Life Improvement Following Traumatic Brain Injury

NCT00878150 | Completed

• 3 other identifiers: 40378 G1R21HD053736-01A1H133G070016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury; Depression

Keywords

traumatic brain injury; TBI; head injury; brain injury; depression; major depressive disorder; cognitive behavioral therapy; CBT; counseling

Outcome Measures

Primary Outcomes (2)

• Hamilton Rating Scale for Depression (HAM-D)

  16 weeks, 24 weeks

• Symptom Checklist-20 (SCL-20)

  16 weeks, 24 weeks

Secondary Outcomes (8)

• 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

Study Arms (3)

Telephone-based CBT

EXPERIMENTAL

\- 12 counseling sessions over 16 weeks over the telephone

Behavioral: Telephone Cognitive Behavioral Therapy

In-person CBT

EXPERIMENTAL

\- 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

3: Usual care

NO INTERVENTION

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

Interventions

In-person Cognitive Behavioral Therapy BEHAVIORAL

12 sessions of CBT delivered in-person over 16 weeks

Also known as: In-person CBT, Counseling, CBT

In-person CBT

Telephone Cognitive Behavioral Therapy BEHAVIORAL

12 sessions of telephone-based CBT over 16 weeks

Also known as: Telephone CBT, CBT, Counseling

Telephone-based CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• 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.

  PMID: 26291629 DERIVED

• 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.

  PMID: 25072405 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Brain Injuries, Traumatic; Depression; Craniocerebral Trauma; Brain Injuries; Depressive Disorder, Major

Interventions

Counseling

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2009
• First Posted: April 8, 2009
• Study Start: September 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: September 1, 2013
• Last Updated: October 18, 2013

Record last verified: 2013-10

Locations

US (1)