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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD053736-01A1 | U.S. NIH Grant/Contract | View source | |
| H133G070016 | Other Grant/Funding Number | NIDRR |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| U.S. Department of Education | FED |
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The purpose of this study is to test the effectiveness of a telephone-based and in-person Cognitive Behavioral Therapy (CBT) intervention for treating Major Depressive Disorder (MDD) following Traumatic Brain Injury. Participants are randomly assigned to receive one of the following: 1) Telephone-based CBT, 2) In-person CBT, or 3) Usual care (control).
Major Depressive Disorder (MDD) is the most prevalent psychiatric disorder in persons with traumatic brain injury (TBI) and is most common during the first several years after injury. MDD following TBI is associated with poor behavioral, health, and functional outcomes. While neurological factors contribute somewhat to the development of MDD in this population, there is evidence that numerous psychological, social and vocational factors also contribute.
There are also multiple barriers to effective treatment of MDD in persons with TBI, including:
The investigators are conducting a three arm trial of Cognitive Behavioral Therapy (CBT) to treat Major Depression Disorder (MDD) that emerges within the first 10 years after complicated mild to severe traumatic brain injury (TBI). The overall objective of the study is to develop a 12-session telephone-based and in-person CBT program for people with TBI (CBT-TBI), and to evaluate its feasibility, acceptability, and effectiveness.
The investigators project aims are to
Participants are randomized to one of three groups: (1) 12 semi-weekly sessions of telephone-based CBT for depression provided by a study therapist, (2) 12 semi-weekly sessions of in-person CBT for depression provided by a study therapist, or (3) Usual Care (control). Randomization is stratified by injury severity to ensure equal proportions in each treatment group. Participants choose one of three randomization options that includes the groups to which he/she would like to be randomized:
Outcomes are assessed by a blinded research assistant at 8, 16, and 24 weeks after baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone-based CBT | Experimental | - 12 counseling sessions over 16 weeks over the telephone |
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| In-person CBT | Experimental | - 12 counseling sessions over 16 weeks at either Harborview Medical Center or the University of Washington Medical Center in Seattle, WA |
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| 3: Usual care | No Intervention | - No counseling sessions as part of this study, however you are free to pursue regular medical care and counseling outside of this study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-person Cognitive Behavioral Therapy | Behavioral | 12 sessions of CBT delivered in-person over 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression (HAM-D) | 16 weeks, 24 weeks | |
| Symptom Checklist-20 (SCL-20) | 16 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | 16 weeks, 24 weeks | |
| Head Injury Symptom Checklist | 16 weeks, 24 weeks | |
| Structured Clinical Interview for DSM-IV (SCID)- Current MDD only |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesse R Fann, MD, MPH | University of Washington School of Medicine, Departments of Psychiatry & Behavioral Sciences and Rehabilitation Medicine | Principal Investigator |
| Charles H. Bombardier, PhD | University of Washington School of Medicine, Department of Rehabilitation Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington School of Medicine | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26291629 | Derived | Dyer JR, Williams R, Bombardier CH, Vannoy S, Fann JR. Evaluating the Psychometric Properties of 3 Depression Measures in a Sample of Persons With Traumatic Brain Injury and Major Depressive Disorder. J Head Trauma Rehabil. 2016 May-Jun;31(3):225-32. doi: 10.1097/HTR.0000000000000177. | |
| 25072405 | Derived | Fann JR, Bombardier CH, Vannoy S, Dyer J, Ludman E, Dikmen S, Marshall K, Barber J, Temkin N. Telephone and in-person cognitive behavioral therapy for major depression after traumatic brain injury: a randomized controlled trial. J Neurotrauma. 2015 Jan 1;32(1):45-57. doi: 10.1089/neu.2014.3423. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D003863 | Depression |
| D006259 | Craniocerebral Trauma |
| D001930 | Brain Injuries |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Telephone Cognitive Behavioral Therapy | Behavioral | 12 sessions of telephone-based CBT over 16 weeks |
|
|
| 16 weeks, 24 weeks |
| Automatic Thoughts Questionnaire | 16 weeks |
| Dysfunctional Attitudes Scale | 16 weeks |
| Environmental Reward Observation Scale (EROS) | 16 weeks |
| Medical Outcome Short Form- 36 (SF-36) | 16 weeks, 24 weeks |
| Sheehan Disability Scale | 16 weeks, 24 weeks |
| D014947 | Wounds and Injuries |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D005159 | Health Care Facilities Workforce and Services |