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MBSR treatment for Traumatic Brain Injury

N/A
Waitlist Available
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Awards & highlights

Study 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.

Eligible Conditions
  • Traumatic Brain Injury
  • Chronic Insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Decrease in total score of Insomnia Severity Index (ISI) scale.
Secondary outcome measures
Any changes in blood biomarkers
Change in FSS (Fatigue Severity Scale score)
Change in MAAS (Mindful Attention Awareness Scale score)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MBSR treatmentExperimental Treatment1 Intervention
MBSR will be administered over 8 week period.
Group II: Control groupActive Control1 Intervention
Usual care will continue for this group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MBSR
2016
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
92 Previous Clinical Trials
92,839 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
The Effects of MBSR on Patients With TBI and Chronic Insomnia
2018. "The Effects of MBSR on Patients With TBI and Chronic Insomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03560843.
All > Tb > Insomnia
~7 spots leftby Apr 2025
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