The Effects of MBSR on Patients With TBI and Chronic Insomnia

Status unconfirmed · Not applicable

Conditions studied: Chronic Insomnia, TBI (Traumatic Brain Injury)

In brief

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.

Key facts

Study ID

NCT03560843

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

50

Starts

2018-04-12

Expected to finish

2019-09-01

Last updated by the study team

2018-06-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with mild-to-moderate TBI (as defined by the DoD criteria)
• Right-handedness
• Insomnia Severity Index ≥15
• DEERS eligible at the time of enrollment
• Not pregnant
• Male and female subjects 18 to 60 years old
• Insomnia disorder per DSM-V criteria

You may not qualify if…

• Inability to speak or understand English (because this is a group intervention, it requires a common language)
• Patients who require assistance with activities of daily living (ADLs)
• Active practice of meditation and/or yoga or participation in meditation/yoga classes in the last 6 months prior to enrollment
• Signs or symptoms of upper motor neuron syndrome, any major systemic illness or unstable condition which could interfere with protocol compliance
• 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
• A history of alcohol/substance abuse or dependence within the past 6 months
• Any neurosurgical intervention affecting brain parenchyma
• Unstable seizure activity
• 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
• Females who are pregnant or planning to become pregnant in 6 months following screening.

Where it is running

• Fort Belvoir Community Hospital — Fort Belvoir, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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