MBCT and CBT for Chronic Pain in Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT03782246 |
Recruitment Status :
Active, not recruiting
First Posted : December 20, 2018
Last Update Posted : April 18, 2022
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Condition or disease | Intervention/treatment | Phase |
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Multiple Sclerosis | Behavioral: MBCT Behavioral: CBT | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 273 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 |

Arm | Intervention/treatment |
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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.
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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.
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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.
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Behavioral: CBT
Cognitive Behavioral Therapy |
- 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.
- 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.
- 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)
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria are:
- 18 years of age or older;
- a diagnosis of clinically definite MS confirmed by participant's provider;
- 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 three months duration, with pain reportedly present > half the days in the past three months;
- reads and speaks English;
- has access and is able to communicate over the telephone; and
- has a computer or digital device with video capabilities (any operating system) and internet access.
Exclusion criteria are:
- severe cognitive impairment;
- currently in psychotherapy for pain > once a month; and
- previously participated in a pain study that used CBT or MBCT.

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
United States, Washington | |
UW Medicine Multiple Sclerosis Center | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | Dawn Ehde, PhD | University of Washington |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dawn Ehde, Professor, School of Medicine: Rehabilitation Medicine:Psychology, University of Washington |
ClinicalTrials.gov Identifier: | NCT03782246 |
Other Study ID Numbers: |
STUDY00004422 |
First Posted: | December 20, 2018 Key Record Dates |
Last Update Posted: | April 18, 2022 |
Last Verified: | April 2022 |
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 |
chronic pain multiple sclerosis pain mindfulness cognitive behavioral therapy |
Multiple Sclerosis 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 |