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MBCT and CBT for Chronic Pain in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03782246
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Dawn Ehde, University of Washington

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: MBCT Behavioral: CBT Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-based Cognitive Therapy and Cognitive Behavioral Therapy for Chronic Pain in Multiple Sclerosis
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Usual Care
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.
Experimental: Mindfulness-Based Cognitive Therapy (MBCT)
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.
 Behavioral: MBCT
Mindfulness- based Cognitive Therapy
Experimental: Cognitive Behavioral Therapy (CBT)
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.
 Behavioral: CBT
Cognitive Behavioral Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Change in average pain intensity [ Time Frame: Baseline to 10 weeks (posttreatment; primary endpoint) ]
    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.


Secondary Outcome Measures :
  1. Pain interference [ Time Frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up) ]
    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.

  2. Average pain intensity - maintenance [ Time Frame: 36 weeks (6-month follow up) ]
    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)

  3. Depressive symptom severity [ Time Frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up) ]
    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.

  4. Patient ratings of global improvement & satisfaction [ Time Frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up) ]
    5-point Likert scales of patient global change, treatment helpfulness, & satisfaction. Higher numbers indicate more satisfaction with and improvements from treatment.

  5. Fatigue severity [ Time Frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up) ]
    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.

  6. Sleep disturbance [ Time Frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up) ]
    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.

  7. Self-efficacy [ Time Frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up) ]
    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.

  8. Physical Function [ Time Frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up) ]
    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.

  9. Global Quality of LIfe [ Time Frame: baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up) ]
    Global QOL Scale- one question asking about quality of life. Higher numbers indicate higher quality of life


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria are:

  1. 18 years of age or older;
  2. a diagnosis of clinically definite MS confirmed by participant's provider;
  3. the presence of chronic pain, defined as average pain intensity in the past week of at least moderate severity (defined as a ≥3 on the 0-10 numerical rating scale) and pain of at least six months duration, with pain reportedly present > half the days in the past six months;
  4. reads and speaks English;
  5. has access and is able to communicate over the telephone; and (6) has a computer or digital device (any operating system) with internet access.

Exclusion criteria are:

  1. severe cognitive impairment;
  2. currently in psychotherapy > once a month; and
  3. previously participated in a pain study that used CBT or MBCT.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782246


Contacts
Contact: University of Washington MS Center 855-320-8230 msadapt@uw.edu

Locations
United States, Washington
UW Medicine Multiple Sclerosis Center Recruiting
Seattle, Washington, United States, 98195
Contact: Makena Kaylor    206-598-8201    mkaylor@uw.edu   
Principal Investigator: Dawn M Ehde, PhD         
Sponsors and Collaborators
University of Washington
National Multiple Sclerosis Society
Investigators
Principal Investigator: Dawn Ehde, PhD University of Washington
More Information
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Publications:

Responsible Party: Dawn Ehde, Professor, School of Medicine: Rehabilitation Medicine:Psychology, University of Washington
ClinicalTrials.gov Identifier: NCT03782246     History of Changes
Other Study ID Numbers: STUDY00004422
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dawn Ehde, University of Washington:
chronic pain
multiple sclerosis
pain
mindfulness
cognitive behavioral therapy

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Chronic Pain
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms