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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03171519 -
Effects of Exercise and Acupuncture on Chronic Insomnia
|
N/A | |
| Completed |
NCT02515006 -
Impact of Homeopathy for Persistent Insomnia in Patients With Cancer
|
N/A | |
| Recruiting |
NCT05247697 -
Mirtazapine for Chronic Insomnia in Older Adults
|
Phase 1 | |
| Active, not recruiting |
NCT04366284 -
Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
|
N/A | |
| Active, not recruiting |
NCT04350866 -
Enhancing Access to Insomnia Care in VA PCMHI Clinics
|
||
| Recruiting |
NCT04761796 -
Sleep Time and Insomnia Factors Among Professional Flight Members
|
||
| Completed |
NCT02688569 -
Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study
|
N/A | |
| Completed |
NCT02236845 -
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients
|
N/A | |
| Completed |
NCT01949389 -
Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders
|
N/A | |
| Completed |
NCT00414102 -
Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.
|
Phase 4 | |
| Completed |
NCT00671294 -
Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia.
|
Phase 3 | |
| Completed |
NCT02392000 -
Mobile Sleep Intervention for OEF, OIF and OND Veterans
|
N/A | |
| Recruiting |
NCT04471168 -
Interest of Auriculotherapy in the Management of Chronic Insomnia
|
N/A | |
| Completed |
NCT02774642 -
Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)
|
N/A | |
| Completed |
NCT02290405 -
Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
|
||
| Completed |
NCT05618002 -
Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
|
||
| Completed |
NCT01995838 -
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia
|
Phase 2 | |
| Recruiting |
NCT05457790 -
Feasibility and Preliminary Efficacy of Acceptance and Commitment Therapy (ACT) for Sleep Disturbances in Adults With Sickle Cell Disease (SCD)
|
N/A | |
| Completed |
NCT02272712 -
The Effectiveness of Online Treatment for Insomnia in Cancer Survivors
|
N/A | |
| Completed |
NCT00915135 -
Efficacy and Safety of Ramelteon on Chronic Insomnia
|
Phase 2 |