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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
143
APT-III, Other standard individual and group interventions.
POSIT
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
Brooke Army Medical Center
San Antonio, Texas, United States
Emotional Functioning
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
Time frame: Baseline
Cognitive Efficiency
Paced Auditory Serial Addition Test (PASAT) * correct trial 1 * correct trial 2 * correct trial 3 * correct trial 4 Sum of trials 1-4
Time frame: Baseline
Functional Behaviors
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
Time frame: Baseline
Emotional Functioning
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
Time frame: 3 Weeks
Emotional Functioning
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
Time frame: 6 Weeks
Emotional Functioning
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
Time frame: 12 Weeks
Emotional Functioning
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
Time frame: 18 Weeks
Cognitive Efficiency
Paced Auditory Serial Addition Test (PASAT) * correct trial 1 * correct trial 2 * correct trial 3 * correct trial 4 Sum of trials 1-4
Time frame: 3 Weeks
Cognitive Efficiency
Paced Auditory Serial Addition Test (PASAT) * correct trial 1 * correct trial 2 * correct trial 3 * correct trial 4 Sum of trials 1-4
Time frame: 6 Weeks
Cognitive Efficiency
Paced Auditory Serial Addition Test (PASAT) * correct trial 1 * correct trial 2 * correct trial 3 * correct trial 4 Sum of trials 1-4
Time frame: 12 Weeks
Cognitive Efficiency
Paced Auditory Serial Addition Test (PASAT) * correct trial 1 * correct trial 2 * correct trial 3 * correct trial 4 Sum of trials 1-4
Time frame: 18 Weeks
Functional Behaviors
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
Time frame: 3 Weeks
Functional Behaviors
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
Time frame: 6 Weeks
Functional Behaviors
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
Time frame: 12 Weeks
Functional Behaviors
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
Time frame: 18 Weeks
Fatigue
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
Time frame: Baseline
Post-Concussive Symptoms
Neurobehavioral Symptom Inventory Total Raw scale 22 individual items
Time frame: Baseline
Self Reported Quality of Life
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
Time frame: Baseline
Neuropsychological Status
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
Time frame: Baseline
Self Reported Alcohol Use Behaviors
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
Time frame: Baseline
Post-Traumatic Stress Symptomatology
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
Time frame: 18 Weeks
Self Reported Headache Disability
Headache Impact Test-6 (HIT-6) Total Weighted Score
Time frame: Baseline
Health Related (Cognition) Locus of Control
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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
Time frame: Baseline
Perceived Self-Efficacy (Cognition)
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
Time frame: Baseline
Attribution of Cognitive Symptoms
Cognitive Symptom Attribution Scale 7 individual items
Time frame: Baseline
Therapist-Rated Patient Engagement in Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Time frame: Week 6 of treatment
Post-Concussive Symptoms
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
Time frame: 6 Weeks
Post-Concussive Symptoms
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
Time frame: 12 weeks
Post-Concussive Symptoms
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
Time frame: 18 weeks
Fatigue
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
Time frame: 6 weeks
Fatigue
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
Time frame: 12 Weeks
Fatigue
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
Time frame: 18 Weeks
Change in Healthcare Utilization
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.
Time frame: 30 days prior to Baseline and 6 months post Baseline
Self Reported Quality of Life
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
Time frame: 6 weeks
Self Reported Quality of Life
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
Time frame: 12 weeks
Self Reported Quality of Life
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
Time frame: 18 weeks
Neuropsychological Status
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
Time frame: 6 Weeks
Neuropsychological Status
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
Time frame: 12 Weeks
Neuropsychological Status
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
Time frame: 18 Weeks
Self Reported Alcohol Use Behaviors
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
Time frame: 6 weeks
Self Reported Alcohol Use Behaviors
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
Time frame: 12 weeks
Self Reported Alcohol Use Behaviors
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
Time frame: 18 weeks
Post-Traumatic Stress Symptomatology
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
Time frame: 6 weeks
Post-Traumatic Stress Symptomatology
Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items
Time frame: Baseline
Post-Traumatic Stress Symptomatology
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
Time frame: 12 Weeks
Self Reported Headache Disability
Headache Impact Test-6 (HIT-6) Total Weighted Score
Time frame: 6 weeks
Self Reported Headache Disability
Headache Impact Test-6 (HIT-6) Total Weighted Score
Time frame: 12 weeks
Self Reported Headache Disability
Headache Impact Test-6 (HIT-6) Total Weighted Score
Time frame: 18 Weeks
Health Related (Cognition) Locus of Control
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
Time frame: 6 weeks
Health Related (Cognition) Locus of Control
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
Time frame: 12 weeks
Health Related (Cognition) Locus of Control
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
Time frame: 18 weeks
Perceived Self-Efficacy (Cognition)
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
Time frame: 6 weeks
Perceived Self-Efficacy (Cognition)
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
Time frame: 12 weeks
Perceived Self-Efficacy (Cognition)
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
Time frame: 18 weeks
Attribution of Cognitive Symptoms
Cognitive Symptom Attribution Scale 7 individual items
Time frame: 6 weeks
Attribution of Cognitive Symptoms
Cognitive Symptom Attribution Scale 7 individual items
Time frame: 12 weeks
Attribution of Cognitive Symptoms
Cognitive Symptom Attribution Scale 7 individual items
Time frame: 18 weeks
Therapist-Rated Patient Engagement in Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Time frame: Week 1 of Treatment
Therapist-Rated Patient Engagement in Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Time frame: Week 2 of treatment
Therapist-Rated Patient Engagement in Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Time frame: Week 3 of treatment
Therapist-Rated Patient Engagement in Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Time frame: Week 4 of treatment
Therapist-Rated Patient Engagement in Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Time frame: Week 5 of treatment