Chronic InsomniaNCT03560843
The Effects of MBSR on Patients With TBI and Chronic Insomnia
A study testing MBSR in people with Chronic Insomnia and TBI (Traumatic Brain Injury), run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Insomnia, TBI (Traumatic Brain Injury)
- What is being tested?
- MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2018to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
Svetlana R Ho, 571-231-2936, svetlana.r.ho.ctr@mail.mil
John K Werner, MD, PhD
About this study
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.
Read the 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)
- Being tested
- MBSR
- Keywords
- MBSR, TBI, insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Mindfulness Based Stress Reduction
| Study group | Role | What they receive |
|---|---|---|
| MBSR treatment | Experimental | MBSR will be administered over 8 week period. Receives: Behavioral: MBSR |
| Control group | No intervention | Usual care will continue for this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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)
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.
Measured: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
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.
Measured: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
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.
Measured: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
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.
Measured: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
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.
Measured: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
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.
Measured: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start12 Apr 2018
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560843
- Sponsor's protocol ID
- 900001
- Status last verified
- Jun 2018
- First submitted
- 13 Mar 2018
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22794665Azulay 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.
PubMed 22688212Hubbling 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.
PubMed 24512477
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Based Stress Reduction (MBSR) on Patients With Traumatic Brain Injury and Chronic Insomnia
- ClinicalTrials.gov ID
- NCT03560843
- Acronym / sponsor ID
- 900001
- Conditions
- Chronic Insomnia, TBI (Traumatic Brain Injury)
- Keywords
- MBSR, TBI, insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MBSR treatment | Experimental | Behavioral: MBSRMBSR will be administered over 8 week period. |
| Control group | No intervention | –Usual care will continue for this group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSRMindfulness Based Stress Reduction | Behavioural | MBSR treatment |
Primary outcome
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
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.
10 secondary outcomes
Change in cognitive function as measured by NIH toolbox
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Change in MAAS (Mindful Attention Awareness Scale score)
Time frame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Change in PSS (Perceived Stress Scale)
Time frame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Change in NSI (Neurobehavioral Symptom Inventory scale) score
Time frame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Any changes in blood biomarkers
Time frame: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
Changes in SE- sleep efficiency measured 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Background: PubMed 22794665Johansson 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.
- Background: PubMed 22688212Azulay 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.
- Background: PubMed 24512477Hubbling 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR in people with Chronic Insomnia and TBI (Traumatic Brain Injury), run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03560843, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.