The Effects of MBSR on Patients With TBI and Chronic Insomnia

NCT ID: NCT03560843

Last Updated: 2018-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-12
• Study Completion Date: 2019-09-30

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.

Conditions

Chronic Insomnia; TBI (Traumatic Brain Injury)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MBSR treatment

MBSR will be administered over 8 week period.

Group Type: EXPERIMENTAL

MBSR

Intervention Type: BEHAVIORAL

Mindfulness Based Stress Reduction

Control group

Usual care will continue for this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MBSR

Mindfulness Based Stress Reduction

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Svetlana R Ho

Role: primary

svetlana.r.ho.ctr@mail.mil

571-231-2936

References

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.

Reference Type: BACKGROUND

PMID: 22794665 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22688212 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24512477 (View on PubMed)

Other Identifiers

900001

Identifier Type: -

Identifier Source: org_study_id