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The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury (SCORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01339806
Recruitment Status : Completed
First Posted : April 21, 2011
Last Update Posted : February 9, 2015
Sponsor:
Collaborators:
The Defense and Veterans Brain Injury Center
Henry M. Jackson Foundation for the Advancement of Military Medicine
Information provided by (Responsible Party):
Amy Bowles, M.D., Brooke Army Medical Center

April 15, 2011
April 21, 2011
February 9, 2015
June 2011
June 2014   (Final data collection date for primary outcome measure)
  • Emotional Functioning [ Time Frame: Baseline ]

    Symptom Checklist-90-Revised (SCL-90-R)

    Global Severity Index and 9 subscales:

    Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism

  • Cognitive Efficiency [ Time Frame: Baseline ]

    Paced Auditory Serial Addition Test (PASAT)

    • correct trial 1
    • correct trial 2
    • correct trial 3
    • correct trial 4 Sum of trials 1-4
  • Functional Behaviors [ Time Frame: Baseline ]
    Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
  • Emotional Functioning [ Time Frame: 3 Weeks ]

    Symptom Checklist-90-Revised (SCL-90-R)

    Global Severity Index and 9 subscales:

    Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism

  • Emotional Functioning [ Time Frame: 6 Weeks ]

    Symptom Checklist-90-Revised (SCL-90-R)

    Global Severity Index and 9 subscales:

    Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism

  • Emotional Functioning [ Time Frame: 12 Weeks ]

    Symptom Checklist-90-Revised (SCL-90-R)

    Global Severity Index and 9 subscales:

    Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism

  • Emotional Functioning [ Time Frame: 18 Weeks ]

    Symptom Checklist-90-Revised (SCL-90-R)

    Global Severity Index and 9 subscales:

    Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism

  • Cognitive Efficiency [ Time Frame: 3 Weeks ]

    Paced Auditory Serial Addition Test (PASAT)

    • correct trial 1
    • correct trial 2
    • correct trial 3
    • correct trial 4 Sum of trials 1-4
  • Cognitive Efficiency [ Time Frame: 6 Weeks ]

    Paced Auditory Serial Addition Test (PASAT)

    • correct trial 1
    • correct trial 2
    • correct trial 3
    • correct trial 4 Sum of trials 1-4
  • Cognitive Efficiency [ Time Frame: 12 Weeks ]

    Paced Auditory Serial Addition Test (PASAT)

    • correct trial 1
    • correct trial 2
    • correct trial 3
    • correct trial 4 Sum of trials 1-4
  • Cognitive Efficiency [ Time Frame: 18 Weeks ]

    Paced Auditory Serial Addition Test (PASAT)

    • correct trial 1
    • correct trial 2
    • correct trial 3
    • correct trial 4 Sum of trials 1-4
  • Functional Behaviors [ Time Frame: 3 Weeks ]
    Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
  • Functional Behaviors [ Time Frame: 6 Weeks ]
    Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
  • Functional Behaviors [ Time Frame: 12 Weeks ]
    Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
  • Functional Behaviors [ Time Frame: 18 Weeks ]
    Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
Same as current
Complete list of historical versions of study NCT01339806 on ClinicalTrials.gov Archive Site
  • Fatigue [ Time Frame: Baseline ]
    Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
  • Post-Concussive Symptoms [ Time Frame: Baseline ]
    Neurobehavioral Symptom Inventory Total Raw scale 22 individual items
  • Self Reported Quality of Life [ Time Frame: Baseline ]

    World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

    Total score for each of the 5 subscale domains:

    Overall Functioning Physical Capacity Psychological Social Relationships Environment

  • Neuropsychological Status [ Time Frame: Baseline ]
    Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
  • Self Reported Alcohol Use Behaviors [ Time Frame: Baseline ]
    Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
  • Post-Traumatic Stress Symptomatology [ Time Frame: 18 Weeks ]
    Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
  • Self Reported Headache Disability [ Time Frame: Baseline ]
    Headache Impact Test-6 (HIT-6) Total Weighted Score
  • Health Related (Cognition) Locus of Control [ Time Frame: Baseline ]
    Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
  • Perceived Self-Efficacy (Cognition) [ Time Frame: Baseline ]
    Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
  • Attribution of Cognitive Symptoms [ Time Frame: Baseline ]
    Cognitive Symptom Attribution Scale 7 individual items
  • Therapist-Rated Patient Engagement in Treatment [ Time Frame: Week 6 of treatment ]
    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
  • Post-Concussive Symptoms [ Time Frame: 6 Weeks ]
    Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
  • Post-Concussive Symptoms [ Time Frame: 12 weeks ]
    Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
  • Post-Concussive Symptoms [ Time Frame: 18 weeks ]
    Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
  • Fatigue [ Time Frame: 6 weeks ]
    Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
  • Fatigue [ Time Frame: 12 Weeks ]
    Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
  • Fatigue [ Time Frame: 18 Weeks ]
    Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
  • Change in Healthcare Utilization [ Time Frame: 30 days prior to Baseline and 6 months post Baseline ]
    Summed total number of appointments 30 days prior to study enrollment and summed total number of appointments for 30 days between 5 and 6 months post-treatment.
  • Self Reported Quality of Life [ Time Frame: 6 weeks ]

    World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

    Total score for each of the 5 subscale domains:

    Overall Functioning Physical Capacity Psychological Social Relationships Environment

  • Self Reported Quality of Life [ Time Frame: 12 weeks ]

    World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

    Total score for each of the 5 subscale domains:

    Overall Functioning Physical Capacity Psychological Social Relationships Environment

  • Self Reported Quality of Life [ Time Frame: 18 weeks ]

    World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

    Total score for each of the 5 subscale domains:

    Overall Functioning Physical Capacity Psychological Social Relationships Environment

  • Neuropsychological Status [ Time Frame: 6 Weeks ]
    Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
  • Neuropsychological Status [ Time Frame: 12 Weeks ]
    Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
  • Neuropsychological Status [ Time Frame: 18 Weeks ]
    Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
  • Self Reported Alcohol Use Behaviors [ Time Frame: 6 weeks ]
    Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
  • Self Reported Alcohol Use Behaviors [ Time Frame: 12 weeks ]
    Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
  • Self Reported Alcohol Use Behaviors [ Time Frame: 18 weeks ]
    Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
  • Post-Traumatic Stress Symptomatology [ Time Frame: 6 weeks ]
    Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
  • Post-Traumatic Stress Symptomatology [ Time Frame: Baseline ]
    Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items
  • Post-Traumatic Stress Symptomatology [ Time Frame: 12 Weeks ]
    Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
  • Self Reported Headache Disability [ Time Frame: 6 weeks ]
    Headache Impact Test-6 (HIT-6) Total Weighted Score
  • Self Reported Headache Disability [ Time Frame: 12 weeks ]
    Headache Impact Test-6 (HIT-6) Total Weighted Score
  • Self Reported Headache Disability [ Time Frame: 18 Weeks ]
    Headache Impact Test-6 (HIT-6) Total Weighted Score
  • Health Related (Cognition) Locus of Control [ Time Frame: 6 weeks ]
    Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
  • Health Related (Cognition) Locus of Control [ Time Frame: 12 weeks ]
    Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
  • Health Related (Cognition) Locus of Control [ Time Frame: 18 weeks ]
    Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
  • Perceived Self-Efficacy (Cognition) [ Time Frame: 6 weeks ]
    Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
  • Perceived Self-Efficacy (Cognition) [ Time Frame: 12 weeks ]
    Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
  • Perceived Self-Efficacy (Cognition) [ Time Frame: 18 weeks ]
    Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
  • Attribution of Cognitive Symptoms [ Time Frame: 6 weeks ]
    Cognitive Symptom Attribution Scale 7 individual items
  • Attribution of Cognitive Symptoms [ Time Frame: 12 weeks ]
    Cognitive Symptom Attribution Scale 7 individual items
  • Attribution of Cognitive Symptoms [ Time Frame: 18 weeks ]
    Cognitive Symptom Attribution Scale 7 individual items
  • Therapist-Rated Patient Engagement in Treatment [ Time Frame: Week 1 of Treatment ]
    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
  • Therapist-Rated Patient Engagement in Treatment [ Time Frame: Week 2 of treatment ]
    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
  • Therapist-Rated Patient Engagement in Treatment [ Time Frame: Week 3 of treatment ]
    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
  • Therapist-Rated Patient Engagement in Treatment [ Time Frame: Week 4 of treatment ]
    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
  • Therapist-Rated Patient Engagement in Treatment [ Time Frame: Week 5 of treatment ]
    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
  • Fatigue [ Time Frame: Baseline ]
    Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
  • Post-Concussive Symptoms [ Time Frame: Baseline ]
    Neurobehavioral Symptom Inventory Total Raw scale 22 individual items
  • Self Reported Quality of Life [ Time Frame: Baseline ]

    World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

    Total score for each of the 5 subscale domains:

    Overall Functioning Physical Capacity Psychological Social Relationships Environment

  • Neuropsychological Status [ Time Frame: Baseline ]
    Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
  • Self Reported Alcohol Use Behaviors [ Time Frame: Baseline ]
    Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
  • Post-Traumatic Stress Symptomatology [ Time Frame: 18 Weeks ]
    Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items
  • Self Reported Headache Disability [ Time Frame: Baseline ]
    Headache Impact Test-6 (HIT-6) Total Weighted Score
  • Health Related (Cognition) Locus of Control [ Time Frame: Baseline ]
    Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
  • Perceived Self-Efficacy (Cognition) [ Time Frame: Baseline ]
    Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
  • Attribution of Cognitive Symptoms [ Time Frame: Baseline ]
    Cognitive Symptom Attribution Scale 7 individual items
  • Therapist-Rated Patient Engagement in Treatment [ Time Frame: Week 6 of treatment ]
    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
  • Post-Concussive Symptoms [ Time Frame: 6 Weeks ]
    Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
  • Post-Concussive Symptoms [ Time Frame: 12 weeks ]
    Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
  • Post-Concussive Symptoms [ Time Frame: 18 weeks ]
    Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
  • Fatigue [ Time Frame: 6 weeks ]
    Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
  • Fatigue [ Time Frame: 12 Weeks ]
    Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
  • Fatigue [ Time Frame: 18 Weeks ]
    Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
  • Change in Healthcare Utilization [ Time Frame: 30 days prior to Baseline and 6 months post Baseline ]
    Summed total number of appointments 30 days prior to study enrollment and summed total number of appointments for 30 days between 5 and 6 months post-treatment.
  • Self Reported Quality of Life [ Time Frame: 6 weeks ]

    World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

    Total score for each of the 5 subscale domains:

    Overall Functioning Physical Capacity Psychological Social Relationships Environment

  • Self Reported Quality of Life [ Time Frame: 12 weeks ]

    World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

    Total score for each of the 5 subscale domains:

    Overall Functioning Physical Capacity Psychological Social Relationships Environment

  • Self Reported Quality of Life [ Time Frame: 18 weeks ]

    World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

    Total score for each of the 5 subscale domains:

    Overall Functioning Physical Capacity Psychological Social Relationships Environment

  • Neuropsychological Status [ Time Frame: 6 Weeks ]
    Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
  • Neuropsychological Status [ Time Frame: 12 Weeks ]
    Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
  • Neuropsychological Status [ Time Frame: 18 Weeks ]
    Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
  • Self Reported Alcohol Use Behaviors [ Time Frame: 6 weeks ]
    Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
  • Self Reported Alcohol Use Behaviors [ Time Frame: 12 weeks ]
    Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
  • Self Reported Alcohol Use Behaviors [ Time Frame: 18 weeks ]
    Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
  • Post-Traumatic Stress Symptomatology [ Time Frame: 6 weeks ]
    Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items
  • Post-Traumatic Stress Symptomatology [ Time Frame: Baseline ]
    Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items
  • Post-Traumatic Stress Symptomatology [ Time Frame: 12 Weeks ]
    Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items
  • Self Reported Headache Disability [ Time Frame: 6 weeks ]
    Headache Impact Test-6 (HIT-6) Total Weighted Score
  • Self Reported Headache Disability [ Time Frame: 12 weeks ]
    Headache Impact Test-6 (HIT-6) Total Weighted Score
  • Self Reported Headache Disability [ Time Frame: 18 Weeks ]
    Headache Impact Test-6 (HIT-6) Total Weighted Score
  • Health Related (Cognition) Locus of Control [ Time Frame: 6 weeks ]
    Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
  • Health Related (Cognition) Locus of Control [ Time Frame: 12 weeks ]
    Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
  • Health Related (Cognition) Locus of Control [ Time Frame: 18 weeks ]
    Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
  • Perceived Self-Efficacy (Cognition) [ Time Frame: 6 weeks ]
    Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
  • Perceived Self-Efficacy (Cognition) [ Time Frame: 12 weeks ]
    Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
  • Perceived Self-Efficacy (Cognition) [ Time Frame: 18 weeks ]
    Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
  • Attribution of Cognitive Symptoms [ Time Frame: 6 weeks ]
    Cognitive Symptom Attribution Scale 7 individual items
  • Attribution of Cognitive Symptoms [ Time Frame: 12 weeks ]
    Cognitive Symptom Attribution Scale 7 individual items
  • Attribution of Cognitive Symptoms [ Time Frame: 18 weeks ]
    Cognitive Symptom Attribution Scale 7 individual items
  • Therapist-Rated Patient Engagement in Treatment [ Time Frame: Week 1 of Treatment ]
    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
  • Therapist-Rated Patient Engagement in Treatment [ Time Frame: Week 2 of treatment ]
    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
  • Therapist-Rated Patient Engagement in Treatment [ Time Frame: Week 3 of treatment ]
    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
  • Therapist-Rated Patient Engagement in Treatment [ Time Frame: Week 4 of treatment ]
    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
  • Therapist-Rated Patient Engagement in Treatment [ Time Frame: Week 5 of treatment ]
    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Not Provided
Not Provided
 
The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury
Phase IV Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury
The objective of this trial is to evaluate the effectiveness of cognitive rehabilitation in OIF/OEF service members with a history of mild traumatic brain injury and persistent (3-24 months post injury) cognitive complaints. This is a prospective, randomized, control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study. Subjects will be evaluated prior to the start of treatment and 3, 6, 12, and 18 weeks following the initiation of the study. The total number of patients to be studied is 160 (maximum), which is approximately 20 patients per month.

This is a prospective, randomized, control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study: 1. Psychoeducational control group; 2. Non-therapist directed, computerized cognitive rehabilitation; 3. Therapist-directed individualized cognitive rehabilitation; and 4. Integrated interdisciplinary cognitive rehabilitation combined with cognitive-behavioral psychotherapy. (Components of the treatment arms are described in detail in section 4.6; Research Design and Methods.) All subjects enrolled in the study will receive the standard of care in management of chronic post-concussive symptoms, consistent with the VA/DoD Clinical Practice Guidelines for the Management of Concussion/mild TBI (Barth et al., 2009), regardless of treatment assignment. The standard of care includes provision of patient education materials (adapted from existing studies to address more persistent rather than acute symptom management), regular scheduled follow-up with a medical provider every three weeks, and symptom-based treatment of post-concussive complaints (e.g., medication trials for headache and co-occurring psychiatric disorders, physical therapy for vestibular complaints, case management, and supportive counseling with social work for soldiers assigned to the Warriors-in-Transition Battalion). Study participants who are assigned to treatment arms 2, 3, or 4 will additionally receive manualized cognitive rehabilitation therapies during the 6-week treatment phase of the study. Cognitive rehabilitation treatment intensity (i.e., number of hours of treatment per week) will be matched for individuals assigned to treatment arms 2, 3, or 4. Participants assigned to the control treatment group (treatment arm 1) will be offered individualized cognitive rehabilitation therapy if their cognitive complaints do not abate following the completion of the six-week treatment trial.

Study participants will be evaluated prior to the initiation of treatment, as well as at 3-weeks, 6-weeks, 12-weeks, and 18-weeks following the start of treatment. Study evaluators will be blind to treatment assignment. Pre-treatment baseline assessments and peri-/post-treatment outcome assessments will include demographic information, injury-related variables, self-report inventories, performance on neuropsychological testing, and functional status (e.g., work status; healthcare utilization). Detailed descriptions of the data to be collected including primary and secondary outcome measures, as well as co-variate measures can be found in section 4.8: Instrumentation.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Traumatic Brain Injury With Brief Loss of Consciousness
  • Traumatic Brain Injury With No Loss of Consciousness
  • Behavioral: Cognitive Rehab
    APT-III, Other standard individual and group interventions.
    Other Name: APT-III
  • Behavioral: Brainworks
    POSIT
    Other Name: POSIT
  • Behavioral: Informational Handout/Provider Visits
    Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
  • Standard of Care for mTBI Provider Arm
    Arm 1: Psychoeducational Control Group. Individuals assigned to arm 1 will receive psychoeducational materials specifically adapted for persistent management of symptoms and routine follow-up with medical providers (every three weeks). Additionally, subjects assigned to this group will receive medical care (e.g., psychopharmacological management of depression) and/or referral for symptom management (e.g., vestibular rehabilitation) of non-cognitive complaints, consistent with the current standard of care treatment model for managing post-concussive symptoms (see Figure below adapted with permission from authors; Brenner et al., 2009).
    Intervention: Behavioral: Informational Handout/Provider Visits
  • Experimental: Computer Based Therapy Group
    Arm 2: Non-therapist directed computerized cognitive rehabilitation. Individuals assigned to treatment arm 2 will receive ten hours of in-clinic, computerized treatment per week throughout the 6-week treatment trial. Participants will be scheduled for 2 hours per day, proctored by clinic staff (certified recreation therapist or neuropsychology technician) who will be responsible for recording daily performance, providing positive reinforcement of participation, and effort. Computer programs selected for this treatment trial include both skill-specific training (e.g., attention processes) and general cognitive activation. These computer programs are commercially available and advertised as "brain fitness" or "brain training."
    Interventions:
    • Behavioral: Brainworks
    • Behavioral: Informational Handout/Provider Visits
  • Experimental: Cognitive Rehab Group
    Arm 3: Therapist-directed individualized cognitive rehabilitation. Individuals assigned to treatment arm 3 will receive 10 hours of individual and group cognitive rehabilitation treatment (including homework assignments) per week conducted by credentialed speech therapists and occupational therapists. The treatment components will include five hours of weekly individual therapy (one-hour sessions; two hours focused on compensatory strategies and three hours focused on restorative strategies), two hours of weekly group therapy (one hour sessions focused on compensatory strategies), and three hours of weekly computer-based "homework" proctored by clinic staff who will be responsible for recording performance, and providing positive reinforcement of participation and effort.
    Interventions:
    • Behavioral: Cognitive Rehab
    • Behavioral: Informational Handout/Provider Visits
  • Experimental: Cognitive and Psychological Based Rehab
    Arm 4: Integrated interdisciplinary cognitive rehabilitation combined with cognitive-behavioral psychotherapy. Individuals assigned to treatment arm 4 will receive 10 hours of individual and group treatment per week conducted by credentialed therapists and doctoral-level psychologists. The treatment components will include four hours of weekly 1 hr individual therapy sessions; 2 hrs of cognitive rehabilitation, 1 hr of cognitive rehab & 1 hr of individual psychotherapy targeting anxiety/combat stress symptoms including relaxation training & exposure therapy and cognitive-behavioral principles, 3 hrs of weekly group therapy & three hours of weekly "homework" including 30-mins relaxation training, 30-mins cognitive-behavioral psychotherapy homework, and 2 hrs of computerized cognitive rehabilitation exercises proctored by clinic staff.
    Interventions:
    • Behavioral: Cognitive Rehab
    • Behavioral: Informational Handout/Provider Visits
Vanderploeg RD, Cooper DB, Curtiss G, Kennedy JE, Tate DF, Bowles AO. Predicting treatment response to cognitive rehabilitation in military service members with mild traumatic brain injury. Rehabil Psychol. 2018 May;63(2):194-204. doi: 10.1037/rep0000215.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
143
160
August 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of mTBI as defined in the VA/DoD Clinical Practice Guidelines for the Management of Concussion/mild TBI (Barth et al., 2009) which occurred during deployment in support of OEF/OIF within 3-24 months of study enrollment;
  • Presence of cognitive complaints (NSI score of 3 or higher on any of the four cognitive symptoms)
  • Ability to understand and communicate in English.

Exclusion Criteria:

  • Medical/psychiatric/neurologic co-morbidities of: blindness/low vision; uncontrolled seizure disorder; psychosis; history of moderate, severe TBI or penetrating BI; or Spinal Cord Injury with no use of upper extremities;
  • Active participation in intensive (> 5 appointments per week) treatment for amputation, orthopedic trauma, burns, substance abuse, or post-traumatic stress disorder which would preclude full participation in an intensive cognitive rehabilitation program; or
  • Daily use of narcotic pain medication(s).
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01339806
C.2010.199
Yes
Not Provided
Not Provided
Amy Bowles, M.D., Brooke Army Medical Center
Brooke Army Medical Center
  • The Defense and Veterans Brain Injury Center
  • Henry M. Jackson Foundation for the Advancement of Military Medicine
Principal Investigator: Amy O Bowles, MD BAMC
Brooke Army Medical Center
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP