Contemporary Clinical Trials Communications (Dec 2020)

Use of a randomized clinical trial design to study cognitive rehabilitation approaches to enhance warfighter performance

  • Ida Babakhanyan,
  • Melissa Jensen,
  • Rosemay A. Remigio-Baker,
  • Paul Sargent,
  • Jason M. Bailie

Journal volume & issue
Vol. 20
p. 100660

Abstract

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Within the military, cognitive readiness is essential to ensure the warfighter can return to highly demanding combat training and deployment operations. The warfighter must be able to make split second decisions and adapt to new tools and environments. After a traumatic brain injury, clinicians helping the warfighter must have techniques that address warfighter cognitive readiness. Current rehabilitation for cognitive complaints used in military medicine are modeled after civilian therapies which focus on remediating moderate to severe impairment through building compensatory strategies. This traditional approach to cognitive rehabilitation does not translate well to mild traumatic brain injury (mTBI) where impairments are subtle, nor does it meet the needs of our warfighters in deployed and combat training environments. Challenging our current methods is critical in adapting to the needs of this highly valued population to ensure that our warfighters are able to carry out mission critical decision making. Here we present a review of our best current practices for cognitive rehabilitation, describe the limitations our traditional approaches impose for mTBI in military personnel, and present an alternative treatment called Strategic Memory Advanced Reasoning Training (SMART) that can be adopted through a randomized clinical trial design. We propose directly comparing traditional treatment approaches with a novel cognitive rehabilitation strategy which has been well validated outside of the military setting. Procedures were developed to execute this clinical trial in a way that is most relevant to the study population by establishing ecologically valid outcome metrics.