Life Improvement Following Traumatic Brain Injury (LIFT)

October 16, 2013 updated by: Jesse Fann, University of Washington

Cognitive Behavioral Therapy for Depression After Traumatic Brain Injury

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • CBT
  • Counseling
  • Telephone CBT
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:
  • CBT
  • Counseling
  • In-person 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 16 weeks, 24 weeks
16 weeks, 24 weeks
Head Injury Symptom Checklist
Time Frame: 16 weeks, 24 weeks
16 weeks, 24 weeks
Structured Clinical Interview for DSM-IV (SCID)- Current MDD only
Time Frame: 16 weeks, 24 weeks
16 weeks, 24 weeks
Automatic Thoughts Questionnaire
Time Frame: 16 weeks
16 weeks
Dysfunctional Attitudes Scale
Time Frame: 16 weeks
16 weeks
Environmental Reward Observation Scale (EROS)
Time Frame: 16 weeks
16 weeks
Medical Outcome Short Form- 36 (SF-36)
Time Frame: 16 weeks, 24 weeks
16 weeks, 24 weeks
Sheehan Disability Scale
Time Frame: 16 weeks, 24 weeks
16 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 6, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (Estimate)

April 8, 2009

Study Record Updates

Last Update Posted (Estimate)

October 18, 2013

Last Update Submitted That Met QC Criteria

October 16, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40378 G
  • 1R21HD053736-01A1 (U.S. NIH Grant/Contract)
  • H133G070016 (Other Grant/Funding Number: NIDRR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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