<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/NCT02190474</url>
  </required_header>
  <id_info>
    <org_study_id>1201009502</org_study_id>
    <secondary_id>K23AT006703</secondary_id>
    <nct_id>NCT02190474</nct_id>
  </id_info>
  <brief_title>Mindfulness Interventions and Chronic Widespread Pain in Adolescents</brief_title>
  <official_title>Mindfulness Interventions and Chronic Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study to determine the feasibility and acceptability of a&#xD;
      mindfulness intervention for adolescents with juvenile fibromyalgia/ chronic widespread pain&#xD;
      and other similar chronic symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to test the feasibility, safety, tolerability and acceptability of a&#xD;
      mindfulness meditation intervention for adolescents with juvenile fibromyalgia/chronic&#xD;
      widespread pain.&#xD;
&#xD;
      The purpose of the program is to test how effective an 8-week meditation and stress reduction&#xD;
      class is in helping adolescents with chronic symptoms (including but not limited to&#xD;
      fibromyalgia or chronic widespread pain, irritable bowel syndrome, joint pain, chronic&#xD;
      fatigue, and others).&#xD;
&#xD;
      Participants will attend group sessions led by an instructor experienced in MBSR in an&#xD;
      academic setting. The mindfulness meditation group sessions will take place at the Yale&#xD;
      School of Medicine.&#xD;
&#xD;
      Participants will attend 90-minute weekly group sessions and a 4-hour retreat with&#xD;
      approximately 6-8 other study participants at Yale School of Medicine. Participants are asked&#xD;
      to practice at home by listening to pre-recorded 15-20 minute guided meditations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility and retention</measure>
    <time_frame>8 weeks</time_frame>
    <description>Feasibility and retention will be assessed after each cohort completes the group sessions. Feasibility of the intervention will be assessed by the proportion of eligible patients approached for the study who consent to participate and the proportion of the weekly sessions that are attended.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Program Adherence</measure>
    <time_frame>8 weeks</time_frame>
    <description>Program adherence will be tracked by assessing the actual amount of home practice in minutes per week using weekly self-report diaries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Program Use</measure>
    <time_frame>8 weeks</time_frame>
    <description>Program use will be assessed by quantifying the amount of minutes that participants spent practicing MBSR. Participants will agree to receive and respond to a daily question of &quot;How many minutes did you spend practicing MBSR yesterday&quot; delivered by SMS/text message to their mobile telephone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Program Practicality</measure>
    <time_frame>8 weeks</time_frame>
    <description>Program practicality will be qualitatively assessed. Practicality (ability to attend intervention sessions and practice at home), interest in the intervention, perceived effectiveness, will be collected through brief (15-20 min) interviews following completion of the 8-week intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Disability Inventory (FDI)</measure>
    <time_frame>8 weeks</time_frame>
    <description>The FDI assesses functional disability (physical and psychosocial functional impairment) in children and adolescents with chronic pain. Scores range from 0-60, with higher scores indicating greater functional disability, categorized as No/Minimal (0-12), Moderate (13-29), and Severe (30) Disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Juvenile Revised Fibromyalgia/Symptom Impact Questionnaire (FIQR/SIQR)</measure>
    <time_frame>8 weeks</time_frame>
    <description>The FIQR-C (and analogue SIQR) is a pediatric version of the adult Revised Fibromyalgia Impact Questionnaire that has been the major physical function assessment in adult fibromyalgia trials. The FIQR has credible construct validity, reliable test-retest characteristics and good sensitivity in demonstrating therapeutic change. The FIQR-C is used to measure subjects' physical function, overall impact of the syndrome, and symptom severity. It is scored from 0 (best) to 100 (worst) and takes less than 2 minutes to complete.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Quality of Life Inventory (PedsQL) 4.0 (Adolescent Form)</measure>
    <time_frame>8 weeks</time_frame>
    <description>PedsQL 4.0 (Pediatric Quality of Life Inventory) is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules. The PedsQL 4.0 Generic Core Scales consist of 23 items applicable for healthy school and community populations, as well as pediatric populations with acute and chronic health conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>8 weeks</time_frame>
    <description>The PSS is a 14-item scale that assesses perceived stress of life situations in adolescents and adults. Items are scored on a 5-point scale (0=never to 4=very often). Higher total scores indicate greater levels of perceived stress. The PSS has well-established validity in relation to physiological stress responses, anxiety, and depressive disorders.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Fibromyalgia</condition>
  <condition>Chronic Widespread Pain</condition>
  <arm_group>
    <arm_group_label>Mindfulness Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These adolescents will be invited to participate in a group mindfulness meditation program based on a protocol refined by the investigative team. The weekly group meetings will be taught by an MBSR teacher at the Yale School of Medicine, with experience teaching mindfulness interventions to adults, children, and adolescents.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Group</intervention_name>
    <description>Participants will attend weekly 1-2-hour group sessions (of 6-8 persons) led by a trained expert based on the working MBSR protocol. The weekly sessions will be scheduled in a time mutually convenient for participants and their parent/guardian that will accompany them to each group session. The MBSR group sessions will take place at the Yale School of Medicine.</description>
    <arm_group_label>Mindfulness Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  2010 American College of Rheumatology (ACR) criteria based on the Widespread Pain&#xD;
             Index (WPI) and Symptom Severity (SS) checklist.&#xD;
&#xD;
          -  Functional Disability Score ≥13 indicating at least moderate disability&#xD;
&#xD;
          -  Average pain intensity in the past week ≥ 4 on a 0-10 cm Visual Analog Scale.&#xD;
&#xD;
          -  Access to mobile telephone/smartphone with text messaging plan in order to receive&#xD;
             survey questions.&#xD;
&#xD;
          -  Chronic symptoms such as fatigue, pain, bowel dysfunction, perceived cognitive&#xD;
             impairment, or other non-specific symptoms persisting for 3-months or more, severe&#xD;
             enough to have led to more than one visit to a medical provider. These symptoms must&#xD;
             have not been found to be due to a definable general medical disorder despite adequate&#xD;
             evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of an autoimmune or rheumatologic disease&#xD;
&#xD;
          -  Current regular mindfulness meditation activity&#xD;
&#xD;
          -  Serious illness (including mental illness/psychopathology) within 90 days prior to&#xD;
             screening&#xD;
&#xD;
          -  Inability or unwillingness of a parent to give consent/permission or child to assent&#xD;
&#xD;
          -  Current use of opioid analgesics&#xD;
&#xD;
          -  Current prescription for antidepressant medications&#xD;
&#xD;
          -  Screening positive on the Columbia Suicide Screen (CSS)&#xD;
&#xD;
          -  Active participation (weekly or more often) in a fibromyalgia or chronic disease&#xD;
             support group&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ather Ali, ND, MPH, MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Ali A, Weiss TR, Dutton A, McKee D, Jones KD, Kashikar-Zuck S, Silverman WK, Shapiro ED. Mindfulness-Based Stress Reduction for Adolescents with Functional Somatic Syndromes: A Pilot Cohort Study. J Pediatr. 2017 Apr;183:184-190. doi: 10.1016/j.jpeds.2016.12.053. Epub 2017 Jan 12.</citation>
    <PMID>28088398</PMID>
  </results_reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>March 2, 2017</last_update_submitted>
  <last_update_submitted_qc>March 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fibromyalgia</keyword>
  <keyword>juvenile fibromyalgia</keyword>
  <keyword>juvenile primary fibromyalgia syndrome (JPFS)</keyword>
  <keyword>adolescent pain</keyword>
  <keyword>mindfulness</keyword>
  <keyword>MBSR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT02190474
org study id: 1201009502
secondary id: K23AT006703
nct id: NCT02190474
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The primary objective of this study to determine the feasibility and acceptability of a
      mindfulness intervention for adolescents with juvenile fibromyalgia/ chronic widespread pain
      and other similar chronic symptoms.
The primary objective is to test the feasibility, safety, tolerability and acceptability of a
      mindfulness meditation intervention for adolescents with juvenile fibromyalgia/chronic
      widespread pain.

      The purpose of the program is to test how effective an 8-week meditation and stress reduction
      class is in helping adolescents with chronic symptoms (including but not limited to
      fibromyalgia or chronic widespread pain, irritable bowel syndrome, joint pain, chronic
      fatigue, and others).

      Participants will attend group sessions led by an instructor experienced in MBSR in an
      academic setting. The mindfulness meditation group sessions will take place at the Yale
      School of Medicine.

      Participants will attend 90-minute weekly group sessions and a 4-hour retreat with
      approximately 6-8 other study participants at Yale School of Medicine. Participants are asked
      to practice at home by listening to pre-recorded 15-20 minute guided meditations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility and retention
time frame: 8 weeks
description: Feasibility and retention will be assessed after each cohort completes the group sessions. Feasibility of the intervention will be assessed by the proportion of eligible patients approached for the study who consent to participate and the proportion of the weekly sessions that are attended.
measure: Program Adherence
time frame: 8 weeks
description: Program adherence will be tracked by assessing the actual amount of home practice in minutes per week using weekly self-report diaries.
measure: Program Use
time frame: 8 weeks
description: Program use will be assessed by quantifying the amount of minutes that participants spent practicing MBSR. Participants will agree to receive and respond to a daily question of "How many minutes did you spend practicing MBSR yesterday" delivered by SMS/text message to their mobile telephone.
measure: Program Practicality
time frame: 8 weeks
description: Program practicality will be qualitatively assessed. Practicality (ability to attend intervention sessions and practice at home), interest in the intervention, perceived effectiveness, will be collected through brief (15-20 min) interviews following completion of the 8-week intervention.
measure: Functional Disability Inventory (FDI)
time frame: 8 weeks
description: The FDI assesses functional disability (physical and psychosocial functional impairment) in children and adolescents with chronic pain. Scores range from 0-60, with higher scores indicating greater functional disability, categorized as No/Minimal (0-12), Moderate (13-29), and Severe (30) Disability.
measure: Juvenile Revised Fibromyalgia/Symptom Impact Questionnaire (FIQR/SIQR)
time frame: 8 weeks
description: The FIQR-C (and analogue SIQR) is a pediatric version of the adult Revised Fibromyalgia Impact Questionnaire that has been the major physical function assessment in adult fibromyalgia trials. The FIQR has credible construct validity, reliable test-retest characteristics and good sensitivity in demonstrating therapeutic change. The FIQR-C is used to measure subjects' physical function, overall impact of the syndrome, and symptom severity. It is scored from 0 (best) to 100 (worst) and takes less than 2 minutes to complete.
measure: Pediatric Quality of Life Inventory (PedsQL) 4.0 (Adolescent Form)
time frame: 8 weeks
description: PedsQL 4.0 (Pediatric Quality of Life Inventory) is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules. The PedsQL 4.0 Generic Core Scales consist of 23 items applicable for healthy school and community populations, as well as pediatric populations with acute and chronic health conditions.
measure: Perceived Stress Scale (PSS)
time frame: 8 weeks
description: The PSS is a 14-item scale that assesses perceived stress of life situations in adolescents and adults. Items are scored on a 5-point scale (0=never to 4=very often). Higher total scores indicate greater levels of perceived stress. The PSS has well-established validity in relation to physiological stress responses, anxiety, and depressive disorders.
arm group label: Mindfulness Group
arm group type: Experimental
description: These adolescents will be invited to participate in a group mindfulness meditation program based on a protocol refined by the investigative team. The weekly group meetings will be taught by an MBSR teacher at the Yale School of Medicine, with experience teaching mindfulness interventions to adults, children, and adolescents.
intervention type: Behavioral
intervention name: Mindfulness Group
description: Participants will attend weekly 1-2-hour group sessions (of 6-8 persons) led by a trained expert based on the working MBSR protocol. The weekly sessions will be scheduled in a time mutually convenient for participants and their parent/guardian that will accompany them to each group session. The MBSR group sessions will take place at the Yale School of Medicine.
arm group label: Mindfulness Group
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Ather Ali, ND, MPH, MHS
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
citation: Ali A, Weiss TR, Dutton A, McKee D, Jones KD, Kashikar-Zuck S, Silverman WK, Shapiro ED. Mindfulness-Based Stress Reduction for Adolescents with Functional Somatic Syndromes: A Pilot Cohort Study. J Pediatr. 2017 Apr;183:184-190. doi: 10.1016/j.jpeds.2016.12.053. Epub 2017 Jan 12.
PMID: 28088398
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Chronic Pain