| Title: | A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis |
|---|
| Status: | Completed |
|---|
| Topic: | Complementary & Alternative Medicine;Multiple Sclerosis |
|---|
| Funding Source: | State of Connecticut: Biomedical Research Trust Fund |
|---|
| Funding Period: | 2016-2020 |
|---|
| Study Design: | Randomized controlled trial |
|---|
| Purpose: | The purpose of this study was to examine whether mindfulness meditation would be more effective than standard sleep hygiene counseling in treating insomnia and improving quality of life in MS patients. Many MS patients suffer from chronic insomnia, leading to daytime impairment. Pharmacological treatments for MS may also contribute to insomnia, and may have adverse side effects. A potential alternative treatment involves mindfulness – focusing one’s attention on the present moment without judgment. Mindfulness is hypothesized to increase the 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. |
|---|
| Further Study Details: | Each participant was randomly assigned to one of two groups. One group attended 10 weekly sessions of mindfulness-based training for insomnia. The other group attended a single group session on sleep hygiene. During the study, members of both groups wore Fitbit devices each day for several weeks to record their sleep data. At two study time points, they completed a set of questionnaires and visited the PRC for clinical assessments.Study outcome measures included sleep efficency using 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, and self-reported quality of life (MS Quality of Life Inventory, a set of questionnaires to measure self-reported overall health status, fatigue, pain, sexual satisfaction, bladder control, bowel control, visual impairment, cognitive dysfunction, mental health, and social support). Participants were also monitored for any progression of MS symptoms, muscle spasticity, restless legs syndrome, and any adverse events. |
|---|
| Findings: | Mindfulness training led to significant improvements in self-reported sleep quality, insomnia severity, fatigue, cognitive function and mental health, which were all secondary outcome measures. It did not lead to a significant improvement in sleep efficiency, which was the primary outcome measure. |
|---|
| Eligibility: | Men and women age 18 years or older diagnosed with MS, and with a history of chronic insomnia, but no known history of obstructive sleep apnea or narcolepsy. |
|---|
| Evaluation: | Study outcome measures included 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 were also monitored for any progression of MS symptoms, muscle spasticity, restless legs syndrome, and any adverse events. |
|---|
Yale-Griffin Prevention Research Center