Open Access Study protocol

Evaluating the effectiveness of reasoning training in military and civilian chronic traumatic brain injury patients: study protocol

Daniel C Krawczyk12*, Carlos Marquez de la Plata12, Guido F Schauer1, Asha K Vas1, Molly Keebler1, Stephanie Tuthill1, Claire Gardner1, Tiffani Jantz1, Weikei Yu1 and Sandra B Chapman1

Author Affiliations

1 Center for BrainHealth®, The University of Texas at Dallas, 2200 Mockingbird Lane, Dallas, TX, 75235, USA

2 Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, NE 210, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA

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Trials 2013, 14:29  doi:10.1186/1745-6215-14-29

Published: 30 January 2013

Abstract

Background

Individuals who sustain traumatic brain injuries (TBIs) often continue to experience significant impairment of cognitive functions mediated by the prefrontal cortex well into chronic stages of recovery. Traditional brain training programs that focus on improving specific skills fall short of addressing integrative functions that draw upon multiple higher-order processes critical for social and vocational integration. In the current study, we compare the effects of two short-term, intensive, group-based cognitive rehabilitation programs for individuals with chronic TBI. One program emphasizes learning about brain functions and influences on cognition, while the other program adopts a top-down approach to improve abstract reasoning abilities that are largely reliant on the prefrontal cortex. These treatment programs are evaluated in civilian and military veteran TBI populations.

Methods/design

One hundred individuals are being enrolled in this double-blinded clinical trial (all measures and data analyses will be conducted by blinded raters and analysts). Each individual is randomly assigned to one of two treatment conditions, with each condition run in groups of five to seven individuals. The primary anticipated outcomes are improvement in abstract reasoning and everyday life functioning, measured through behavioral tasks and questionnaires, and attention modulation, as measured by functional neuroimaging. Secondary expected outcomes include improvements in the cognitive processes of working memory, attention, and inhibitory control.

Discussion

Results of this trial will determine whether cognitive rehabilitation aimed at teaching TBI-relevant information about the brain and cognition versus training in TBI-affected thinking abilities (e.g., memory, attention, and executive functioning) can improve outcomes in chronic military and civilian TBI patient populations. It should shed light on the nature of improvements and the characteristics of patients most likely to benefit. This trial will also provide information about the sustainability of treatment-related improvements 3 months post-training.

Trial registration

ClinicalTrials.gov Identifier: NCT01552473

Keywords:
Cognitive rehabilitation; Traumatic brain injury; Neuroimaging; Neuropsychology; Reasoning; Memory; Attention