Trial record 17 of 17 for:    learning disabilities | national institute of child health and development

Life Improvement Following Traumatic Brain Injury (LIFT)

This study has been completed.
Sponsor:
Collaborators:
U.S. Department of Education
Information provided by (Responsible Party):
Jesse Fann, University of Washington
ClinicalTrials.gov Identifier:
NCT00878150
First received: April 6, 2009
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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 Intervention
Traumatic Brain Injury
Depression
Behavioral: In-person Cognitive Behavioral Therapy
Behavioral: Telephone Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Depression After Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Symptom Checklist-20 (SCL-20) [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Head Injury Symptom Checklist [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Structured Clinical Interview for DSM-IV (SCID)- Current MDD only [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Automatic Thoughts Questionnaire [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Dysfunctional Attitudes Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Environmental Reward Observation Scale (EROS) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Medical Outcome Short Form- 36 (SF-36) [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2007
Study Completion Date: September 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878150

Locations
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
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
  More Information

Additional Information:
No publications provided

Responsible Party: Jesse Fann, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00878150     History of Changes
Other Study ID Numbers: 40378 G, 1R21HD053736-01A1, H133G070016
Study First Received: April 6, 2009
Last Updated: October 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
traumatic brain injury
TBI
head injury
brain injury
depression
major depressive disorder
cognitive behavioral therapy
CBT
counseling

Additional relevant MeSH terms:
Depression
Depressive Disorder
Brain Injuries
Wounds and Injuries
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 28, 2014