Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study
Condition: Chronic Insomnia; Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Chronic insomnia is a major public health problem that affects about 10% of adults and is
      associated with serious and distressful health consequences such as depression, anxiety and
      reduced quality of life. Sleep medications are effective, but side effects, costs and
      uncertain long term efficacy call for non-pharmacologic alternatives. Mindfulness-Based
      Stress Reduction (MBSR), a standardized program of training in mindfulness meditation and
      yoga, is a promising new approach for treating chronic insomnia. MBSR was developed to
      facilitate adaptation to the stressors of medical illness. It is hypothesized that
      mindfulness training reduces arousal and unhelpful cognitions that promote and sustain
      chronic insomnia. The Mindfulness Versus Pharmacotherapy trial (MVP#1) is a pilot study
      designed to establish the feasibility and determine the optimal design for a full-scale trial
      comparing MBSR to prescribed sleep medication for treatment of chronic insomnia. For this
      pilot, we will randomize persons with primary chronic insomnia (actual sample of 30 persons)
      to 2 groups : 1) MBSR (8-weeks of group instruction followed by 3-months of home practice);
      and 2) PCT (3 mg of LUNESTA(eszopiclone) nightly for 8-weeks followed by 3-months of "as
      needed" use). Both groups will have telephone monitoring for side effects, adherence
      tracking, and objective sleep assessment by actigraphy. The primary outcomes are sleep
      quality, sleep quantity and insomnia severity assessed by well-validated self-report scales,
      objective sleep parameters measured by wrist actigraphy, depression and anxiety symptoms,
      health-related quality of life and workplace productivity. We hypothesize that those in the
      MBSR group will have improved sleep outcomes. Outcomes will be assessed at 8-weeks (the end
      of the active intervention phase) and 5 months follow-up. Outcomes will be compared to
      baseline values and measures reflecting proposed mechanisms of action to determine if
      clinically important impacts are likely to be obtainable in a full-scale trial. After
      follow-up data have been collected, participants will be invited to participate in focus
      groups to share their impressions of the study interventions to identify issues that could be
      addressed in a full-scale trial. Our long-range goal is to provide evidence-based
      recommendations for safe, practical and cost-effective non-pharmacologic treatment options
      for chronic insomnia.
    

Detailed description: 
      The NIH's 2003 National Sleep Disorders Research Plan defines insomnia as "difficulty falling
      asleep, difficulty staying asleep or short sleep duration, despite adequate opportunity for
      sleep," and estimates that it affects 30% to 40% of adults. The prevalence of chronic
      insomnia, defined as sleep disturbances for 4 weeks or more, sleep disruption with daytime
      impairment, or regular, nightly sleep difficulty, is about 10% of the general population,
      with higher rates among women, older adults and clinical populations. Total direct and
      indirect costs of insomnia are estimated to be roughly $113 billion annually. While only
      about 3 million of the 70 million Americans with insomnia take prescription medications,
      annual prescription drug costs for insomnia exceed $2.1 billion dollars.

      Mindfulness-Based Stress Reduction (MBSR), a standardized group program of training in
      mindfulness meditation and yoga, is a promising intervention for lifelong self-management of
      chronic insomnia. Mindfulness meditation training has been found to improve sleep outcomes in
      patients with chronic illnesses. Meditation may be defined as self-regulation of attention,
      and mindfulness has been described as paying attention in a particular, intentional way,
      moment-by-moment, without judging. MBSR originated with the Stress Reduction Clinic at the
      University of Massachusetts Medical Center and is currently used in over 250 clinics,
      hospitals, and health maintenance organizations in the US and abroad
      (www.umassmed.edu/cfm/srp/).

      MVP#1 is a pilot study to establish feasibility, refine procedures and determine the optimal
      design for a planned full-scale trial. An active control drug, eszopiclone which is a widely
      used and FDA approved prescription sleep medication, is included in the pilot to provide a
      benchmark for efficacy. Outcomes will evaluated to determine if clinically important impacts
      are likely to be obtainable in the future full-scale trial.
    

Intervention name(s): Mindfulness-Based Stress Reduction; eszopiclone
Intervention type(s): Behavioral; Drug
Intervention description(s): The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness.; One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of "as needed" use
Other intervention name(s): LUNESTA®
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: mindfulness; meditation; MBSR; mindfulness meditation; sleep; insomnia; chronic insomnia; primary insomnia; Minnesota