increased participation (Participation Objective, Participation Subjective)
Time Frame
one week after treatment completion
Title
Increased participation (Participation Objective, Participation Subjective)
Time Frame
six months after treatment completion
Title
Increased participation (Participation Objective, Participation Subjective)
Time Frame
one year after treatment completion
Title
Improved quality of life (Life-3).
Time Frame
one week after treatment completion
Title
Improved quality of life (Life-3).
Time Frame
six months after treatment completion
Title
Improved quality of life (Life-3).
Time Frame
one year after treatment completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Gordon, Ph.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25370439
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.
Results Reference
derived

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Treatment of Post-TBI Depression

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