Chronic Insomnia Clinical Trial
Official title:
The Effect of Mindfulness Based Stress Reduction (MBSR) on Patients With Traumatic Brain Injury and Chronic Insomnia
To evaluate the effects of Mindfulness Based Stress Reduction (MBSR) as an adjunct to usual clinical care for treatment of stress and chronic insomnia for patients with mild to moderate traumatic brain injury (MTBI). MBSR is a standardized protocol of meditation and yoga that has been studied extensively in other populations, however the effects of MBSR have not yet been well studied in the proposed population of service members with a Traumatic Brain Injury (TBI) who are experiencing 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.
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