Back to resultsThe Effects of MBSR on Patients With TBI and Chronic Insomnia
Primary Purpose
Chronic Insomnia, TBI (Traumatic Brain Injury)
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBSR
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insomnia focused on measuring MBSR, TBI, insomnia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Fort Belvoir Community HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MBSR treatment
Control group
Arm Description
MBSR will be administered over 8 week period.
Usual care will continue for this group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in cognitive function as measured by NIH toolbox
Compare changes in cognitive assessment measured by National Institute of Health (NIH) Toolbox between the groups and at baseline and 2 week follow up within the group.
Change in PCL-5 (Post Traumatic Stress Disorder Check List-5) score
Compare changes in total scores in PTSD Check List-5 (PCL-5) (range 0-80) scores between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. PCL-5 measures symptoms of PTSD (post traumatic stress disorder) for initial provisional diagnosis, to monitor symptoms before and after treatment and screening individuals for PTSD so they can be appropriately followed by the clinicians. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. symptom cluster severity scores can be obtained by summing the scores for the items within a given cluster. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D item
Change in RAND-36 (RAND corporation 36 item Health Survey) score
Compare changes in total scores in RAND corporation 36 item Health Survey (RAND-36 range 0-100 on each item) between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. RAND-36 measures eight concepts: physical functioning, bodily pain, limitations due to physical health problems, limitations due to emotional or personal problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. It also includes a single item that provides an indication of perceived change in health.Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In
Change in PHQ-9 (Patient Health Questionnaire 9) score
Compare changes in total scores in Patient Health Questionnaire 9 (PHQ-9, score range 0-27) between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. PHQ-9 assesses depression. Scoring: add up all checked boxes on PHQ-9 For every checked Not at all = 0; Several days = 1;More than half the days = 2; Nearly every day = 3, Interpretation of Total (sum of all items) Score: 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression
Change in FSS (Fatigue Severity Scale score)
Compare changes in total scores in Fatigue Severity Scale (FSS, score range 9-63) between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on participant. The FSS is a short questionnaire that requires participant to rate their level of fatigue. The FSS questionnaire contains nine statements that rate the severity of participant's fatigue symptoms.A total score of less than 36 suggests that participant may not be suffering from fatigue. A total score of 36 or more suggests that participant may need further evaluation by a physician.
Change in MAAS (Mindful Attention Awareness Scale score)
Compare changes in total scores in Mindful Attention Awareness Scale (MAAS, score range 15-90) between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. This is in contrast to the conceptually driven mode of processing, in which events and experiences are filtered through cognitive appraisals, evaluations, memories, beliefs, and other forms of cognitive manipulation.To score the scale, simply compute a mean (average) of the 15 items. Higher scores reflect higher levels of dispositional mindfulness.
Change in PSS (Perceived Stress Scale)
Compare changes in total scores Perceived Stress Scale (PSS, score range 0-40) between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. The PSS is a global assessment of an individual's perception of psychological stress during the past month. scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items.Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Change in NSI (Neurobehavioral Symptom Inventory scale) score
Compare changes in total scores in Neurobehavioral Symptom Inventory (NSI, range 0-88) between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. The NSI is widely used in the Department of Defense (DoD) for the evaluation of post-concussive symptoms in service members (SMs). In addition, the Department of Veterans Affairs (VA) uses the NSI in its comprehensive traumatic brain injury (TBI) evaluation. Scores are summed at initial visit and follow up visit. number of symptoms of moderate, severe, and very severe intensity and a list of the specific symptoms in each of these rating categories. Change in individual symptom scores of two or more points in a positive direction consistent with recovery (i.e. very severe to moderate, mild or none; severe to mild or none; moderate to none). Change in individual symptom scores of two or more points indicative of symptom worsening or deterioration.
Any changes in blood biomarkers
Compare any changes in biomarkers - cytokines (il-6, IL-10, TNFa), tau, BDNF, IGF-1, amyloid beta 40/42, and melatonin measured at pg/ml at baseline and 2 week follow up.
Changes in SE- sleep efficiency measured by actigraphy devices and polysomnography.
to compare sleep sleep efficiency in % as calculated by total time asleep/total sleep time determined by actigraphy devices and polysomnography.
Full Information
NCT ID
NCT03560843
First Posted
March 13, 2018
Last Updated
June 15, 2018
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03560843
Brief Title
The Effects of MBSR on Patients With TBI and Chronic Insomnia
Official Title
The Effect of Mindfulness Based Stress Reduction (MBSR) on Patients With Traumatic Brain Injury and Chronic Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 12, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia, TBI (Traumatic Brain Injury)
Keywords
MBSR, TBI, insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MBSR treatment
Arm Type
Experimental
Arm Description
MBSR will be administered over 8 week period.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care will continue for this group.
Intervention Type
Behavioral
Intervention Name(s)
MBSR
Intervention Description
Mindfulness Based Stress Reduction
Primary Outcome Measure Information:
Title
Decrease in total score of Insomnia Severity Index (ISI) scale.
Description
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.
Time Frame
Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Secondary Outcome Measure Information:
Title
Change in cognitive function as measured by NIH toolbox
Description
Compare changes in cognitive assessment measured by National Institute of Health (NIH) Toolbox between the groups and at baseline and 2 week follow up within the group.
Time Frame
Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Title
Change in PCL-5 (Post Traumatic Stress Disorder Check List-5) score
Description
Compare changes in total scores in PTSD Check List-5 (PCL-5) (range 0-80) scores between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. PCL-5 measures symptoms of PTSD (post traumatic stress disorder) for initial provisional diagnosis, to monitor symptoms before and after treatment and screening individuals for PTSD so they can be appropriately followed by the clinicians. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. symptom cluster severity scores can be obtained by summing the scores for the items within a given cluster. A provisional PTSD diagnosis can be made by treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D item
Time Frame
Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Title
Change in RAND-36 (RAND corporation 36 item Health Survey) score
Description
Compare changes in total scores in RAND corporation 36 item Health Survey (RAND-36 range 0-100 on each item) between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. RAND-36 measures eight concepts: physical functioning, bodily pain, limitations due to physical health problems, limitations due to emotional or personal problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. It also includes a single item that provides an indication of perceived change in health.Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In
Time Frame
Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Title
Change in PHQ-9 (Patient Health Questionnaire 9) score
Description
Compare changes in total scores in Patient Health Questionnaire 9 (PHQ-9, score range 0-27) between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. PHQ-9 assesses depression. Scoring: add up all checked boxes on PHQ-9 For every checked Not at all = 0; Several days = 1;More than half the days = 2; Nearly every day = 3, Interpretation of Total (sum of all items) Score: 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression
Time Frame
Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Title
Change in FSS (Fatigue Severity Scale score)
Description
Compare changes in total scores in Fatigue Severity Scale (FSS, score range 9-63) between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on participant. The FSS is a short questionnaire that requires participant to rate their level of fatigue. The FSS questionnaire contains nine statements that rate the severity of participant's fatigue symptoms.A total score of less than 36 suggests that participant may not be suffering from fatigue. A total score of 36 or more suggests that participant may need further evaluation by a physician.
Time Frame
Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Title
Change in MAAS (Mindful Attention Awareness Scale score)
Description
Compare changes in total scores in Mindful Attention Awareness Scale (MAAS, score range 15-90) between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. This is in contrast to the conceptually driven mode of processing, in which events and experiences are filtered through cognitive appraisals, evaluations, memories, beliefs, and other forms of cognitive manipulation.To score the scale, simply compute a mean (average) of the 15 items. Higher scores reflect higher levels of dispositional mindfulness.
Time Frame
Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Title
Change in PSS (Perceived Stress Scale)
Description
Compare changes in total scores Perceived Stress Scale (PSS, score range 0-40) between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. The PSS is a global assessment of an individual's perception of psychological stress during the past month. scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items.Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Time Frame
Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Title
Change in NSI (Neurobehavioral Symptom Inventory scale) score
Description
Compare changes in total scores in Neurobehavioral Symptom Inventory (NSI, range 0-88) between the groups at baseline, 2 week follow up and 6 month follow and within the group at time points indicated. The NSI is widely used in the Department of Defense (DoD) for the evaluation of post-concussive symptoms in service members (SMs). In addition, the Department of Veterans Affairs (VA) uses the NSI in its comprehensive traumatic brain injury (TBI) evaluation. Scores are summed at initial visit and follow up visit. number of symptoms of moderate, severe, and very severe intensity and a list of the specific symptoms in each of these rating categories. Change in individual symptom scores of two or more points in a positive direction consistent with recovery (i.e. very severe to moderate, mild or none; severe to mild or none; moderate to none). Change in individual symptom scores of two or more points indicative of symptom worsening or deterioration.
Time Frame
Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Title
Any changes in blood biomarkers
Description
Compare any changes in biomarkers - cytokines (il-6, IL-10, TNFa), tau, BDNF, IGF-1, amyloid beta 40/42, and melatonin measured at pg/ml at baseline and 2 week follow up.
Time Frame
Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Title
Changes in SE- sleep efficiency measured by actigraphy devices and polysomnography.
Description
to compare sleep sleep efficiency in % as calculated by total time asleep/total sleep time determined by actigraphy devices and polysomnography.
Time Frame
Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Facility Information:
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svetlana R Ho
Phone
571-231-2936
Email
svetlana.r.ho.ctr@mail.mil
First Name & Middle Initial & Last Name & Degree
John K Werner, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22794665
Citation
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.
Results Reference
background
PubMed Identifier
22688212
Citation
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.
Results Reference
background
PubMed Identifier
24512477
Citation
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.
Results Reference
background
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The Effects of MBSR on Patients With TBI and Chronic Insomnia
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