<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03827928</url>
  </required_header>
  <id_info>
    <org_study_id>D19058</org_study_id>
    <nct_id>NCT03827928</nct_id>
  </id_info>
  <brief_title>LoveYourBrain Yoga for Multiple Sclerosis</brief_title>
  <official_title>The Acceptability, Feasibility, and Impact of a Group-based Yoga and Psychoeducation Program for Community-dwelling Adults With Multiple Sclerosis: A Randomized, Cross-over Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess the feasibility of a 6-week yoga and meditation&#xD;
      intervention for people with multiple sclerosis (MS). The study will evaluate the impact of&#xD;
      the program on fatigue, anxiety, depression, positive affect, and other measures. A sub-study&#xD;
      will collect brain images using MRI on 2 subjects before and after the intervention to&#xD;
      identify potential biological markers of MS related-fatigue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will recruit 20 subjects with multiple sclerosis (MS) to participate in a 6-week&#xD;
      yoga/meditation program. Subjects will be randomly assigned to one of two groups. The first&#xD;
      group will complete the yoga/meditation classes, followed by a waiting period. The second&#xD;
      group will go through a waiting period, followed by yoga/meditation classes. Two subjects&#xD;
      assigned to classes during the first session will be selected to participate in an MRI&#xD;
      sub-study to look for biomarkers of MS-associated fatigue. All subjects will complete&#xD;
      questionnaires and assessments during 3 clinic visits - at baseline, in between the class&#xD;
      sessions, and at the end of the study. Questionnaires will also be mailed to subjects 6 weeks&#xD;
      after the last study visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of conducting a yoga intervention study</measure>
    <time_frame>At the clinic visit immediately following the yoga class session</time_frame>
    <description>The feasibility will be determined by the completion rates of the intervention. If fewer than 50% of subjects complete the intervention, it will be deemed unfeasible in the current format.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in subject self-rated fatigue</measure>
    <time_frame>Through study completion, approximately 22 weeks</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale for MS: 8-item measure of fatigue. Scale range 8 to 40. A lower score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subject self-rated self-efficacy</measure>
    <time_frame>Through study completion, approximately 22 weeks</time_frame>
    <description>Liverpool Self-efficacy scale: 17-item measure of self-efficacy. Scale range 17 to 68. A higher score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subject self-rated anxiety</measure>
    <time_frame>Through study completion, approximately 22 weeks</time_frame>
    <description>Neuro-Quality of Life (QOL) v1.0 Anxiety - Short Form: 8-item measure of anxiety. Scale range 8 to 40. A lower score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subject self-rated depression</measure>
    <time_frame>Through study completion, approximately 22 weeks</time_frame>
    <description>Neuro-Quality of Life (QOL) v1.0 Depression - Short Form: 8-item measure of depression. Scale range 8 to 40. A lower score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subject self-rated positive affect</measure>
    <time_frame>Through study completion, approximately 22 weeks</time_frame>
    <description>Neuro-Quality of Life (QOL) v1.0 Positive affect and well-being - Short form: 9-item measure of positive affect and well-being. Scale range 8 to 48. A higher score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subject cognition/processing speed</measure>
    <time_frame>Through study completion, approximately 22 weeks</time_frame>
    <description>Single Digit Modalities Test: Measure of cognition/processing speed. Score range 0 to 110. A higher score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subject self-rated sleep disturbance</measure>
    <time_frame>Through study completion, approximately 22 weeks</time_frame>
    <description>Neuro-QOL v1.0 Sleep disturbance - Short Form: 8-item measure of sleep disturbance. Scale range 8 to 40. A lower score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subject self-rated pain interference</measure>
    <time_frame>Through study completion, approximately 22 weeks</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) v1.0 Pain Interference - Short Form 6b: 6-item measure of sleep disturbance. Scale range 6 to 30. A lower score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subject self-rated quality of life</measure>
    <time_frame>Through study completion, approximately 22 weeks</time_frame>
    <description>Multiple Sclerosis Impact Scale (MSIS-29): 29-item measure of quality of life. Scale range 29 to 145. A lower score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subject self-rated cognitive function</measure>
    <time_frame>Through study completion, approximately 22 weeks</time_frame>
    <description>Neuro-Quality of Life (QOL) v2.0 Cognitive Function - Short Form: 8-item measure of cognitive function. Scale range 8 to 48. A higher score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction rating of 6-week yoga program on a scale of 1 - 10</measure>
    <time_frame>At the clinic visit immediately following the yoga/meditation class session</time_frame>
    <description>Satisfaction scale: Subjects will rate their satisfaction with the yoga program on a scale of 1 - 10. Higher scores indicate a better rating.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Yoga/meditation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 6-week yoga/meditation intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A wait list control period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga/meditation</intervention_name>
    <description>A 6-week yoga and meditation program with psychoeducation components, delivered through community-based yoga sessions. This program offers structured instruction: 10 minutes of breathing exercises to calm the nervous system, 45 minutes of gentle yoga to improve strength, flexibility, and balance, 15 minutes of guided meditation to enhance attention control, emotional regulation, and self-efficacy, and 20 minutes of facilitated discussion with psychoeducation to build community connection and skills in resilience.</description>
    <arm_group_label>Yoga/meditation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of Multiple Sclerosis with EDSS score equal to or less than 6 (within last&#xD;
             year)&#xD;
&#xD;
          2. 18 years of age or older&#xD;
&#xD;
          3. Ability to ambulate without assistance from a device or person&#xD;
&#xD;
          4. Subjects taking medications for depression, fatigue, or anxiety must be stable for 8&#xD;
             weeks prior to baseline&#xD;
&#xD;
          5. Able to read, write, and speak English&#xD;
&#xD;
          6. Willing to refrain from participating in yoga or meditation outside of the study for&#xD;
             the duration of enrollment&#xD;
&#xD;
          7. Willing and able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in yoga and/or meditation more than twice within 8 weeks prior to&#xD;
             baseline.&#xD;
&#xD;
          2. MS symptom exacerbation in the 8 weeks before baseline or other serious medical&#xD;
             conditions that would impair ability to participate in the study.&#xD;
&#xD;
          3. Any other reason that, in the investigator's opinion, would exclude the subject from&#xD;
             participation in the study.&#xD;
&#xD;
          4. Contraindication to scanning, including but not limited to ferromagnetic metal in the&#xD;
             body, claustrophobia, inability to lie still or otherwise tolerate being in the&#xD;
             scanner.&#xD;
&#xD;
          5. Pregnant women must be excluded from the imaging component of the study due to unknown&#xD;
             but possible risk of fetal exposure to the scanner. Women of child-bearing potential&#xD;
             will take a confidential pregnancy test immediately prior to each scan session.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Andrew D. Smith III</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03827928
org study id: D19058
nct id: NCT03827928
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to assess the feasibility of a 6-week yoga and meditation
      intervention for people with multiple sclerosis (MS). The study will evaluate the impact of
      the program on fatigue, anxiety, depression, positive affect, and other measures. A sub-study
      will collect brain images using MRI on 2 subjects before and after the intervention to
      identify potential biological markers of MS related-fatigue.
This study will recruit 20 subjects with multiple sclerosis (MS) to participate in a 6-week
      yoga/meditation program. Subjects will be randomly assigned to one of two groups. The first
      group will complete the yoga/meditation classes, followed by a waiting period. The second
      group will go through a waiting period, followed by yoga/meditation classes. Two subjects
      assigned to classes during the first session will be selected to participate in an MRI
      sub-study to look for biomarkers of MS-associated fatigue. All subjects will complete
      questionnaires and assessments during 3 clinic visits - at baseline, in between the class
      sessions, and at the end of the study. Questionnaires will also be mailed to subjects 6 weeks
      after the last study visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility of conducting a yoga intervention study
time frame: At the clinic visit immediately following the yoga class session
description: The feasibility will be determined by the completion rates of the intervention. If fewer than 50% of subjects complete the intervention, it will be deemed unfeasible in the current format.
measure: Change in subject self-rated fatigue
time frame: Through study completion, approximately 22 weeks
description: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale for MS: 8-item measure of fatigue. Scale range 8 to 40. A lower score represents a better outcome.
measure: Change in subject self-rated self-efficacy
time frame: Through study completion, approximately 22 weeks
description: Liverpool Self-efficacy scale: 17-item measure of self-efficacy. Scale range 17 to 68. A higher score represents a better outcome.
measure: Change in subject self-rated anxiety
time frame: Through study completion, approximately 22 weeks
description: Neuro-Quality of Life (QOL) v1.0 Anxiety - Short Form: 8-item measure of anxiety. Scale range 8 to 40. A lower score represents a better outcome.
measure: Change in subject self-rated depression
time frame: Through study completion, approximately 22 weeks
description: Neuro-Quality of Life (QOL) v1.0 Depression - Short Form: 8-item measure of depression. Scale range 8 to 40. A lower score represents a better outcome.
measure: Change in subject self-rated positive affect
time frame: Through study completion, approximately 22 weeks
description: Neuro-Quality of Life (QOL) v1.0 Positive affect and well-being - Short form: 9-item measure of positive affect and well-being. Scale range 8 to 48. A higher score represents a better outcome.
measure: Change in subject cognition/processing speed
time frame: Through study completion, approximately 22 weeks
description: Single Digit Modalities Test: Measure of cognition/processing speed. Score range 0 to 110. A higher score represents a better outcome.
measure: Change in subject self-rated sleep disturbance
time frame: Through study completion, approximately 22 weeks
description: Neuro-QOL v1.0 Sleep disturbance - Short Form: 8-item measure of sleep disturbance. Scale range 8 to 40. A lower score represents a better outcome.
measure: Change in subject self-rated pain interference
time frame: Through study completion, approximately 22 weeks
description: Patient-Reported Outcomes Measurement Information System (PROMIS) v1.0 Pain Interference - Short Form 6b: 6-item measure of sleep disturbance. Scale range 6 to 30. A lower score represents a better outcome.
measure: Change in subject self-rated quality of life
time frame: Through study completion, approximately 22 weeks
description: Multiple Sclerosis Impact Scale (MSIS-29): 29-item measure of quality of life. Scale range 29 to 145. A lower score represents a better outcome.
measure: Change in subject self-rated cognitive function
time frame: Through study completion, approximately 22 weeks
description: Neuro-Quality of Life (QOL) v2.0 Cognitive Function - Short Form: 8-item measure of cognitive function. Scale range 8 to 48. A higher score represents a better outcome.
measure: Satisfaction rating of 6-week yoga program on a scale of 1 - 10
time frame: At the clinic visit immediately following the yoga/meditation class session
description: Satisfaction scale: Subjects will rate their satisfaction with the yoga program on a scale of 1 - 10. Higher scores indicate a better rating.
arm group label: Yoga/meditation
arm group type: Experimental
description: A 6-week yoga/meditation intervention.
arm group label: Wait list
arm group type: No Intervention
description: A wait list control period.
intervention type: Behavioral
intervention name: Yoga/meditation
description: A 6-week yoga and meditation program with psychoeducation components, delivered through community-based yoga sessions. This program offers structured instruction: 10 minutes of breathing exercises to calm the nervous system, 45 minutes of gentle yoga to improve strength, flexibility, and balance, 15 minutes of guided meditation to enhance attention control, emotional regulation, and self-efficacy, and 20 minutes of facilitated discussion with psychoeducation to build community connection and skills in resilience.
arm group label: Yoga/meditation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Andrew D. Smith III
investigator title: Principal Investigator
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No