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MBCT for Multiple Sclerosis

N/A

Waitlist Available

Led By Dawn Ehde, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Multiple Sclerosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), 10 weeks (posttreatment), and 36 weeks (6-month follow up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in average pain intensity

Secondary study objectives

Average pain intensity - maintenance

Depressive symptom severity

Fatigue severity

+6 more

Side effects data

From 2022 Phase 1 trial • 19 Patients • NCT04983680

Adverse Event

100%

80%

60%

40%

20%

Study treatment Arm

Mindfulness-Based Cognitive Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness-Based Cognitive Therapy (MBCT)Experimental Treatment1 Intervention

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.

Group II: Cognitive Behavioral Therapy (CBT)Experimental Treatment1 Intervention

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.

Group III: Usual CareActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBT

2013

Completed Phase 3

~4220

MBCT

2015

Completed Phase 1

~160