LIFT: Life Improvement Following Traumatic Brain Injury

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT00878150

Collaborator

National Institutes of Health (NIH) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), U.S. Department of Education (U.S. Fed)

100

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Depression	Behavioral: In-person Cognitive Behavioral Therapy Behavioral: Telephone Cognitive Behavioral Therapy	N/A

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Cognitive Behavioral Therapy for Depression After Traumatic Brain Injury

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telephone-based CBT - 12 counseling sessions over 16 weeks over the telephone	Behavioral: Telephone Cognitive Behavioral Therapy 12 sessions of telephone-based CBT over 16 weeks Other Names: Telephone CBT CBT Counseling
Experimental: In-person CBT - 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 12 sessions of CBT delivered in-person over 16 weeks Other Names: In-person CBT Counseling CBT
No Intervention: 3: Usual care - No counseling sessions as part of this study, however you are free to pursue regular medical care and counseling outside of this study

Arm

Intervention/Treatment

Experimental: Telephone-based CBT

- 12 counseling sessions over 16 weeks over the telephone

Behavioral: Telephone Cognitive Behavioral Therapy

12 sessions of telephone-based CBT over 16 weeks

Other Names:

Telephone CBT

CBT

Counseling

Experimental: In-person CBT

- 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

12 sessions of CBT delivered in-person over 16 weeks

Other Names:

In-person CBT

Counseling

CBT

No Intervention: 3: Usual care

- No counseling sessions as part of this study, however you are free to pursue regular medical care and counseling outside of this study

Outcome Measures

Primary Outcome Measures

Hamilton Rating Scale for Depression (HAM-D) [16 weeks, 24 weeks]
Symptom Checklist-20 (SCL-20) [16 weeks, 24 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington School of Medicine	Seattle	Washington	United States	98195

Sponsors and Collaborators

University of Washington
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
U.S. Department of Education

Investigators

Principal Investigator: 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