Clinical trial NCT03560843: The Effects of MBSR on Patients With TBI and Chronic Insomnia
Official title: The Effect of Mindfulness Based Stress Reduction (MBSR) on Patients With Traumatic Brain Injury and Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Insomnia
TBI (Traumatic Brain Injury)
Keywords: MBSR, TBI, insomnia
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: MBSR is an 8 week standardized protocol that includes gentle yoga, meditation, and mindfulness practices that were originally developed by Jon Kabat-Zinn from the University of Massachusetts. A trained MBSR instructor will lead group sessions weekly for approximately 150-210 minutes to teach and demonstrate the practices. Practices include walking/standing/supine meditation, body scanning (drawing attention to various areas of the body such as the right foot or left hand), and simple hatha yoga postures.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decrease in total score of Insomnia Severity Index (ISI) scale.
timeFrame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Secondary outcomes:
measure: Change in cognitive function as measured by NIH toolbox
timeFrame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
measure: Change in PCL-5 (Post Traumatic Stress Disorder Check List-5) score
timeFrame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
measure: Change in RAND-36 (RAND corporation 36 item Health Survey) score
timeFrame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
measure: Change in PHQ-9 (Patient Health Questionnaire 9) score
timeFrame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
measure: Change in FSS (Fatigue Severity Scale score)
timeFrame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
measure: Change in MAAS (Mindful Attention Awareness Scale score)
timeFrame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
measure: Change in PSS (Perceived Stress Scale)
timeFrame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
measure: Change in NSI (Neurobehavioral Symptom Inventory scale) score
timeFrame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
measure: Any changes in blood biomarkers
timeFrame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
measure: Changes in SE- sleep efficiency measured by actigraphy devices and polysomnography.
timeFrame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Other outcomes:
Locations:
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
Study officials:
References:
citation: Johansson B, Bjuhr H, Ronnback L. Mindfulness-based stress reduction (MBSR) improves long-term mental fatigue after stroke or traumatic brain injury. Brain Inj. 2012;26(13-14):1621-8. doi: 10.3109/02699052.2012.700082. Epub 2012 Jul 13.
citation: Azulay J, Smart CM, Mott T, Cicerone KD. A pilot study examining the effect of mindfulness-based stress reduction on symptoms of chronic mild traumatic brain injury/postconcussive syndrome. J Head Trauma Rehabil. 2013 Jul-Aug;28(4):323-31. doi: 10.1097/HTR.0b013e318250ebda.
citation: Hubbling A, Reilly-Spong M, Kreitzer MJ, Gross CR. How mindfulness changed my sleep: focus groups with chronic insomnia patients. BMC Complement Altern Med. 2014 Feb 10;14:50. doi: 10.1186/1472-6882-14-50.