The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury

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.

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).