Recruiting

MBSR

Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Code:

NCT03560843

Conditions

Chronic Insomnia

TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

MBSR

Study Details

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.

Conditions

Chronic Insomnia

TBI (Traumatic Brain Injury)

Study ID

NCT03560843

Start date

Apr 12, 2018

Status verified date

Jun, 2018

Completion date

Sep, 2019

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MBSR treatment

MBSR will be administered over 8 week period.

no intervention: Control group

Usual care will continue for this group.

Interventions

MBSR

Mindfulness Based Stress Reduction

Primary outcome measure

  • Decrease in total score of Insomnia Severity Index (ISI) scale. [ Time Frame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion ]

Central Contacts and Locations

Locations

Fort Belvoir Community Hospital

Recruiting

Fort Belvoir, Virginia, United States, 22060

Contacts

Principal Investigator:

John K Werner, MD, PhD

More Information

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Last update posted

Jun 18, 2018

Last verified

Jun, 2018

Keywords

  • MBSR, TBI, insomnia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine on 2018-06-18.