Mindfulness-based Cognitive Therapy and Cognitive Behavioral Therapy for Chronic Pain in Multiple Sclerosis

Status unknownNot a drug-phase studyMS (type not specified)NCT03782246

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • MBCT
  • CBT

What it measured

Main measures

  • Change in average pain intensity

    Baseline to 10 weeks (posttreatment; primary endpoint)

    Pain

Other measures (9)

  • Pain interference

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

    Pain
  • Average pain intensity - maintenance

    36 weeks (6-month follow up)

    Pain
  • Depressive symptom severity

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

    Mood and sleep
  • Patient ratings of global improvement & satisfaction

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

    Quality of life (reported by participants)
  • Fatigue severity

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

    Fatigue
  • Sleep disturbance

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

    Mood and sleep
  • Self-efficacy

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

    Pain
  • Physical Function

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

  • Global Quality of LIfe

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

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion 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 three months duration, with pain reportedly present > half the days in the past three 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 with video capabilities (any operating system) and internet access. Exclusion criteria are: 1. severe cognitive impairment; 2. currently in psychotherapy for pain > once a month; and 3. previously participated in a pain study that used CBT or MBCT.

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Nov 2018

    2. Main results due

      Aug 2022

    3. Finished

      Aug 2022

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