Study manuals provide the detailed methodology of key research trials. Making this information available allows others to replicate or extend the research in other settings, thereby expanding the body of knowledge and evidence in an area of research.
The Defense and Veterans Brain Injury Center (DVBIC) created a study manual for researchers and clinicians based on the randomized controlled treatment trial — “Study of Cognitive Rehabilitation Effectiveness (SCORE)” — DVBIC completed in 2015. Review the study manual below to learn how clinicians conducted this three-year study.
Study of Cognitive Rehabilitation Effectiveness
The National Defense Authorization Act for Fiscal Year 2010 tasked the Defense and Veterans Brain Injury Center with completing a clinical trial to assess the efficacy of cognitive rehabilitation in service members and veterans who sustained a mild traumatic brain injury (TBI) while deployed in support of Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF).
DVBIC partnered with investigators at Brooke Army Medical Center in San Antonio, Texas, to execute this randomized controlled treatment trial titled “Study of Cognitive Rehabilitation Effectiveness.” The research aimed to improve the health and quality of life for service members with mild TBI, also known as concussion, through the development of empirically validated cognitive rehabilitation interventions.
The three-year study evaluated the efficacy of different types of cognitive rehabilitation interventions (computer-based, traditional and an integrated approach) for service members who were diagnosed with mild TBI during OEF or OIF and who had persistent symptoms. Outcome measures examined improvements in the following areas: cognitive functioning, post-concussion symptoms, cognitive complaints, cognitive fatigue, quality of life, health care use and work status.
Chapter 1: Study of Cognitive Rehabilitation Effectiveness Clinical Trial: Overview
Authors: Douglas B. Cooper, Ph.D., ABPP-CN; Amy O. Bowles, M.D.; Rodney D. Vanderploeg, Ph.D., ABPP-CN; David F. Tate, Ph.D.; and Jan E. Kennedy, Ph.D.
Chapter 1 provides a concise overview of the SCORE clinical trial and measures, plus the Congressional mandate for the study, and implications for the military and veterans.
Chapter 2: Psychoeducational Interventions for Persistent Post-Concussion Symptoms Following Combat-Related Mild Traumatic Brain Injury (SCORE Arm 1)
Authors: Heather Belanger, Ph.D, ABPP-CN; Tracy S. Kretzmer, Ph.D.; Rodney D. Vanderploeg, Ph.D., ABPP-CN; Amy O. Bowles, M.D.; Michelle A. Lindsay, ANP-BC; and Douglas B. Cooper, Ph.D., ABPP-CN
Chapter 2 summarizes the psychoeducational interventions used for the control group in the first SCORE treatment arm. This educational material has been specifically adapted for use with service members and veterans who experience a more chronic course of symptoms following combat-related concussion. Section 1 explains the background of psychoeducation in the treatment of mild TBI, and Section 2 provides the psychoeducational tool, called the client’s guide to recovery.
Chapter 3: Computerized Cognitive Rehabilitation Interventions for Persistent Symptoms Following Mild Traumatic Brain Injury (SCORE Arm 2)
Authors: Anne E. Bunner, Ph.D.; Henry W. Mahncke, M.D.; Catherine N. Stasio; Amy O. Bowles, M.D.; Christy Muncrief, CTRS; Michelle A. Lindsay, ANP-BC; Douglas B. Cooper, Ph.D., ABPP-CN
Chapter 3 describes the computerized cognitive rehabilitation interventions used in the second SCORE treatment arm, including clinician procedures and Brainworks TM content.
Chapter 4: Traditional Cognitive Rehabilitation for Persistent Symptoms Following Mild Traumatic Brain Injury (SCORE Arm 3)
Authors: Melissa R. Ray, CCC-SLP; M. Marina LeBlanc, OTR/L; R. Kevin Manning, Ph.D., CCC-SLP; Christine S. Fox, CCC-SLP; Christopher J. Gillis, OTR/L; Micaela V. Cornis-Pop, Ph.D.; Donald L. MacLennan, M.A., CCC-SLP; Linda M. Picon, M.C.D., CCC-SLP; and Deborah Voydetich, OTR/L, SCLV
Chapter 4 is divided into two clinician guides and two client manuals. Parts I and II describe SCORE treatment Arm 3 individual cognitive rehabilitation interventions, while Parts III and IV combine Arm 3 and Arm 4 interventions.
- Part I: Clinician Guide to Individual Cognitive Rehabilitation Interventions
- Part II: Client Manual for Individual Cognitive Rehabilitation Interventions
- Part III: Clinician Guide to Arm 3 Traditional & Arm 4 Integrated Cognitive Group Interventions
- Part IV: Client Manual for Arm 3 Traditional & Arm 4 Integrated Cognitive Group Interventions
Chapter 5: Integrated Behavioral Health and Cognitive Rehabilitation Interventions for Persistent Symptoms Following Mild Traumatic Brain Injury (SCORE Arm 4)
Authors: Melissa R. Ray, CCC-SLP; M. Marina LeBlanc, OTR/L; R. Kevin Manning, Ph.D., CCC-SLP; Christine S. Fox, CCC-SLP; Christopher J. Gillis, OTR/L; Jon Grizzle, Ph.D.; Laurence P. Perotti, Ph.D.; Rodney D. Vanderploeg, Ph.D., ABPP-CN; Micaela V. Cornis-Pop, Ph.D.; Donald L. MacLennan, M.A., CCC-SLP; Linda M. Picon, M.C.D., CCC-SLP; Deborah Voydetich, OTR/L, SCLV; and Douglas B. Cooper, Ph.D., ABPP-CN
Chapter 5 describes the fourth SCORE treatment arm, which integrates behavioral health and cognitive rehabilitation interventions for individual and group therapy.
- Part I: Clinician Guide to Individual Cognitive Rehabilitation Interventions
- Part II: Client Manual for Individual Cognitive Rehabilitation Interventions
- Part III: Clinician Guide to Arm 3 Traditional & Arm 4 Integrated Cognitive Group Interventions
- Part IV: Client Manual for Arm 3 Traditional & Arm 4 Integrated Cognitive Group Interventions
- Part V: Clinician Guide to Individual Behavioral Health Therapy Protocol
- Part VI: Client Manual for Individual Behavioral Health Therapy Protocol
- Part VII: Mindfulness
- Part VIII: Client Manual for Group Behavioral Health Interventions
Chapter 6: Implementation of the SCORE Clinical Trial in DoD and VA Healthcare Settings: Administrative Considerations
Authors: Jacob Kean, Ph.D., CCC-SLP; Amy O. Bowles, M.D.; Douglas B. Cooper, Ph.D., ABPP-CN; and Alan McGuire, Ph.D., HSPP
Chapter 6 reviews SCORE implementation work at Washington University Center for Implementation Studies, publication of the Fidelity Tool for clinicians and researchers, and special issues from an administrative/clinic chief viewpoint.
Chapter 7: Imaging Support for the Study of Cognitive Rehabilitation Effectiveness Clinical Trial: Overview
Authors: David F. Tate, Ph.D.; Gerald York, M.D.; and Jeffrey Lewis, M.D., Ph.D.
Chapter 7 is a concise overview of iSCORE imaging modalities and approaches, plus technical details of magnet, software and image acquisition.
Acknowledgements
The SCORE study team would like to express our sincere gratitude to the men and women in uniform who participated in this study. We are humbled by the trust you placed in us to provide the best care possible and to learn more about how to help those with traumatic brain injuries who follow you.
We would like to acknowledge the special contributions and leadership skills of Janel Shelton, the SCORE study coordinator, and the dedication and professionalism of her staff, Sylvia Davis and Gina Garcia. Their efforts were essential to the success of the study. In addition, we are grateful to Michael W. McDonnell for his valuable contributions to Chapter 3.
We would like to acknowledge our editors for their dedicated work editing and reviewing the SCORE manual: Amy O. Bowles, M.D.; Douglas B. Cooper, Ph.D., ABPP-CN; Merrie E. Aiken, B.S., Medical Writer/Editor, Defense and Veterans Brain Injury Center (DVBIC); Kelly J. Miller, M.P.H., Writer/Editor, DVBIC; Sean T. Manion, Ph.D., DVBIC.
Finally, we would like to thank DVBIC, which, under the leadership of Col. Jamie Grimes in 2010, identified and entrusted us to execute this congressionally mandated study, and provided us with additional staffing and research facilitation.