Mindfulness Based Stress Reduction in MS

CompletedNot a drug-phase studyEarly (CIS/RIS)NCT01419301

What it found

No results found

We found no results in the registry or in papers.

This trial finished 13 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Mindfulness based stress reduction (MBSR)

What it measured

Main measures

  • Electronic measure of needle disposals (MEMS TrackCaps)

    Medication adherence will be measured by total number of missed doses, calculated from total needle disposals. The total number of missed doses across the six weeks will be compared between the two tr

    Quality of life (reported by participants)

Other measures (10)

  • Perceived Stress Scale-10

    Baseline, 1 X between weeks 3-7, Week 8

  • Holmes and Rahe Social Readjustment Rating Scale (SRRS

    Baseline, 1 X between weeks 3-7, Week 8

    Bladder, bowel and sexual function
  • Chicago Multiscale Depression Inventory (CMDI)

    Baseline, 1 X betweeen Weeks 3-7, Week 8

    Mood and sleep
  • State Trait Anxiety Inventory (STAI)

    Baseline, 1 X betweeen Weeks 3-7, Week 8

    Mood and sleep
  • Positive and Negative Affect Scale (PANAS)

    Baseline, 1 X between Weeks 3 - 7, Week 8

  • Fatigue Severity Scale (FSS)

    Baseline, 1 X between Weeks 3 - 7, Week 8

    Fatigue
  • MACFIMS neuropsychological battery

    Baseline and Week 8

    Disability progressionThinking and memory
  • Expanded Disability Status Scale (EDSS)

    Baseline and Week 8

    Disability progression
  • Physiologic Markers of Stress

    Baseline and Week 8

  • Physiologic Maker of Stress

    Baseline, 1 X between Week 3 - 7, Weeek 8

Who could take part

Early (CIS/RIS) · 18 to 70

Show the full criteria

Inclusion criteria

* Patients with either definite MS according to the revised McDonald criteria (Polman 2005) or patients with CIS (defined as an initial MS relapse with objective documentation and 2 or more lesions within the CNS of which at least one must involve the brain) * Patients on GA therapy for at least 6 months * Age 18 - 70

Exclusion criteria

* Unwilling to comply with study procedures * Use of other DMT in conjunction with GA * Unable to provide informed consent. * Current (past 30 days) substance abuse * Newly initiated (past 30 days) psychiatry treatment * Enrolled in another program of meditation in the past six months.

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

About this trial

In the sponsor's words

This study focuses on stress, cognition, mood and fatigue and its effect on medication compliance. Medication compliance is measured by the weight of discarded needles. The investigators will be administering neuropsychological testing at baseline and the final visit. The subjects will complete self-report assessments during their 8 weeks in the study. Group A will have additional weekly phone support for meditation, while Group B will have meditation training only.

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History

    1. Started

      May 2011

    2. Main results due

      Apr 2013

    3. Finished

      Nov 2014

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