Ongoing Research in Cognitive Rehabilitation The SCORE trial

Transcription

1 Ongoing Research in Cognitive Rehabilitation The SCORE trial March 16, 2011 Douglas B. Cooper, Ph.D Clinical Neuropsychologist Director, Military Brain Injury Rehabilitation Research Consortium Brooke Army Medical Center

2 Disclaimer The opinions expressed are my own and are not officially endorsed by the Department of Defense, US Army, Defense and Veterans Brain Injury Center or Brooke Army Medical Center.

3 SCORE! Study of Cognitive Rehabilitation Effectiveness Goal of the Study To improve the health and quality of life for wounded warriors with mild Traumatic Brain Injury (mtbi) injury in the line of duty in support of Operation Enduring Freedom (OEF) or Operation Iraqi Freedom (OEF) through the development of empiricallyvalidated rehabilitation interventions. Research Design Prospective, randomized control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mtbi and persistent (3-24 months post-injury) cognitive complaints. Sample size=160 (40 per arm). Four treatment arms

4 SCORE! Study Design 0 weeks 3 weeks 6 weeks 12 weeks 18 weeks Start of Treatment End of Treatment Follow-up Evaluations (Research)

5 Inclusion Criteria SCORE! Diagnosis of mtbi which occurred during deployment in support of OIF/OEF within 3-24 months prior to enrollment in the study. Presence of cognitive complaints (endorsement of 3 or greater on any of the four cognitive symptoms on the NSI). Ability to understand and communicate in English.

6 SCORE! Exclusion Criteria Medical/Psychiatric/Neurological Co-Morbidities: Blindness/low vision Uncontrolled seizure disorder Psychosis History of moderate/severe/penetrating brain injury SCI with no use of upper extremities Active participation in intensive (>5 appointments per week) treatment for amputation, burns, substance use, or psychiatric condition which would preclude full participation in an intensive cognitive rehab program Daily use of narcotic pain medications

7 How is Cognitive Rehabilitation Defined in the SCORE trial? Traditional View (Treatment Arm 3) Compensatory and Restorative Techniques Therapist-directed by skilled SLP and/or OT Individual Therapy; Group Therapy; Computer (APT-III) Non-Traditional View (Treatment Arm 2) Self-Directed Computerized Intervention

8 How is Cognitive Rehabilitation Defined in the SCORE trial? (cont.) Novel View (Treatment Arm 4) Assumption #1: Meta-analytic studies of neurocognitive functioning in chronic mtbi show minimal to no effect. Preliminary studies in OEF/OIF populations show small effect sizes. Assumption #2: In OEF/OIF populations, combat stress and psychological conditions are involved in the maintenance of symptom complaints Psychotherapeutic intervention is a necessary not adjunctive component of cognitive rehab for chronic mtbi

9 SCORE! Primary Outcome Measures Paced Auditory Serial Addition Test (PASAT) Symptom Checklist 90 (SCL-90) Total Score Subscales (anxiety; depression; somatization) Key Behaviors Change Inventory Inattention; Impulsivity; Apathy; Unawareness of problems Interpersonal Difficulties; Communication problems; Somatic Difficulties; Emotional Adjustment

10 SCORE! Secondary Outcome Measures Fatigue (Fatigue Severity Scale) Post-concussive symptoms (NSI) Quality of Life (WHO-QOL-BREF) Psychiatric (PCL-M; AUDIT) Headache severity (HIT-6) Locus of Control (MHLCS) Self-Efficacy (SEsx) Symptom Attribution Effort/Treatment Engagement (TOMM; RITS) Global NP composite (CVLT-2; TMT; Fluency; WAIS- IV PSI and WMI) Healthcare Utilization

11 SCORE! Arm 1 Psychoeducational Control Group Psychoeducational materials adapted for persistent post-concussive symptoms Routine follow-up (every three weeks) with medical staff Medical care (e.g., meds for depression) and referral for non-cognitive symptoms (e.g., vestibular rehab) All participants in all treatment arms receive these standard of care interventions consistent with VA/DoD Clinical Practice Guidelines for Management of Concussion/mTBI

12 TBI Step-Care Treatment Model COGNITIVE ISSUES IRRITABILITY / IMPULSIVITY SELF-CARE ROUTINES * (Sleep Hygiene) SOMATIC COMPLAINTS (Pain Management) BEHAVIORAL HEALTH ISSUES (Comorbidities) EDUCATION: Expectation of Recovery Begin each encounter at the bottom of the pyramid and progress upward * Includes Sleep Hygiene, diet, exercise, and avoiding further TBI Terrio 2009

13 SCORE! Arm 2 Non-Therapist Directed Computerized CR 10 hours of in-clinic, computerized treatment each week throughout the 6-week treatment trial (2 hrs/day Group (computer lab) format using laptops Proctored by RT and/or neuropsych tech. Proctor responsible for recording daily performance in AHLTA, providing positive reinforcement of participation and effort. Posit Science (empirically-validated in other clinical populations) chosen for this intervention. Uses both skill-specific training and general cognitive activation. Pre-determined course of therapy using novel content

14 Non-Traditional CR intervention Treatment Goal: Examine the effectiveness of a selfdirected, computerized intervention to reduce cognitive complaints. Proctor ensures only treatment engagement, not speed or mastery of content. Advantages of Approach Flexibility delivery of novel content focused primarily on auditory processing (self-paced) Scientifically-validated in other clinical populations Cost-effective Scalable Intervention consistent with culture of age-cohort

15 SCORE! Arm 3 Therapist-Directed Individualized CR 10 hours of individual and group treatment each week throughout the 6-week treatment trial. 5 hours per week of individual therapy (one hour sessions) 2 hours per week of group therapy 3 hours of weekly homework, to include computer work, such as APT-III. Encouragement and progress reports. All treatment completed by experienced therapists - SLP/OT

16 Traditional CR interventions Treatment Goal: Using both compensatory and restorative approaches, the traditional CR interventions have been designed specifically to address common cognitive complaints of Service Members with chronic mtbi. The Core Domains are addressed in Arms 3 & 4. Core Treatment Domains Goal Setting Prospective Memory & Assistive Technology Planning & Organization Sustained Attention Alternating Attention & Working Memory Memory & Learning

17 SCORE! Arm 4 Integrated Interdisciplinary CR 10 hours of individual and group treatment each week throughout the 6-week treatment trial. 4 hours per week of individual therapy (one hour sessions; 3 cognitive rehabilitation; 1 psychotherapy targeting anxiety/depressive symptoms) 3 hours per week of group therapy (2 cognitive rehabilitation and 1 group psychotherapy using CBT principles to target PCS and depression) 3 hours of weekly homework, to include 1 hour of psychotherapy homework; 2 hours of cognitive rehabilitation, including computer (e.g., APT-III).

18 Psychotherapeutic intervention Treatment Goal: Improved perception of cognitive functioning by addressing factors known to influence maintenance of post-concussive symptoms Individual Psychotherapy Traditional CBT approach situations/thoughts/feelings Relaxation training Defusion Techniques CBT approach to reduce the impact of distressing thoughts Group Psychotherapy Increased Self-Efficacy Symptom Re-Attribution Universality of Combat Improve Self-Care (e.g., improved sleep hygiene)

19 SCORE! Adverse Events Given the collaborative approach required for individuals to participate in Cognitive Rehabilitation, no significant adverse events are anticipated. Individuals who engage in cognitively demanding exercises may become overwhelmed or fatigued. Individuals with significant trauma exposure may experience psychological distress in individual and/or group psychotherapies. However, exposure therapy is not a component of this cognitive rehabilitation intervention.

20 SCORE! Reproducibility of Findings SCORE trial was designed from the outset with the goal of reproducibility Intervention Arm Limited to 6 weeks Manuals Developed for Arms 2, 3, 4 Therapist Lesson Plan Therapist Key Points Patient Handouts and Patient Homework Binder Worksheets included Therapist Fidelity Checklists Intent to Publish Manual(s) as part of Dissemination plan; Manuals in Public Domain

21 SCORE! Executive Committee Rodney Vanderploeg Amy Bowles Doug Cooper Lou French Jan Kennedy Loretta Polite Micaela Cornis-Pop Ricardo Amador Maren Cullen

22 SCORE! Treatment and Manual Development BAMC Traumatic Brain Injury Clinic Medical Staff Amy Bowles Michelle Lindsay OT/Recreational Therapy Chris Gillis Marina Leblanc Christy Muncrief Psychology/Neuropsychology Larry Perotti Jon Grizzle Doug Cooper Speech Language Pathology Kevin Manning Christine Fox Melissa Kolodziej

23 SCORE! Treatment and Manual Development Veterans Affairs and DVBIC DVBIC Jan Kennedy Rod Vanderploeg Renee Wilson Occupational Therapy Debbie Voydetich (Minneapolis VAMC) Speech Language Pathology Linda Picon (Tampa VAMC) Micaela Cornis-Pop (VA National) Don MacLennan (Minneapolis VAMC)

24 Questions?