A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT03949296

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

  • Mindfulness Intervention

Placebo

  • Sleep Hygiene

What it measured

Main measures

  • Sleep Quality

    4 months

    Mood and sleep

Other measures (2)

  • Self-Reported Sleep Quality

    4 months

    Myelin repairMood and sleep
  • Self-Reported Quality of Life

    4 months

    FatigueBladder, bowel and sexual functionPainQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over · EDSS 0 to 7.0

Show the full criteria

Inclusion criteria

1. Men and women age 18 years or older 2. Diagnosis of multiple sclerosis per the 2014 Revised MacDonald criteria 3. Moderate to severe insomnia based on Insomnia Severity Index score 4. Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 7.0 5. Stable medications and disease activity for the past 30 days 6. Willingness to visit Griffin Hospital for up to 13 times if assigned to the mindfulness group, or up to 4 times if assigned to the sleep hygiene group, for study assessment and counseling or educational sessions

Exclusion criteria

1. Diagnosis of obstructive sleep apnea or narcolepsy 2. High risk of obstructive sleep apnea, as determined by the STOP-Bang questionnaire, if no known diagnosis of sleep apnea 3. Significant pulmonary, cardiac, hepatic or other medical conditions 4. Relapse of MS symptoms within the 30 days prior to study entry 5. Use of corticosteroids, either IV or oral, for exacerbations of symptoms 6. Inability to comply with the protocol 7. A lack of proficiency in reading, writing in, and understanding English 8. Body mass index (BMI) > 39 (350 lb. due to the limitations of the scale used for the study)

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

About this trial

In the sponsor's words

Purpose To determine whether Mindfulness-Based Treatment for Insomnia (MBTI) is more effective in the treatment of chronic insomnia disorder (CID) in patients with multiple sclerosis (MS) when compared with standard sleep hygiene counseling. Specific Aims / Hypotheses Our specific aims are to determine: * Whether MBTI is more effective than standard sleep hygiene counseling in improving objectively-measured sleep quality among this group of MS patients with CID, as measured by the Fitbit Charge 2 activity tracker. * Whether MBTI is more effective than standard sleep hygiene counseling in improving self-reported sleep quality among this group of MS patients with CID, as measured by the Pittsburgh Sleep Quality Index (PSQI). * Whether MTBI is more effective than standard sleep hygiene counseling in reducing self-reported severity of insomnia among this group of MS patients with CID, as measured by the Insomnia Severity Index (ISI). * Whether MBTI is more effective than standard sleep hygiene counseling in improving self-reported quality of life among this group of MS patients with CID, as measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI). We hypothesize that among study participants with MS and CID: * MBTI will improve their objectively-measured sleep quality, as measured by the Fitbit Charge 2 activity tracker. * MBTI will improve their self-reported sleep quality, as measured by the PSQI. * MBTI will reduce their self-reported severity of insomnia, as measured by the ISI. * Improvement in sleep quality and reduction in insomnia severity will result in improvement in self-reported quality of life, as measured by MSQLI scores. * MBTI will be superior to sleep hygiene counseling in improving sleep quality, reducing insomnia severity, and improving quality of life.

Papers

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History

    1. Started

      Dec 2017

    2. Main results due

      Dec 2019

    3. Finished

      Dec 2019

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