Life Improvement Following Traumatic Brain Injury

Study Overview
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Brief Summary
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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).

Detailed Description
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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 develop CBT for for Major Depression Disorder (MDD) in persons with TBI that can be delivered in-person or via the telephone conduct a trial of CBT-TBI delivered either in-person or via telephone versus care as usual 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.

Official Title
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Cognitive Behavioral Therapy for Depression After Traumatic Brain Injury

Conditions
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Traumatic Brain Injury, Depression

Intervention / Treatment
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* Behavioral: In-person Cognitive Behavioral Therapy
* Behavioral: Telephone Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hospitalized for TBI within the last 10 years, and at least one month post-injury sustained a complicated mild to severe TBI as indicated by Glasgow Coma Scale score of 3-12 or had documented intracranial abnormalities on CT scan or had post-traumatic amnesia (PTA) of at least 7 days meet screening criteria for major depression speak English fluently resides in any of the the 50 United States Exclusion Criteria: does not have a telephone does not have a stable address history of bipolar disorder or schizophrenia, or current psychosis or suicidal intent current alcohol or substance dependence (within last month) evidence of significant cognitive impairment on neuropsychological testing started on an antidepressant medication within 6 weeks or planning to start on an antidepressant within the 16-week study currently in psychotherapy for depression or plan to start psychotherapy for depression within the 16-week study period refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone-based CBT<br>- 12 counseling sessions over 16 weeks over the telephone | Behavioral: Telephone Cognitive Behavioral Therapy<br>* 12 sessions of telephone-based CBT over 16 weeks<br>* Other names: Counseling;|
| Experimental: In-person CBT<br>- 12 counseling sessions over 16 weeks at either Harborview Medical Center or the University of Washington Medical Center in Seattle, WA | Behavioral: In-person Cognitive Behavioral Therapy<br>* 12 sessions of CBT delivered in-person over 16 weeks<br>* Other names: CBT;|
| No Intervention: 3: Usual care<br>- No counseling sessions as part of this study, however you are free to pursue regular medical care and counseling outside of this study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HAM-D) |  | 16 weeks, 24 weeks | 
| Symptom Checklist-20 (SCL-20) |  | 16 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury, TBI, head injury, brain injury, depression, major depressive disorder, cognitive behavioral therapy, CBT, counseling