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Life Improvement Following Traumatic Brain Injury (LIFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00878150
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : October 18, 2013
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
U.S. Department of Education
Information provided by (Responsible Party):
Jesse Fann, University of Washington

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 16 weeks, 24 weeks ]
  2. Symptom Checklist-20 (SCL-20) [ Time Frame: 16 weeks, 24 weeks ]

Secondary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 16 weeks, 24 weeks ]
  2. Head Injury Symptom Checklist [ Time Frame: 16 weeks, 24 weeks ]
  3. Structured Clinical Interview for DSM-IV (SCID)- Current MDD only [ Time Frame: 16 weeks, 24 weeks ]
  4. Automatic Thoughts Questionnaire [ Time Frame: 16 weeks ]
  5. Dysfunctional Attitudes Scale [ Time Frame: 16 weeks ]
  6. Environmental Reward Observation Scale (EROS) [ Time Frame: 16 weeks ]
  7. Medical Outcome Short Form- 36 (SF-36) [ Time Frame: 16 weeks, 24 weeks ]
  8. Sheehan Disability Scale [ Time Frame: 16 weeks, 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00878150

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United States, Washington
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
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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
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jesse Fann, Professor, University of Washington Identifier: NCT00878150    
Other Study ID Numbers: 40378 G
1R21HD053736-01A1 ( U.S. NIH Grant/Contract )
H133G070016 ( Other Grant/Funding Number: NIDRR )
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: October 18, 2013
Last Verified: October 2013
Keywords provided by Jesse Fann, University of Washington:
traumatic brain injury
head injury
brain injury
major depressive disorder
cognitive behavioral therapy
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System