Traumatic Brain Injury With Brief Loss of ConsciousnessPhase 4SCORENCT01339806
The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury
A Phase 4 study testing Cognitive Rehab, Brainworks and Informational Handout/Provider Visits in people with Traumatic Brain Injury With Brief Loss of Consciousness and Traumatic Brain Injury With No Loss of Consciousness, run by Brooke Army Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury With Brief Loss of Consciousness, Traumatic Brain Injury With No Loss of Consciousness
- What is being tested?
- Cognitive Rehab, Brainworks and Informational Handout/Provider Visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
San Antonio, Texas, 78234
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Brain Injury With Brief Loss of Consciousness, Traumatic Brain Injury With No Loss of Consciousness
- Being tested
- Cognitive Rehab, Brainworks, Informational Handout/Provider Visits
- Keywords
- mTBI, Concussion
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RehabBehavioural
Also called APT-III
APT-III, Other standard individual and group interventions.
BrainworksBehavioural
Also called POSIT
POSIT
Informational Handout/Provider VisitsBehavioural
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care for mTBI Provider Arm | Other | 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). Receives: Behavioral: Informational Handout/Provider Visits |
| Computer Based Therapy Group | Experimental | 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." Receives: Behavioral: Brainworks; Behavioral: Informational Handout/Provider Visits |
| Cognitive Rehab Group | Experimental | 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. Receives: Behavioral: Cognitive Rehab; Behavioral: Informational Handout/Provider Visits |
| Cognitive and Psychological Based Rehab | Experimental | 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. Receives: Behavioral: Cognitive Rehab; Behavioral: Informational Handout/Provider Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 Weeks
Secondary outcomes (47)
Fatigue
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
Measured: Baseline
Post-Concussive Symptoms
Neurobehavioral Symptom Inventory Total Raw scale 22 individual items
Measured: 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
Measured: 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
Measured: Baseline
Self Reported Alcohol Use Behaviors
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
Measured: Baseline
Post-Traumatic Stress Symptomatology
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
Measured: 18 Weeks
Self Reported Headache Disability
Headache Impact Test-6 (HIT-6) Total Weighted Score
Measured: Baseline
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
Measured: Baseline
Perceived Self-Efficacy (Cognition)
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
Measured: Baseline
Attribution of Cognitive Symptoms
Cognitive Symptom Attribution Scale 7 individual items
Measured: Baseline
Therapist-Rated Patient Engagement in Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Measured: Week 6 of treatment
Post-Concussive Symptoms
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
Measured: 6 Weeks
Post-Concussive Symptoms
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
Measured: 12 weeks
Post-Concussive Symptoms
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
Measured: 18 weeks
Fatigue
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
Measured: 6 weeks
Fatigue
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
Measured: 12 Weeks
Fatigue
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 Weeks
Self Reported Alcohol Use Behaviors
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
Measured: 6 weeks
Self Reported Alcohol Use Behaviors
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
Measured: 12 weeks
Self Reported Alcohol Use Behaviors
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
Measured: 18 weeks
Post-Traumatic Stress Symptomatology
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
Measured: 6 weeks
Post-Traumatic Stress Symptomatology
Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items
Measured: Baseline
Post-Traumatic Stress Symptomatology
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
Measured: 12 Weeks
Self Reported Headache Disability
Headache Impact Test-6 (HIT-6) Total Weighted Score
Measured: 6 weeks
Self Reported Headache Disability
Headache Impact Test-6 (HIT-6) Total Weighted Score
Measured: 12 weeks
Self Reported Headache Disability
Headache Impact Test-6 (HIT-6) Total Weighted Score
Measured: 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
Measured: 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
Measured: 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
Measured: 18 weeks
Perceived Self-Efficacy (Cognition)
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
Measured: 6 weeks
Perceived Self-Efficacy (Cognition)
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
Measured: 12 weeks
Perceived Self-Efficacy (Cognition)
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
Measured: 18 weeks
Attribution of Cognitive Symptoms
Cognitive Symptom Attribution Scale 7 individual items
Measured: 6 weeks
Attribution of Cognitive Symptoms
Cognitive Symptom Attribution Scale 7 individual items
Measured: 12 weeks
Attribution of Cognitive Symptoms
Cognitive Symptom Attribution Scale 7 individual items
Measured: 18 weeks
Therapist-Rated Patient Engagement in Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Measured: Week 1 of Treatment
Therapist-Rated Patient Engagement in Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Measured: Week 2 of treatment
Therapist-Rated Patient Engagement in Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Measured: Week 3 of treatment
Therapist-Rated Patient Engagement in Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Measured: Week 4 of treatment
Therapist-Rated Patient Engagement in Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Measured: Week 5 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain Injury With Brief Loss of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- The Defense and Veterans Brain Injury Center, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Principal investigator, Amy Bowles, M.D., Brooke Army Medical Center
- Investigators
- Amy O Bowles, MD, Principal investigator, BAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339806
- Sponsor's protocol ID
- C.2010.199
- Acronym
- SCORE
- Status last verified
- Feb 2015
- First submitted
- 15 Apr 2011
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29878826Cooper 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.
PubMed 27603763
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01339806
- Acronym / sponsor ID
- SCORE / C.2010.199
- Conditions
- Traumatic Brain Injury With Brief Loss of Consciousness, Traumatic Brain Injury With No Loss of Consciousness
- Keywords
- mTBI, Concussion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- The Defense and Veterans Brain Injury Center, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- Jun 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of Care for mTBI Provider Arm | Other | Behavioral: Informational Handout/Provider VisitsArm 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). |
| Computer Based Therapy Group | Experimental | Behavioral: Brainworks, Behavioral: Informational Handout/Provider VisitsArm 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." |
| Cognitive Rehab Group | Experimental | Behavioral: Cognitive Rehab, Behavioral: Informational Handout/Provider VisitsArm 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. |
| Cognitive and Psychological Based Rehab | Experimental | Behavioral: Cognitive Rehab, Behavioral: Informational Handout/Provider VisitsArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive RehabAlso: APT-IIIAPT-III, Other standard individual and group interventions. | Behavioural | Cognitive Rehab Group, Cognitive and Psychological Based Rehab |
| BrainworksAlso: POSITPOSIT | Behavioural | Computer Based Therapy Group |
| Informational Handout/Provider VisitsProvider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures. | Behavioural | Cognitive Rehab Group, Cognitive and Psychological Based Rehab, Computer Based Therapy Group, Standard of Care for mTBI Provider Arm |
Primary outcome
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
47 secondary outcomes
Fatigue
Time frame: Baseline
Post-Concussive Symptoms
Time frame: Baseline
Self Reported Quality of Life
Time frame: Baseline
Neuropsychological Status
Time frame: Baseline
Self Reported Alcohol Use Behaviors
Time frame: Baseline
Post-Traumatic Stress Symptomatology
Time frame: 18 Weeks
Self Reported Headache Disability
Time frame: Baseline
Health Related (Cognition) Locus of Control
Time frame: Baseline
Perceived Self-Efficacy (Cognition)
Time frame: Baseline
Attribution of Cognitive Symptoms
Time frame: Baseline
Therapist-Rated Patient Engagement in Treatment
Time frame: Week 6 of treatment
Post-Concussive Symptoms
Time frame: 6 Weeks
Post-Concussive Symptoms
Time frame: 12 weeks
Post-Concussive Symptoms
Time frame: 18 weeks
Fatigue
Time frame: 6 weeks
Fatigue
Time frame: 12 Weeks
Fatigue
Time frame: 18 Weeks
Change in Healthcare Utilization
Time frame: 30 days prior to Baseline and 6 months post Baseline
Self Reported Quality of Life
Time frame: 6 weeks
Self Reported Quality of Life
Time frame: 12 weeks
Self Reported Quality of Life
Time frame: 18 weeks
Neuropsychological Status
Time frame: 6 Weeks
Neuropsychological Status
Time frame: 12 Weeks
Neuropsychological Status
Time frame: 18 Weeks
Self Reported Alcohol Use Behaviors
Time frame: 6 weeks
Self Reported Alcohol Use Behaviors
Time frame: 12 weeks
Self Reported Alcohol Use Behaviors
Time frame: 18 weeks
Post-Traumatic Stress Symptomatology
Time frame: 6 weeks
Post-Traumatic Stress Symptomatology
Time frame: Baseline
Post-Traumatic Stress Symptomatology
Time frame: 12 Weeks
Self Reported Headache Disability
Time frame: 6 weeks
Self Reported Headache Disability
Time frame: 12 weeks
Self Reported Headache Disability
Time frame: 18 Weeks
Health Related (Cognition) Locus of Control
Time frame: 6 weeks
Health Related (Cognition) Locus of Control
Time frame: 12 weeks
Health Related (Cognition) Locus of Control
Time frame: 18 weeks
Perceived Self-Efficacy (Cognition)
Time frame: 6 weeks
Perceived Self-Efficacy (Cognition)
Time frame: 12 weeks
Perceived Self-Efficacy (Cognition)
Time frame: 18 weeks
Attribution of Cognitive Symptoms
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
- Derived from this study: PubMed 29878826Vanderploeg 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.
- Derived from this study: PubMed 27603763Cooper 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.
- Defense and Veterans Brain Injury CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy O Bowles, MD principal investigator
BAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive Rehab, Brainworks and Informational Handout/Provider Visits in people with Traumatic Brain Injury With Brief Loss of Consciousness and Traumatic Brain Injury With No Loss of Consciousness, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Functioning (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01339806, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.