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Title: A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis
Status: Current
Topic: Complementary & Alternative Medicine;Multiple Sclerosis
Funding Source: State of Connecticut: Biomedical Research Trust Fund
Funding Period: 2016-2018
Study Design: Randomized controlled trial
Purpose:

This study will examine whether Mindfulness Meditation Treatment for Insomnia (MMTI) is more effective than standard sleep hygiene counseling in treating insomnia and improving quality of life in MS patients. About 25% to 40% of MS patients suffer from chronic insomnia, leading to daytime impairment. Treatments for MS and its related symptoms may also contribute to insomnia. Benzodiazepines and other medications to manage insomnia may have adverse effects such as dependence/tolerance, cognitive dysfunction, and depression. Therefore, it is desirable to find effective nonpharmacological treatments for insomnia in MS patients. One potential treatment involves mindfulness - focusing one’s full attention on the present moment without judgment - which is hypothesized to increase the awareness of, and ability to tolerate, thoughts and emotions, which in turn can reduce perceptions of stress, anxiety, and pain. Prior research has shown some benefits of mindfulness in treating insomnia in general, and some benefits of stress reduction techniques in managing MS-related insomnia. To date, however, there have been no studies on the efficacy of mindfulness techniques in treating MS-related insomnia.

Further Study Details:

Each of the 90 adults who enrolls in this study will be randomly assigned to one of two groups. One group will take part in 10 weekly sessions of mindfulness-based training for insomnia. The other group will attend a counseling session on sleep hygiene, and will be invited to attend a 2-hour session on mindfulness once their role in the study is complete. During the study, members of both groups will wear Fitbits each day for several weeks to record their sleep data. At two study time points, they will complete a set of questionnaires and will also visit Griffin for clinical assessments. Participants will be compensated a total of $200 over the duration of this study. All study visits and interventions, including MBTI sessions, will be free of charge.

Eligibility:

Men and women age 18 years or older who have been diagnosed with MS, and who have a history of chronic insomnia, but who do not have obstructive sleep apnea or narcolepsy. They must be willing to visit Griffin Hospital once for clinical screening, and subsequent times for counseling or educational sessions and for study assessment purposes.

Evaluation: Study outcome measures include objective sleep quality (using data collected from Fitbit Charge 2 devices); self-reported sleep quality (Pittsburgh Sleep Quality Index); self-reported insomnia (Insomnia Severity Index); self-reported quality of life (MS Quality of Life Inventory). Participants will also be monitored for any progression of MS symptoms, muscle spasticity, restless legs syndrome, and any adverse events.

Changed at: 11/30/2017 5:24 AM Changed by: Lisa Seaberg
Created at: 11/30/2017 5:24 AM Created by: Lisa Seaberg