The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury

Traumatic Brain Injury With Brief Loss of Consciousness Clinical Trial

— SCORE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339806
• Other study ID #: C.2010.199
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2011
• Last updated: February 6, 2015
• Start date: June 2011
• Est. completion date: August 2014

Study information

• Verified date: February 2015
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Traumatic Brain Injury With Brief Loss of Consciousness
• Traumatic Brain Injury With No Loss of Consciousness
• Unconsciousness

Intervention

Behavioral:
• Cognitive Rehab
APT-III, Other standard individual and group interventions.
• Brainworks
POSIT
• Informational Handout/Provider Visits
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Brooke Army Medical Center	Henry M. Jackson Foundation for the Advancement of Military Medicine, The Defense and Veterans Brain Injury Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline	No
Primary	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	Baseline	No
Primary	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	Baseline	No
Primary	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	3 Weeks	No
Primary	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	6 Weeks	No
Primary	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	12 Weeks	No
Primary	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	18 Weeks	No
Primary	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	3 Weeks	No
Primary	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	6 Weeks	No
Primary	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	12 Weeks	No
Primary	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	18 Weeks	No
Primary	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	3 Weeks	No
Primary	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	6 Weeks	No
Primary	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	12 Weeks	No
Primary	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	18 Weeks	No
Secondary	Fatigue	Fatigue Severity Scale (FSS) Total Raw scale 9 individual items	Baseline	No
Secondary	Post-Concussive Symptoms	Neurobehavioral Symptom Inventory Total Raw scale 22 individual items	Baseline	No
Secondary	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	Baseline	No
Secondary	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	Baseline	No
Secondary	Self Reported Alcohol Use Behaviors	Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items	Baseline	No
Secondary	Post-Traumatic Stress Symptomatology	Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items	18 Weeks	No
Secondary	Self Reported Headache Disability	Headache Impact Test-6 (HIT-6) Total Weighted Score	Baseline	No
Secondary	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	Baseline	No
Secondary	Perceived Self-Efficacy (Cognition)	Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items	Baseline	No
Secondary	Attribution of Cognitive Symptoms	Cognitive Symptom Attribution Scale 7 individual items	Baseline	No
Secondary	Therapist-Rated Patient Engagement in Treatment	Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)	Week 6 of treatment	No
Secondary	Post-Concussive Symptoms	Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items	6 Weeks	No
Secondary	Post-Concussive Symptoms	Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items	12 weeks	No
Secondary	Post-Concussive Symptoms	Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items	18 weeks	No
Secondary	Fatigue	Fatigue Severity Scale (FSS) Total Raw scale 9 individual items	6 weeks	No
Secondary	Fatigue	Fatigue Severity Scale (FSS) Total Raw scale 9 individual items	12 Weeks	No
Secondary	Fatigue	Fatigue Severity Scale (FSS) Total Raw scale 9 individual items	18 Weeks	No
Secondary	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.	30 days prior to Baseline and 6 months post Baseline	No
Secondary	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	6 weeks	No
Secondary	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	12 weeks	No
Secondary	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	18 weeks	No
Secondary	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	6 Weeks	No
Secondary	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	12 Weeks	No
Secondary	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	18 Weeks	No
Secondary	Self Reported Alcohol Use Behaviors	Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items	6 weeks	No
Secondary	Self Reported Alcohol Use Behaviors	Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items	12 weeks	No
Secondary	Self Reported Alcohol Use Behaviors	Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items	18 weeks	No
Secondary	Post-Traumatic Stress Symptomatology	Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items	6 weeks	No
Secondary	Post-Traumatic Stress Symptomatology	Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items	Baseline	No
Secondary	Post-Traumatic Stress Symptomatology	Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items	12 Weeks	No
Secondary	Self Reported Headache Disability	Headache Impact Test-6 (HIT-6) Total Weighted Score	6 weeks	No
Secondary	Self Reported Headache Disability	Headache Impact Test-6 (HIT-6) Total Weighted Score	12 weeks	No
Secondary	Self Reported Headache Disability	Headache Impact Test-6 (HIT-6) Total Weighted Score	18 Weeks	No
Secondary	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	6 weeks	No
Secondary	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	12 weeks	No
Secondary	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	18 weeks	No
Secondary	Perceived Self-Efficacy (Cognition)	Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items	6 weeks	No
Secondary	Perceived Self-Efficacy (Cognition)	Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items	12 weeks	No
Secondary	Perceived Self-Efficacy (Cognition)	Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items	18 weeks	No
Secondary	Attribution of Cognitive Symptoms	Cognitive Symptom Attribution Scale 7 individual items	6 weeks	No
Secondary	Attribution of Cognitive Symptoms	Cognitive Symptom Attribution Scale 7 individual items	12 weeks	No
Secondary	Attribution of Cognitive Symptoms	Cognitive Symptom Attribution Scale 7 individual items	18 weeks	No
Secondary	Therapist-Rated Patient Engagement in Treatment	Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)	Week 1 of Treatment	No
Secondary	Therapist-Rated Patient Engagement in Treatment	Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)	Week 2 of treatment	No
Secondary	Therapist-Rated Patient Engagement in Treatment	Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)	Week 3 of treatment	No
Secondary	Therapist-Rated Patient Engagement in Treatment	Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)	Week 4 of treatment	No
Secondary	Therapist-Rated Patient Engagement in Treatment	Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)	Week 5 of treatment	No

External Links

•   Defense and Veterans Brain Injury Center
•   San Antonio Military Medical Center