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Completed

NCT Number: NCT01339806

The 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.

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Key information

Conditions

Traumatic Brain Injury With Brief Loss of Consciousness Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Traumatic Brain Injury With No Loss of Consciousness Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cognitive Rehab

Behavioral

APT-III, Other standard individual and group interventions.

Other names: APT-III

BrainWorks

Behavioral

POSIT

Other names: POSIT

Informational Handout/Provider Visits

Behavioral

Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

Secondary outcomes

  1. Fatigue

    Time frame: Baseline

    Fatigue Severity Scale (FSS) Total Raw scale 9 individual items

  2. Post-Concussive Symptoms

    Time frame: Baseline

    Neurobehavioral Symptom Inventory Total Raw scale 22 individual items

  3. 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

  4. 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

  5. Self Reported Alcohol Use Behaviors

    Time frame: Baseline

    Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items

  6. Post-Traumatic Stress Symptomatology

    Time frame: 18 Weeks

    Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items

  7. Self Reported Headache Disability

    Time frame: Baseline

    Headache Impact Test-6 (HIT-6) Total Weighted Score

  8. 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

  9. Perceived Self-Efficacy (Cognition)

    Time frame: Baseline

    Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items

  10. Attribution of Cognitive Symptoms

    Time frame: Baseline

    Cognitive Symptom Attribution Scale 7 individual items

  11. Therapist-Rated Patient Engagement in Treatment

    Time frame: Week 6 of treatment

    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)

  12. Post-Concussive Symptoms

    Time frame: 6 Weeks

    Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items

  13. Post-Concussive Symptoms

    Time frame: 12 weeks

    Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items

  14. Post-Concussive Symptoms

    Time frame: 18 weeks

    Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items

  15. Fatigue

    Time frame: 6 weeks

    Fatigue Severity Scale (FSS) Total Raw scale 9 individual items

  16. Fatigue

    Time frame: 12 Weeks

    Fatigue Severity Scale (FSS) Total Raw scale 9 individual items

  17. Fatigue

    Time frame: 18 Weeks

    Fatigue Severity Scale (FSS) Total Raw scale 9 individual items

  18. 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.

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. Self Reported Alcohol Use Behaviors

    Time frame: 6 weeks

    Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items

  26. Self Reported Alcohol Use Behaviors

    Time frame: 12 weeks

    Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items

  27. Self Reported Alcohol Use Behaviors

    Time frame: 18 weeks

    Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items

  28. Post-Traumatic Stress Symptomatology

    Time frame: 6 weeks

    Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items

  29. Post-Traumatic Stress Symptomatology

    Time frame: Baseline

    Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items

  30. Post-Traumatic Stress Symptomatology

    Time frame: 12 Weeks

    Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items

  31. Self Reported Headache Disability

    Time frame: 6 weeks

    Headache Impact Test-6 (HIT-6) Total Weighted Score

  32. Self Reported Headache Disability

    Time frame: 12 weeks

    Headache Impact Test-6 (HIT-6) Total Weighted Score

  33. Self Reported Headache Disability

    Time frame: 18 Weeks

    Headache Impact Test-6 (HIT-6) Total Weighted Score

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. Attribution of Cognitive Symptoms

    Time frame: 6 weeks

    Cognitive Symptom Attribution Scale 7 individual items

  41. Attribution of Cognitive Symptoms

    Time frame: 12 weeks

    Cognitive Symptom Attribution Scale 7 individual items

  42. Attribution of Cognitive Symptoms

    Time frame: 18 weeks

    Cognitive Symptom Attribution Scale 7 individual items

  43. Therapist-Rated Patient Engagement in Treatment

    Time frame: Week 1 of Treatment

    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)

  44. Therapist-Rated Patient Engagement in Treatment

    Time frame: Week 2 of treatment

    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)

  45. Therapist-Rated Patient Engagement in Treatment

    Time frame: Week 3 of treatment

    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)

  46. Therapist-Rated Patient Engagement in Treatment

    Time frame: Week 4 of treatment

    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)

  47. Therapist-Rated Patient Engagement in Treatment

    Time frame: Week 5 of treatment

    Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Collaborators

  • Henry M. Jackson Foundation for the Advancement of Military Medicine
  • The Defense and Veterans Brain Injury Center

Registry information

Official study title

Phase IV Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury

Acronym: SCORE

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 21, 2011
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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