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: 1) under-diagnosis and under-treatment; 2) lack of access to care due to mobility, transportation and health care benefit limitations; 3) TBI neurocognitive impairments, 4) comorbid medical and psychiatric problems, including substance abuse; 5) stressors such as lack of social support and work instability; and 6) inaccurate beliefs about depression and its treatment among TBI survivors. Since no trials of psychotherapy for MDD have been conducted in persons with TBI, basic questions remain about what treatments are feasible, acceptable and effective in this population. Therefore, a pilot study is needed prior to conducting a randomized controlled trial in order to determine whether subject recruitment procedures, treatment adaptations for people with TBI, and an innovative treatment delivery model are promising enough to embark on a large scale study. Drawing from the successful telephone-based cognitive behavioral therapy (CBT) for depression in primary care settings developed by Simon et al. as well as our extensive experience conducting studies to improve outcomes after TBI, we will conduct a two arm pilot study of a 12-week in-person or telephone-based manualized CBT intervention for MDD adapted for persons with complicated mild, moderate or severe TBI (CBT-TBI). We will evaluate the feasibility, patient satisfaction, and therapeutic response to these two interventions as well as the logistics of data collection and methods for recruitment and retention. We will test the hypothesis that at least 40% of subjects enrolled in CBT-TBI, whether in-person or telephone-based, will respond to treatment (report a 50% decrease in Hamilton Depression Rating Scale scores at 12 weeks compared to baseline). Secondary outcomes will include depression scores at 24 weeks and health related quality of life (measured by the SF-36 physical and mental health component scores), postconcussive symptoms (measured by the Head Injury Symptom Checklist), and functional status (measured by the Functional Status Examination), compared to baseline. We will also examine whether changes in behaviors (e.g., pleasant events) or cognitions (e.g., depressive thinking) are mediators of CBT efficacy. Results from this pilot study will lead to refinements of the CBT-TBI intervention, recruitment procedures, inclusion/exclusion criteria, and sample size requirements. The pilot project will help to determine which treatment delivery model has the most potential and will culminate in the design of a randomized controlled trial of CBT-TBI to test its effectiveness in a large, representative sample of people with TBI and MDD. Significant depression is common among persons with traumatic brain injury (TBI). This preliminary study will determine if cognitive behavioral therapy administered in-person or over the telephone is feasible and effective in treating depression in people with TBI (CBT-TBI). This project will culminate in the design of a trial of CBT-TBI in a large, representative sample of people with TBI and depression. ? ? ?

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21HD053736-01A1
Application #
7254284
Study Section
Adult Psychopathology and Disorders of Aging Study Section (APDA)
Program Officer
Ansel, Beth
Project Start
2007-09-15
Project End
2009-08-31
Budget Start
2007-09-15
Budget End
2008-08-31
Support Year
1
Fiscal Year
2007
Total Cost
$234,000
Indirect Cost
Name
University of Washington
Department
Psychiatry
Type
Schools of Medicine
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
Bombardier, Charles H; Fann, Jesse R; Ludman, Evette J et al. (2017) The Relations of Cognitive, Behavioral, and Physical Activity Variables to Depression Severity in Traumatic Brain Injury: Reanalysis of Data From a Randomized Controlled Trial. J Head Trauma Rehabil 32:343-353
Fann, Jesse R; Bombardier, Charles H; Vannoy, Steven et al. (2015) Telephone and in-person cognitive behavioral therapy for major depression after traumatic brain injury: a randomized controlled trial. J Neurotrauma 32:45-57
Vaishnavi, Sandeep; Rao, Vani; Fann, Jesse R (2009) Neuropsychiatric problems after traumatic brain injury: unraveling the silent epidemic. Psychosomatics 50:198-205
Fann, Jesse R; Hart, Tessa; Schomer, Katherine G (2009) Treatment for depression after traumatic brain injury: a systematic review. J Neurotrauma 26:2383-402