Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study (MVP#1)
Behavioral: Mindfulness-Based Stress Reduction
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study|
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 weeks and 5 months ] [ Designated as safety issue: No ]The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.
- Insomnia Severity Index [ Time Frame: 8 weeks and 5 months ] [ Designated as safety issue: No ]The Insomnia Severity Index is a 7-item scale that provides a total score indicating current (e.g., last 2 weeks) severity of insomnia symptoms with scores that can range from 0 to 28. Scores of 15 or higher indicate clinical insomnia.
- Actigraphy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Total Sleep Time from Actigraphy
- State-Trait Anxiety Inventory (STAI) [ Time Frame: 8 weeks and 5 months ] [ Designated as safety issue: No ]The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.
- Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: 8 weeks and 5 months ] [ Designated as safety issue: No ]The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.
- Medical Outcome Study Short Form (SF-12) [ Time Frame: 8 weeks and 5 months ] [ Designated as safety issue: No ]Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.
|Study Start Date:||August 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
Behavioral: Mindfulness-Based Stress Reduction
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.
Active Comparator: PCT Sleeping Pills
A pharmacotherapy control arm (PCT Sleeping Pills) consisting of a state-of-the-art prescription sedative hypnotic, eszopiclone - brand name LUNESTA(R), at a dose of one 3 milligram (mg) pill nightly for a duration of 8 weeks followed by use as needed (same dosage) for 3 months. This drug was approved by the Food and Drug Administration as a sedative for more than short term use.
One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of "as needed" use
Other Name: LUNESTA®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515177
|United States, Minnesota|
|Minnesota Regional Sleep Disorders Center at Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Cynthia R Gross, PhD||University of Minnesota - Clinical and Translational Science Institute|
|Principal Investigator:||Mary Jo Kreitzer, RN, PhD||University of Minnesota - Clinical and Translational Science Institute|