Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis

Completed · Not applicable · Has a placebo group

Conditions studied: Insomnia Chronic, Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT03949296

Run by

Griffin Hospital

People needed

49

Starts

2017-12-11

Expected to finish

2019-12-16

Last updated by the study team

2020-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women age 18 years or older
• Diagnosis of multiple sclerosis per the 2014 Revised MacDonald criteria
• Moderate to severe insomnia based on Insomnia Severity Index score
• Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 7.0
• Stable medications and disease activity for the past 30 days
• 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

You may not qualify if…

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

Where it is running

• Yale-Griffin Prevention Research Center — Derby, Connecticut, United States

Full record on ClinicalTrials.gov

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