Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis

Summary

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.

Conditions

• Insomnia Chronic
• Multiple Sclerosis

Interventions

BEHAVIORAL

Mindfulness Intervention

10-session program 1. Introduction to mindfulness and its potential benefits 2. Introduction to mindful practices and yoga poses 3. Conditioned reactions to stress; integrating mindfulness into everyday life 4. Challenges and insights gained in practicing mindfulness 5. Using mindfulness to observe and reduce negative means of reacting to stress, and find more effective responses 6. Reacting vs. responding to stressors 7. Self-regulation and coping with stressors and communication challenges 8. Fostering continuity of moment-to-moment awareness while practicing different forms of mindfulness 9. Choosing and creating one's own blend of mindfulness practices 10. Maintaining momentum to practice mindfulness once the program ends

BEHAVIORAL

Sleep Hygiene

Session includes a handout with15 sleep hygiene tips: 1. Maintain a regular sleep pattern 2. Only try to sleep when feeling tired or sleepy 3. If unable to sleep, do something calm until feeling tired and returning to bed 4. Avoid caffeine \& nicotine for 4-6 hours before going to bed 5. Avoid alcohol for 4-6 hours before going to bed 6. Use the bed only for sleeping and sex 7. Avoid naps during the day 8. Develop rituals to get relaxed and ready to sleep 9. Try a hot bath prior to bedtime 10. Avoid checking the clock during the night 11. Use a sleep diary for a few weeks to track progress 12. Avoid strenuous exercise before bedtime 13. Avoid a heavy meal before bedtime 14. Create a sleep environment that is quiet, comfortable, and dark 15. Maintain a regular daytime routine

Sponsors & Collaborators

• Yale-Griffin Prevention Research Center

  collaborator OTHER

• Yale University- Stress Center

  collaborator UNKNOWN

• Griffin Hospital

  lead OTHER

Principal Investigators

• Joseph B Guarnaccia, MD · Griffin Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-11

Primary Completion

2019-12-16

Completion

2019-12-16

Countries

• United States

Study Locations