<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/NCT03782246</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00004422</org_study_id>
    <nct_id>NCT03782246</nct_id>
  </id_info>
  <brief_title>MBCT and CBT for Chronic Pain in Multiple Sclerosis</brief_title>
  <official_title>Mindfulness-based Cognitive Therapy and Cognitive Behavioral Therapy for Chronic Pain in Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Multiple Sclerosis Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic pain is one of the most prevalent, disabling and persistent symptoms affecting people&#xD;
      with multiple sclerosis (MS). Different nonpharmacological treatments are known to be&#xD;
      beneficial for managing pain, including cognitive behavioral therapy and mindfulness based&#xD;
      cognitive therapy. This study compares these two non-pharmacological approaches to pain&#xD;
      management in people with Multiple Sclerosis. The purpose of this study is to see if these&#xD;
      treatments can help decrease pain and other outcomes (e.g., sleep, fatigue) in persons with&#xD;
      Multiple Sclerosis. The study will determine who benefits from these treatments and if these&#xD;
      treatments can be given effectively by videoconference.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic pain is one of the most prevalent, disabling, and persistent symptoms associated with&#xD;
      multiple sclerosis (MS). Approximately 50 - 60% of adults with multiple sclerosis experience&#xD;
      moderate or severe, persistent pain. Medications rarely provide adequate pain relief and can&#xD;
      entail negative side-effects. As a result, individuals with Multiple Sclerosis have become&#xD;
      increasingly interested in nonpharmacologic approaches to pain management.&#xD;
&#xD;
      Previously completed clinical trials, and those of others, support the efficacy of&#xD;
      cognitive-behavioral therapy (CBT) for pain in people with Multiple Sclerosis.&#xD;
      Cognitive-behavioral therapy has been shown to decrease pain, decrease pain interference, and&#xD;
      improve mood, sleep, and fatigue. Mindfulness-based cognitive therapy (MBCT) is another&#xD;
      promising non-pharmacologic treatment that has been shown to improve pain outcomes in people&#xD;
      with chronic pain; mindfulness-based cognitive therapy may also benefit individuals with&#xD;
      Multiple Sclerosis and chronic pain. Although both of these treatments are effective pain&#xD;
      treatments, the investigators do not know if one is more effective for the other.&#xD;
      Furthermore, it is likely that there are both responders and non-responders to each of the&#xD;
      treatments. That is, for any individual, two different treatments such as&#xD;
      cognitive-behavioral therapy and mindfulness-based cognitive therapy may not necessarily be&#xD;
      similarly beneficial in addressing pain. There is an urgent need to understand variability in&#xD;
      responses across different psychosocial treatment interventions which will, in turn, lead to&#xD;
      more effective and better-targeted interventions for chronic pain in Multiple Sclerosis. In&#xD;
      other words, the investigators need to better understand for whom each of these pain&#xD;
      interventions work best. Such knowledge will lead to better patient-treatment matching and,&#xD;
      ultimately, better treatment outcomes.&#xD;
&#xD;
      This study is the first randomized controlled trial (RCT) comparing eight 2-hour sessions of&#xD;
      group video-conference delivered mindfulness-based cognitive therapy and cognitive-behavioral&#xD;
      therapy to usual care for chronic pain in 240 adults with Multiple Sclerosis. This study will&#xD;
      identify not only the unique benefits conferred by each these two treatments but also for&#xD;
      whom each treatment is most suitable. This study will address two specific aims:&#xD;
&#xD;
      Aim 1: To determine the efficacy of group-based, videoconference-delivered mindfulness-based&#xD;
      cognitive therapy and cognitive-behavioral therapy interventions, relative to usual care, in&#xD;
      reducing pain intensity (the primary outcome) in adults with chronic pain and Multiple&#xD;
      Sclerosis. Hypothesis 1: Primary Study Hypothesis: Participants randomly assigned to&#xD;
      mindfulness-based cognitive therapy or cognitive-behavioral therapy will report significantly&#xD;
      greater reductions in average pain intensity (primary outcome) relative to participants&#xD;
      assigned to usual care at post-treatment (12 weeks post randomization, primary endpoint).&#xD;
&#xD;
      Aim 2: To increase the ability to more effectively match patients to treatments by&#xD;
      identifying pain treatment moderators. Although on average similar outcomes are expected in&#xD;
      mindfulness-based cognitive therapy and cognitive-behavioral therapy, it is expected that&#xD;
      there will be individual differences in who responds to each treatment. Specifically, that&#xD;
      baseline mindfulness, behavioral activation, and pain catastrophizing will be associated with&#xD;
      treatment response for the active treatment arms. Thus, to address Aim 2, the investigators&#xD;
      will explore the ability of baseline mindfulness, behavioral activation, and pain&#xD;
      catastrophizing to predict response to mindfulness-based cognitive therapy and&#xD;
      cognitive-behavioral therapy. The investigators hypothesize that (1) baseline pain&#xD;
      catastrophizing will be positively associated with treatment response for the two active&#xD;
      treatment arms, but not the usual care condition (Hypothesis 2a); (2) baseline behavioral&#xD;
      activation will be positively associated with treatment response for the two active treatment&#xD;
      arms, but not the usual care condition (Hypothesis 2b), and (3) baseline mindfulness will be&#xD;
      positively associated with treatment response to mindfulness-based cognitive therapy but not&#xD;
      to either cognitive-behavioral therapy or the usual care condition (Hypothesis 2c).&#xD;
&#xD;
      In addition to testing the above specific hypotheses, the investigators will explore: (1) the&#xD;
      effects of mindfulness-based cognitive therapy and cognitive-behavioral therapy relative to&#xD;
      each other on both the primary (i.e., change in average pain intensity) and secondary&#xD;
      outcomes (pain interference and key co-morbid symptoms including fatigue, sleep, and&#xD;
      depressive symptoms), as Hypothesis 1 pertains only to the effects of cognitive-behavioral&#xD;
      therapy and mindfulness-based cognitive therapy relative to the usual care control, not to&#xD;
      each other; (2) the relative effects of all three treatment conditions on the secondary&#xD;
      outcomes; (3) the maintenance, loss or gain in any treatment effects at 6-months&#xD;
      post-treatment; (4) dose effects; and (5) additional potential moderators of outcome,&#xD;
      including demographics, baseline pain and disease characteristics (e.g., pain severity, pain&#xD;
      type, disease severity) and baseline depressive symptom severity and fatigue.&#xD;
&#xD;
      Impact. As the first RCT evaluating the efficacy of mindfulness-based cognitive therapy&#xD;
      relative to cognitive-behavioral therapy for chronic pain in adults with Multiple Sclerosis,&#xD;
      study findings will provide critical information about the relative benefits of both&#xD;
      mindfulness-based cognitive therapy and cognitive-behavioral therapy compared to one another&#xD;
      and to usual care. This will determine the value of both of these approaches as adjunctive&#xD;
      pain management tools, and if results support the use of mindfulness-based cognitive therapy,&#xD;
      this will expand the currently available treatment options for people with Multiple&#xD;
      Sclerosis. Remote intervention delivery using video-conference technology may improve the&#xD;
      reach of these nonpharmacologic interventions, transcending geographical, transportation, and&#xD;
      other access barriers. In addition, the investigators anticipate that increased knowledge&#xD;
      concerning patient characteristics associated with response to treatment (i.e., treatment&#xD;
      effect moderators) may improve treatment efficacy by better matching patients to the most&#xD;
      appropriate treatments. All of these findings will contribute to our long-term goal of&#xD;
      increasing the availability and efficacy of chronic pain treatments for individuals with&#xD;
      Multiple Sclerosis and chronic pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 28, 2018</start_date>
  <completion_date type="Anticipated">August 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2022</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in average pain intensity</measure>
    <time_frame>Baseline to 10 weeks (posttreatment; primary endpoint)</time_frame>
    <description>0-10 Numerical Pain Scale of average pain intensity in past week (0 = no pain, 10 = worst pain imaginable). Higher scores indicate higher levels of self-reported pain intensity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain interference</measure>
    <time_frame>baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)</time_frame>
    <description>Brief Pain Inventory -Interference scale (modified version for MS) Questions ask how much pain has interfered with various activities on a 0-10 scale where 0 is no interference and 10 is complete interference. All questions are averaged and lower scores indicate lower interference from pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average pain intensity - maintenance</measure>
    <time_frame>36 weeks (6-month follow up)</time_frame>
    <description>0-10 Numerical Pain Scale of average pain intensity in past week (0 = no pain, 10 = worst pain imaginable). Higher scores indicate higher levels of self-reported pain intensity. We will examine whether any improvements in average pain intensity are maintained at 36 weeks (6-month follow up)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptom severity</measure>
    <time_frame>baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)</time_frame>
    <description>Patient Health Questionnaire 9 which measures depressive symptom severity. The questions are summed to assess levels of depressive symptom severity. Lower scores indicate lower depressive symptoms/severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient ratings of global improvement &amp; satisfaction</measure>
    <time_frame>baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)</time_frame>
    <description>5-point Likert scales of patient global change, treatment helpfulness, &amp; satisfaction. Higher numbers indicate more satisfaction with and improvements from treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue severity</measure>
    <time_frame>baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)</time_frame>
    <description>Modified Fatigue Impact Scale which asks 24 questions about fatigue severity in the past 4 weeks. 0=never and 4=almost always. Scores are averaged and lower scores indicate lower fatigue severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep disturbance</measure>
    <time_frame>baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)</time_frame>
    <description>PROMIS Sleep Disturbance scale- 4 questions asking about sleep quality in the past week. Scores are averaged. Higher scores indicate higher self-reported levels of sleep disturbance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)</time_frame>
    <description>UW Pain Self-Efficacy Scale-6 questions assessing confidence people have in managing their pain. Scores are averaged (1=not at all-5=very much) higher scores indicate higher self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Function</measure>
    <time_frame>baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)</time_frame>
    <description>PROMIS_29 4 Item version 4 questions assessing ability to do various activities. Ratings range from 5=without any difficulty to 1=unable to do. Higher scores indicate more levels of physical functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Quality of LIfe</measure>
    <time_frame>baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)</time_frame>
    <description>Global QOL Scale- one question asking about quality of life. Higher numbers indicate higher quality of life</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">273</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention, participant will continue their usual care for pain and MS. We will collect information about what treatments are used by the usual care participants. They will be offered the opportunity to participate in one of the two active study treatments (MBCT or CBT) after completion of the 6-month followup.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness-Based Cognitive Therapy (MBCT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will attend eight, 2-hour group treatment MBCT sessions delivered using free video-conferencing technology. Groups will consist of 6-8 people who also have MS and chronic pain. Participants will be asked to practice skills learned in session between sessions. MBCT integrates mindfulness meditation practices within a CBT-oriented framework to address not only unhelpful pain cognitions and behaviors but also attentional control, decoupling of attention from emotion, mindful cognitions, and meditative behavior.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy (CBT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will attend eight, 2-hour group treatment CBT sessions delivered using free video-conferencing technology. Groups will consist of 6-8 people who also have MS and chronic pain. Participants will be asked to practice skills learned in session between sessions. CBT focuses on increasing adaptive pain coping strategies and reducing unhelpful thoughts and behaviors related to pain. Strategies include relaxation techniques, goal-setting, activity pacing, and changing unhelpful thinking patterns.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MBCT</intervention_name>
    <description>Mindfulness- based Cognitive Therapy</description>
    <arm_group_label>Mindfulness-Based Cognitive Therapy (MBCT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT</intervention_name>
    <description>Cognitive Behavioral Therapy</description>
    <arm_group_label>Cognitive Behavioral Therapy (CBT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria are:&#xD;
&#xD;
          1. 18 years of age or older;&#xD;
&#xD;
          2. a diagnosis of clinically definite MS confirmed by participant's provider;&#xD;
&#xD;
          3. the presence of chronic pain, defined as average pain intensity in the past week of at&#xD;
             least moderate severity (defined as a ≥3 on the 0-10 numerical rating scale) and pain&#xD;
             of at least three months duration, with pain reportedly present &gt; half the days in the&#xD;
             past three months;&#xD;
&#xD;
          4. reads and speaks English;&#xD;
&#xD;
          5. has access and is able to communicate over the telephone; and&#xD;
&#xD;
          6. has a computer or digital device with video capabilities (any operating system) and&#xD;
             internet access.&#xD;
&#xD;
        Exclusion criteria are:&#xD;
&#xD;
          1. severe cognitive impairment;&#xD;
&#xD;
          2. currently in psychotherapy for pain &gt; once a month; and&#xD;
&#xD;
          3. previously participated in a pain study that used CBT or MBCT.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dawn Ehde, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UW Medicine Multiple Sclerosis Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Dawn Ehde</investigator_full_name>
    <investigator_title>Professor, School of Medicine: Rehabilitation Medicine:Psychology</investigator_title>
  </responsible_party>
  <keyword>chronic pain</keyword>
  <keyword>multiple sclerosis</keyword>
  <keyword>pain</keyword>
  <keyword>mindfulness</keyword>
  <keyword>cognitive behavioral therapy</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>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03782246
org study id: STUDY00004422
nct id: NCT03782246
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Chronic pain is one of the most prevalent, disabling and persistent symptoms affecting people
      with multiple sclerosis (MS). Different nonpharmacological treatments are known to be
      beneficial for managing pain, including cognitive behavioral therapy and mindfulness based
      cognitive therapy. This study compares these two non-pharmacological approaches to pain
      management in people with Multiple Sclerosis. The purpose of this study is to see if these
      treatments can help decrease pain and other outcomes (e.g., sleep, fatigue) in persons with
      Multiple Sclerosis. The study will determine who benefits from these treatments and if these
      treatments can be given effectively by videoconference.
Chronic pain is one of the most prevalent, disabling, and persistent symptoms associated with
      multiple sclerosis (MS). Approximately 50 - 60% of adults with multiple sclerosis experience
      moderate or severe, persistent pain. Medications rarely provide adequate pain relief and can
      entail negative side-effects. As a result, individuals with Multiple Sclerosis have become
      increasingly interested in nonpharmacologic approaches to pain management.

      Previously completed clinical trials, and those of others, support the efficacy of
      cognitive-behavioral therapy (CBT) for pain in people with Multiple Sclerosis.
      Cognitive-behavioral therapy has been shown to decrease pain, decrease pain interference, and
      improve mood, sleep, and fatigue. Mindfulness-based cognitive therapy (MBCT) is another
      promising non-pharmacologic treatment that has been shown to improve pain outcomes in people
      with chronic pain; mindfulness-based cognitive therapy may also benefit individuals with
      Multiple Sclerosis and chronic pain. Although both of these treatments are effective pain
      treatments, the investigators do not know if one is more effective for the other.
      Furthermore, it is likely that there are both responders and non-responders to each of the
      treatments. That is, for any individual, two different treatments such as
      cognitive-behavioral therapy and mindfulness-based cognitive therapy may not necessarily be
      similarly beneficial in addressing pain. There is an urgent need to understand variability in
      responses across different psychosocial treatment interventions which will, in turn, lead to
      more effective and better-targeted interventions for chronic pain in Multiple Sclerosis. In
      other words, the investigators need to better understand for whom each of these pain
      interventions work best. Such knowledge will lead to better patient-treatment matching and,
      ultimately, better treatment outcomes.

      This study is the first randomized controlled trial (RCT) comparing eight 2-hour sessions of
      group video-conference delivered mindfulness-based cognitive therapy and cognitive-behavioral
      therapy to usual care for chronic pain in 240 adults with Multiple Sclerosis. This study will
      identify not only the unique benefits conferred by each these two treatments but also for
      whom each treatment is most suitable. This study will address two specific aims:

      Aim 1: To determine the efficacy of group-based, videoconference-delivered mindfulness-based
      cognitive therapy and cognitive-behavioral therapy interventions, relative to usual care, in
      reducing pain intensity (the primary outcome) in adults with chronic pain and Multiple
      Sclerosis. Hypothesis 1: Primary Study Hypothesis: Participants randomly assigned to
      mindfulness-based cognitive therapy or cognitive-behavioral therapy will report significantly
      greater reductions in average pain intensity (primary outcome) relative to participants
      assigned to usual care at post-treatment (12 weeks post randomization, primary endpoint).

      Aim 2: To increase the ability to more effectively match patients to treatments by
      identifying pain treatment moderators. Although on average similar outcomes are expected in
      mindfulness-based cognitive therapy and cognitive-behavioral therapy, it is expected that
      there will be individual differences in who responds to each treatment. Specifically, that
      baseline mindfulness, behavioral activation, and pain catastrophizing will be associated with
      treatment response for the active treatment arms. Thus, to address Aim 2, the investigators
      will explore the ability of baseline mindfulness, behavioral activation, and pain
      catastrophizing to predict response to mindfulness-based cognitive therapy and
      cognitive-behavioral therapy. The investigators hypothesize that (1) baseline pain
      catastrophizing will be positively associated with treatment response for the two active
      treatment arms, but not the usual care condition (Hypothesis 2a); (2) baseline behavioral
      activation will be positively associated with treatment response for the two active treatment
      arms, but not the usual care condition (Hypothesis 2b), and (3) baseline mindfulness will be
      positively associated with treatment response to mindfulness-based cognitive therapy but not
      to either cognitive-behavioral therapy or the usual care condition (Hypothesis 2c).

      In addition to testing the above specific hypotheses, the investigators will explore: (1) the
      effects of mindfulness-based cognitive therapy and cognitive-behavioral therapy relative to
      each other on both the primary (i.e., change in average pain intensity) and secondary
      outcomes (pain interference and key co-morbid symptoms including fatigue, sleep, and
      depressive symptoms), as Hypothesis 1 pertains only to the effects of cognitive-behavioral
      therapy and mindfulness-based cognitive therapy relative to the usual care control, not to
      each other; (2) the relative effects of all three treatment conditions on the secondary
      outcomes; (3) the maintenance, loss or gain in any treatment effects at 6-months
      post-treatment; (4) dose effects; and (5) additional potential moderators of outcome,
      including demographics, baseline pain and disease characteristics (e.g., pain severity, pain
      type, disease severity) and baseline depressive symptom severity and fatigue.

      Impact. As the first RCT evaluating the efficacy of mindfulness-based cognitive therapy
      relative to cognitive-behavioral therapy for chronic pain in adults with Multiple Sclerosis,
      study findings will provide critical information about the relative benefits of both
      mindfulness-based cognitive therapy and cognitive-behavioral therapy compared to one another
      and to usual care. This will determine the value of both of these approaches as adjunctive
      pain management tools, and if results support the use of mindfulness-based cognitive therapy,
      this will expand the currently available treatment options for people with Multiple
      Sclerosis. Remote intervention delivery using video-conference technology may improve the
      reach of these nonpharmacologic interventions, transcending geographical, transportation, and
      other access barriers. In addition, the investigators anticipate that increased knowledge
      concerning patient characteristics associated with response to treatment (i.e., treatment
      effect moderators) may improve treatment efficacy by better matching patients to the most
      appropriate treatments. All of these findings will contribute to our long-term goal of
      increasing the availability and efficacy of chronic pain treatments for individuals with
      Multiple Sclerosis and chronic pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in average pain intensity
time frame: Baseline to 10 weeks (posttreatment; primary endpoint)
description: 0-10 Numerical Pain Scale of average pain intensity in past week (0 = no pain, 10 = worst pain imaginable). Higher scores indicate higher levels of self-reported pain intensity.
measure: Pain interference
time frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)
description: Brief Pain Inventory -Interference scale (modified version for MS) Questions ask how much pain has interfered with various activities on a 0-10 scale where 0 is no interference and 10 is complete interference. All questions are averaged and lower scores indicate lower interference from pain.
measure: Average pain intensity - maintenance
time frame: 36 weeks (6-month follow up)
description: 0-10 Numerical Pain Scale of average pain intensity in past week (0 = no pain, 10 = worst pain imaginable). Higher scores indicate higher levels of self-reported pain intensity. We will examine whether any improvements in average pain intensity are maintained at 36 weeks (6-month follow up)
measure: Depressive symptom severity
time frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)
description: Patient Health Questionnaire 9 which measures depressive symptom severity. The questions are summed to assess levels of depressive symptom severity. Lower scores indicate lower depressive symptoms/severity.
measure: Patient ratings of global improvement & satisfaction
time frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)
description: 5-point Likert scales of patient global change, treatment helpfulness, & satisfaction. Higher numbers indicate more satisfaction with and improvements from treatment.
measure: Fatigue severity
time frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)
description: Modified Fatigue Impact Scale which asks 24 questions about fatigue severity in the past 4 weeks. 0=never and 4=almost always. Scores are averaged and lower scores indicate lower fatigue severity.
measure: Sleep disturbance
time frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)
description: PROMIS Sleep Disturbance scale- 4 questions asking about sleep quality in the past week. Scores are averaged. Higher scores indicate higher self-reported levels of sleep disturbance.
measure: Self-efficacy
time frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)
description: UW Pain Self-Efficacy Scale-6 questions assessing confidence people have in managing their pain. Scores are averaged (1=not at all-5=very much) higher scores indicate higher self-efficacy.
measure: Physical Function
time frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)
description: PROMIS_29 4 Item version 4 questions assessing ability to do various activities. Ratings range from 5=without any difficulty to 1=unable to do. Higher scores indicate more levels of physical functioning.
measure: Global Quality of LIfe
time frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)
description: Global QOL Scale- one question asking about quality of life. Higher numbers indicate higher quality of life
arm group label: Usual Care
arm group type: No Intervention
description: No intervention, participant will continue their usual care for pain and MS. We will collect information about what treatments are used by the usual care participants. They will be offered the opportunity to participate in one of the two active study treatments (MBCT or CBT) after completion of the 6-month followup.
arm group label: Mindfulness-Based Cognitive Therapy (MBCT)
arm group type: Experimental
description: Participants will attend eight, 2-hour group treatment MBCT sessions delivered using free video-conferencing technology. Groups will consist of 6-8 people who also have MS and chronic pain. Participants will be asked to practice skills learned in session between sessions. MBCT integrates mindfulness meditation practices within a CBT-oriented framework to address not only unhelpful pain cognitions and behaviors but also attentional control, decoupling of attention from emotion, mindful cognitions, and meditative behavior.
arm group label: Cognitive Behavioral Therapy (CBT)
arm group type: Experimental
description: Participants will attend eight, 2-hour group treatment CBT sessions delivered using free video-conferencing technology. Groups will consist of 6-8 people who also have MS and chronic pain. Participants will be asked to practice skills learned in session between sessions. CBT focuses on increasing adaptive pain coping strategies and reducing unhelpful thoughts and behaviors related to pain. Strategies include relaxation techniques, goal-setting, activity pacing, and changing unhelpful thinking patterns.
intervention type: Behavioral
intervention name: MBCT
description: Mindfulness- based Cognitive Therapy
arm group label: Mindfulness-Based Cognitive Therapy (MBCT)
intervention type: Behavioral
intervention name: CBT
description: Cognitive Behavioral Therapy
arm group label: Cognitive Behavioral Therapy (CBT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dawn Ehde, PhD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Dawn Ehde
investigator title: Professor, School of Medicine: Rehabilitation Medicine:Psychology
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Chronic Pain
sharing ipd: Undecided