Clinical trial NCT00878150: Life Improvement Following Traumatic Brain Injury
Official title: Cognitive Behavioral Therapy for Depression After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Depression
Keywords: traumatic brain injury
TBI
head injury
brain injury
depression
major depressive disorder
cognitive behavioral therapy
CBT
counseling
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: U.S. Department of Education
First posted: 2009-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: 16 weeks, 24 weeks
measure: Symptom Checklist-20 (SCL-20)
timeFrame: 16 weeks, 24 weeks
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 16 weeks, 24 weeks
measure: Head Injury Symptom Checklist
timeFrame: 16 weeks, 24 weeks
measure: Structured Clinical Interview for DSM-IV (SCID)- Current MDD only
timeFrame: 16 weeks, 24 weeks
measure: Automatic Thoughts Questionnaire
timeFrame: 16 weeks
measure: Dysfunctional Attitudes Scale
timeFrame: 16 weeks
measure: Environmental Reward Observation Scale (EROS)
timeFrame: 16 weeks
measure: Medical Outcome Short Form- 36 (SF-36)
timeFrame: 16 weeks, 24 weeks
measure: Sheehan Disability Scale
timeFrame: 16 weeks, 24 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
Study officials:
affiliation: University of Washington School of Medicine, Departments of Psychiatry & Behavioral Sciences and Rehabilitation Medicine
name: Jesse R Fann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington School of Medicine, Department of Rehabilitation Medicine
name: Charles H. Bombardier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.