[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

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Condition

Chronic Insomnia,TBI (Traumatic Brain Injury)

Treatment type

Interventional

Investigational product

MBSR

Phase

N/A

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

ClinicalTrials.gov identifier

NCT03560843

Study number

900-001

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About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. 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. language) 2. Patients who require assistance with activities of daily living (
  2. 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.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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