The Effects of MBSR on Patients With TBI and Chronic Insomnia

NCT03560843 | Unknown

• 1 other identifier: 900001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Keywords

MBSR, TBI, insomnia

Outcome Measures

Primary Outcomes (1)

• Decrease in total score of Insomnia Severity Index (ISI) scale.

  compare change in Insomnia Severity Index (ISI, score range 0-28) scores at baseline, 2 week follow up and 6 month follow up. ISI measures severity of insomnia and calculated by adding the scores for all seven items. Results interpretation: 0-7 = No clinically significant insomnia; 8-14 = Subthreshold insomnia; 15-21 = Clinical insomnia (moderate severity); 22-28 = Clinical insomnia (severe). A 6 point decrease is considered clinically significant improvement in symptoms of insomnia.

  Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion

Secondary Outcomes (10)

• Change in cognitive function as measured by NIH toolbox

  Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion

• Change in PCL-5 (Post Traumatic Stress Disorder Check List-5) score

  Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion

• Change in RAND-36 (RAND corporation 36 item Health Survey) score

  Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion

• Change in PHQ-9 (Patient Health Questionnaire 9) score

  Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion

• Change in FSS (Fatigue Severity Scale score)

  Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion

Study Arms (2)

MBSR treatment

EXPERIMENTAL

MBSR will be administered over 8 week period.

Behavioral: MBSR

Control group

NO INTERVENTION

Usual care will continue for this group.

Interventions

MBSR BEHAVIORAL

Mindfulness Based Stress Reduction

MBSR treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with mild-to-moderate TBI (as defined by the DoD criteria)
• Right-handedness
• Insomnia Severity Index ≥15
• DEERS eligible at the time of enrollment
• Not pregnant
• Male and female subjects 18 to 60 years old
• Insomnia disorder per DSM-V criteria

You may not qualify if:

• Inability to speak or understand English (because this is a group intervention, it requires a common language)
• Patients who require assistance with activities of daily living (ADLs)
• Active practice of meditation and/or yoga or participation in meditation/yoga classes in the last 6 months prior to enrollment
• Signs or symptoms of upper motor neuron syndrome, any major systemic illness or unstable condition which could interfere with protocol compliance
• 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
• A history of alcohol/substance abuse or dependence within the past 6 months
• Any neurosurgical intervention affecting brain parenchyma
• Unstable seizure activity
• 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
• Females who are pregnant or planning to become pregnant in 6 months following screening.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead

Study Sites (1)

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, 22060, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 22794665 BACKGROUND

• 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.

  PMID: 22688212 BACKGROUND

• 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.

  PMID: 24512477 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: MBSR is an 8 week standardized protocol that includes gentle yoga, meditation, and mindfulness practices that were originally developed by Jon Kabat-Zinn from the University of Massachusetts. A trained MBSR instructor will lead group sessions weekly for approximately 150-210 minutes to teach and demonstrate the practices. Practices include walking/standing/supine meditation, body scanning (drawing attention to various areas of the body such as the right foot or left hand), and simple hatha yoga postures.

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: June 18, 2018
• Study Start: April 12, 2018
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: June 18, 2018

Record last verified: 2018-06

Locations

US (1)