Clinical trial NCT01339806: The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury
Official title: Phase IV Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Traumatic Brain Injury With Brief Loss of Consciousness
Traumatic Brain Injury With No Loss of Consciousness
Keywords: mTBI
Concussion
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: The Defense and Veterans Brain Injury Center
name: Henry M. Jackson Foundation for the Advancement of Military Medicine
First posted: 2011-04-21
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Emotional Functioning
timeFrame: Baseline
measure: Cognitive Efficiency
timeFrame: Baseline
measure: Functional Behaviors
timeFrame: Baseline
measure: Emotional Functioning
timeFrame: 3 Weeks
measure: Emotional Functioning
timeFrame: 6 Weeks
measure: Emotional Functioning
timeFrame: 12 Weeks
measure: Emotional Functioning
timeFrame: 18 Weeks
measure: Cognitive Efficiency
timeFrame: 3 Weeks
measure: Cognitive Efficiency
timeFrame: 6 Weeks
measure: Cognitive Efficiency
timeFrame: 12 Weeks
measure: Cognitive Efficiency
timeFrame: 18 Weeks
measure: Functional Behaviors
timeFrame: 3 Weeks
measure: Functional Behaviors
timeFrame: 6 Weeks
measure: Functional Behaviors
timeFrame: 12 Weeks
measure: Functional Behaviors
timeFrame: 18 Weeks
Secondary outcomes:
measure: Fatigue
timeFrame: Baseline
measure: Post-Concussive Symptoms
timeFrame: Baseline
measure: Self Reported Quality of Life
timeFrame: Baseline
measure: Neuropsychological Status
timeFrame: Baseline
measure: Self Reported Alcohol Use Behaviors
timeFrame: Baseline
measure: Post-Traumatic Stress Symptomatology
timeFrame: 18 Weeks
measure: Self Reported Headache Disability
timeFrame: Baseline
measure: Health Related (Cognition) Locus of Control
timeFrame: Baseline
measure: Perceived Self-Efficacy (Cognition)
timeFrame: Baseline
measure: Attribution of Cognitive Symptoms
timeFrame: Baseline
measure: Therapist-Rated Patient Engagement in Treatment
timeFrame: Week 6 of treatment
measure: Post-Concussive Symptoms
timeFrame: 6 Weeks
measure: Post-Concussive Symptoms
timeFrame: 12 weeks
measure: Post-Concussive Symptoms
timeFrame: 18 weeks
measure: Fatigue
timeFrame: 6 weeks
measure: Fatigue
timeFrame: 12 Weeks
measure: Fatigue
timeFrame: 18 Weeks
measure: Change in Healthcare Utilization
timeFrame: 30 days prior to Baseline and 6 months post Baseline
measure: Self Reported Quality of Life
timeFrame: 6 weeks
measure: Self Reported Quality of Life
timeFrame: 12 weeks
measure: Self Reported Quality of Life
timeFrame: 18 weeks
measure: Neuropsychological Status
timeFrame: 6 Weeks
measure: Neuropsychological Status
timeFrame: 12 Weeks
measure: Neuropsychological Status
timeFrame: 18 Weeks
measure: Self Reported Alcohol Use Behaviors
timeFrame: 6 weeks
measure: Self Reported Alcohol Use Behaviors
timeFrame: 12 weeks
measure: Self Reported Alcohol Use Behaviors
timeFrame: 18 weeks
measure: Post-Traumatic Stress Symptomatology
timeFrame: 6 weeks
measure: Post-Traumatic Stress Symptomatology
timeFrame: Baseline
measure: Post-Traumatic Stress Symptomatology
timeFrame: 12 Weeks
measure: Self Reported Headache Disability
timeFrame: 6 weeks
measure: Self Reported Headache Disability
timeFrame: 12 weeks
measure: Self Reported Headache Disability
timeFrame: 18 Weeks
measure: Health Related (Cognition) Locus of Control
timeFrame: 6 weeks
measure: Health Related (Cognition) Locus of Control
timeFrame: 12 weeks
measure: Health Related (Cognition) Locus of Control
timeFrame: 18 weeks
measure: Perceived Self-Efficacy (Cognition)
timeFrame: 6 weeks
measure: Perceived Self-Efficacy (Cognition)
timeFrame: 12 weeks
measure: Perceived Self-Efficacy (Cognition)
timeFrame: 18 weeks
measure: Attribution of Cognitive Symptoms
timeFrame: 6 weeks
measure: Attribution of Cognitive Symptoms
timeFrame: 12 weeks
measure: Attribution of Cognitive Symptoms
timeFrame: 18 weeks
measure: Therapist-Rated Patient Engagement in Treatment
timeFrame: Week 1 of Treatment
measure: Therapist-Rated Patient Engagement in Treatment
timeFrame: Week 2 of treatment
measure: Therapist-Rated Patient Engagement in Treatment
timeFrame: Week 3 of treatment
measure: Therapist-Rated Patient Engagement in Treatment
timeFrame: Week 4 of treatment
measure: Therapist-Rated Patient Engagement in Treatment
timeFrame: Week 5 of treatment
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: BAMC
name: Amy O Bowles, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cooper DB, Bowles AO, Kennedy JE, Curtiss G, French LM, Tate DF, Vanderploeg RD. Cognitive Rehabilitation for Military Service Members With Mild Traumatic Brain Injury: A Randomized Clinical Trial. J Head Trauma Rehabil. 2017 May/Jun;32(3):E1-E15. doi: 10.1097/HTR.0000000000000254.