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Multiple SclerosisPhase 1/2NCT02012439

Comparison of the Efficacy and Mechanisms for MBCT and CT for Multiple Sclerosis (MS) Chronic Pain

A Phase 1/2 study testing Mindfulness Based Cognitive Therapy and Cognitive Therapy in people with Multiple Sclerosis, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic pain is a pervasive, serious problem for many individuals with multiple sclerosis (MS) that is typically inadequately treated by medications alone. There is a critical need to develop and evaluate innovative psychosocial interventions that have the capacity to effectively target the multidimensional nature of… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Mindfulness Based Cognitive Therapy and Cognitive Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Oct 2013to Dec 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of MS obtained by ICD coding list
  • At least 6 months post-diagnosis.
  • At least 18 years old.
  • Read, speak and understand English.
  • Experience chronic pain on a daily basis.
  • Most significant pain problem(s) is or are related to MS.
Show all 10Show fewer
  • Report an average pain intensity of at least 4 on a 0-10 Numerical Scale in the past week.
  • Most significant pain problem(s) has or have lasted at least six months.
  • Experience ongoing pain with an average intensity of 4 or more on a 0-10 scale when they experience pain.*
  • Have internet access on a daily basis.

Who cannot join

  • 1. Psychiatric condition or symptoms that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UW Medicine Multiple Sclerosis Center

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: The Efficacy and Mechanisms of Cognitive Therapy Compared to Mindfulness-Based Cognitive Therapy in Multiple Sclerosis (MS) Pain

Chronic pain is a pervasive, serious problem for many individuals with multiple sclerosis (MS) that is typically inadequately treated by medications alone. There is a critical need to develop and evaluate innovative psychosocial interventions that have the capacity to effectively target the multidimensional nature of MS pain. Cognitive Therapy (CT) is one psychosocial treatment that has been found to be a potentially beneficial treatment for chronic MS pain. This approach teaches patients to identify and replace unhelpful thoughts about pain with helpful, more adaptive thoughts. In addition, over the past decade there has been a steady upsurge of research examining mindfulness meditation-based therapies for the treatment of medical conditions, including symptoms associated with MS. Mindfulness mediation involves training the mind to disengage from automatic thinking patterns to mindfully perceive, in a non-judgmental manner, one's moment-to-moment experiences. This meditation technique teaches patients to become aware of thoughts, emotions, and physical sensations and to recognize that these are transient experiences that can be mindfully perceived, accepted and let go. A promising, more recent trend in treatment development research is the integration of tradition CT with mindfulness-based meditation, an approach referred to as Mindfulness-Based Cognitive Therapy (MBCT). To date, we are the only research group that has adapted and tested a manualized MBCT approach for the treatment of painful medical conditions. Thus, the proposed pilot randomized controlled trial aims to utilize state-of-the-art research methodology to evaluate traditional Cognitive Therapy (CT) compared to an innovative, newly developed Mindfulness-Based Cognitive Therapy (MBCT) protocol for the treatment of chronic pain in individuals with multiple sclerosis. This study will answer three primary questions: (1) Do these treatments work to improve chronic pain for individuals with MS and do these treatment also improve associated symptoms such as depression, fatigue, and engagement in daily activities?; (2) How do these treatments work in individuals with MS, i.e., what factors underlie improvement in outcomes during treatment?; and (3) What are the individual person characteristics that best predict outcome? This will be the first study to examine MBCT within an MS population. The results will lead to the emergence of a novel, much needed additional psychosocial treatment option for patients with chronic MS pain.

Being tested
Mindfulness Based Cognitive Therapy, Cognitive Therapy
Keywords
multiple sclerosis, chronic pain, treatment, nonpharmacological, mindfulness, cognitive therapy
Medical subject headings
Multiple Sclerosis, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Based Cognitive TherapyBehavioural

  • Cognitive TherapyBehavioural

Study groups in NCT02012439
Study groupRoleWhat they receive
Mindfulness Based Cognitive TherapyActive comparatorMindfulness Based Cognitive Therapy
Receives: Behavioral: Mindfulness Based Cognitive Therapy
Cognitive therapyActive comparatorCognitive Therapy
Receives: Behavioral: Cognitive Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain intensity

    numeric rating scale (0-10 scale)

    Measured: at post-treatment (5 weeks on average)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionApr 2015
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02012439
Sponsor's protocol ID
45416
Status last verified
Sep 2019
First submitted
22 Oct 2013
Last updated
16 Sep 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mindfulness Based Cognitive Therapy and Cognitive Therapy in people with Multiple Sclerosis, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain intensity (time frame: at post-treatment (5 weeks on average)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.

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