| ID | Type | Description | Link |
|---|---|---|---|
| H133B040033 |
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| Name | Class |
|---|---|
| U.S. Department of Education | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1 | Experimental | 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. |
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| Treatment Arm 2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Remission of depression (DSM-IV diagnosis no longer met) | baseline | |
| Remission of depression (DSM-IV diagnosis no longer met) | one week after treatment completion | |
| Remission of depression (DSM-IV diagnosis no longer met) | six months after treatment completion | |
| Remission of depression (DSM-IV diagnosis no longer met) | one year after treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| Increased participation (Participation Objective, Participation Subjective) | baseline | |
| Improved quality of life (Life-3). | baseline | |
| Increased participation (Participation Objective, Participation Subjective) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne Gordon, Ph.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029-6574 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25370439 | Derived | 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. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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. |
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| one week after treatment completion |
| Increased participation (Participation Objective, Participation Subjective) | six months after treatment completion |
| Increased participation (Participation Objective, Participation Subjective) | one year after treatment completion |
| Improved quality of life (Life-3). | one week after treatment completion |
| Improved quality of life (Life-3). | six months after treatment completion |
| Improved quality of life (Life-3). | one year after treatment completion |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |