Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Minnesota University of Minnesota - Clinical and Translational Science Institute