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: * under-diagnosis and under-treatment 20lack of access to care due to mobility, transportation and health care benefit limitations * TBI neurocognitive impairments * comorbid medical and psychiatric problems, including substance abuse * stressors such as lack of social support and work instability * inaccurate beliefs about depression and its treatment among TBI survivors. 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 1. develop CBT for for Major Depression Disorder (MDD) in persons with TBI that can be delivered in-person or via the telephone 2. conduct a trial of CBT-TBI delivered either in-person or via telephone versus care as usual 3. refine the intervention and plan a definitive RCT of CBT-TBI if response rate is sufficient. 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: * Option 1: Telephone counseling verses usual care * Option 2: In-person counseling verses usual care * Option 3: In-person counseling verses Telephone counseling verses usual care Outcomes are assessed by a blinded research assistant at 8, 16, and 24 weeks after baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
12 sessions of CBT delivered in-person over 16 weeks
12 sessions of telephone-based CBT over 16 weeks
University of Washington School of Medicine
Seattle, Washington, United States
Hamilton Rating Scale for Depression (HAM-D)
Time frame: 16 weeks, 24 weeks
Symptom Checklist-20 (SCL-20)
Time frame: 16 weeks, 24 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 16 weeks, 24 weeks
Head Injury Symptom Checklist
Time frame: 16 weeks, 24 weeks
Structured Clinical Interview for DSM-IV (SCID)- Current MDD only
Time frame: 16 weeks, 24 weeks
Automatic Thoughts Questionnaire
Time frame: 16 weeks
Dysfunctional Attitudes Scale
Time frame: 16 weeks
Environmental Reward Observation Scale (EROS)
Time frame: 16 weeks
Medical Outcome Short Form- 36 (SF-36)
Time frame: 16 weeks, 24 weeks
Sheehan Disability Scale
Time frame: 16 weeks, 24 weeks
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