Life Improvement Following Traumatic Brain Injury (LIFT)
Tracking Information | |||||||||
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First Received Date ICMJE | April 6, 2009 | ||||||||
Last Updated Date | July 19, 2012 | ||||||||
Start Date ICMJE | September 2007 | ||||||||
Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00878150 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Life Improvement Following Traumatic Brain Injury | ||||||||
Official Title ICMJE | Cognitive Behavioral Therapy for Depression After Traumatic Brain Injury | ||||||||
Brief Summary | The purpose of this pilot 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). |
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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:
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
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:
Outcomes are assessed by a blinded research assistant at 8, 16, and 24 weeks after baseline. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | |||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||
Enrollment ICMJE | 100 | ||||||||
Estimated Completion Date | December 2012 | ||||||||
Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00878150 | ||||||||
Other Study ID Numbers ICMJE | 40378 G, 1R21HD053736-01A1, H133G070016 | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Jesse Fann, University of Washington | ||||||||
Study Sponsor ICMJE | University of Washington | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | University of Washington | ||||||||
Verification Date | July 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |