MBCT and CBT for Chronic Pain in Multiple Sclerosis

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.

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.