The Effects of MBSR on Patients With TBI and Chronic Insomnia

Randomized, controlled trial with 1:1 randomization (n=50). The control group will receive
the usual care for TBI through the clinical program with standard providers based on usual
patient evaluation and needs. The intervention group will receive MBSR in addition to the
usual care through the TBI program.

The usual care pathway will include physician visits, rehabilitation therapies (PT/OT/ST/et
al), and other providers as needed based on recommendations by his or her providers. Some
variability will exist, but withholding standard of care would be unethical and standardizing
care would be impossible. However, providers will be asked that medications, et al that could
affect sleep remain unchanged during the trial period (maximum 12 weeks), which is reasonable
given that patients have a chronic injury and no emergent/acute needs based on
inclusion/exclusion criteria.

Subjects in a control group will be offered complimentary MBSR after 6 month follow up visit
is completed.

Inclusion Criteria:

1. Patients with mild-to-moderate TBI (as defined by the DoD criteria)

2. Right-handedness

3. Insomnia Severity Index ≥15

4. DEERS eligible at the time of enrollment

5. Not pregnant

6. Male and female subjects 18 to 60 years old

7. Insomnia disorder per DSM-V criteria

Exclusion Criteria:

1. Inability to speak or understand English (because this is a group intervention, it
requires a common language)

2. Patients who require assistance with activities of daily living (ADLs)

3. Active practice of meditation and/or yoga or participation in meditation/yoga classes
in the last 6 months prior to enrollment

4. Signs or symptoms of upper motor neuron syndrome, any major systemic illness or
unstable condition which could interfere with protocol compliance

5. Active psychiatric disease that would interfere with participation in the trial,
psychotic features, agitation, or behavioral problems within the last 3 months that
could interfere with protocol compliance

6. A history of alcohol/substance abuse or dependence within the past 6 months

7. Any neurosurgical intervention affecting brain parenchyma

8. Unstable seizure activity

9. Concurrent participation in another clinical research trial with investigational drug
or previous participation with the last investigational drug administered less than 4
weeks prior to screening

10. Females who are pregnant or planning to become pregnant in 6 months following
screening.