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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

Tracking Information
First Submitted Date  ICMJE December 5, 2018
First Posted Date  ICMJE December 20, 2018
Last Update Posted Date December 20, 2018
Actual Study Start Date  ICMJE November 28, 2018
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE MBCT and CBT for Chronic Pain in Multiple Sclerosis
Official Title  ICMJE Mindfulness-based Cognitive Therapy and Cognitive Behavioral Therapy for Chronic Pain in Multiple Sclerosis
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Behavioral: MBCT
    Mindfulness- based Cognitive Therapy
  • Behavioral: CBT
    Cognitive Behavioral Therapy
Study Arms
  • 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.
    Intervention: Behavioral: MBCT
  • 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.
    Intervention: Behavioral: CBT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 18, 2018)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date August 1, 2022
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: University of Washington MS Center 855-320-8230 msadapt@uw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03782246
Other Study ID Numbers  ICMJE STUDY00004422
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Dawn Ehde, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Multiple Sclerosis Society
Investigators  ICMJE
Principal Investigator: Dawn Ehde, PhD University of Washington
PRS Account University of Washington
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP