A Phase 2/3 interventional study of Mindfulness-Based Stress Reduction and eszopiclone in Chronic Insomnia and Primary Insomnia, sponsored by University of Minnesota. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-03-29.
Sponsored by University of Minnesota · Phase 2/3, Interventional, and Treatment
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.
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.
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This study's enrollment of 30 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
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
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.
Drug: eszopiclone
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
Also known as: LUNESTA®
Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: 8 weeks and 5 months
Insomnia Severity Index
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.
Time frame: 8 weeks and 5 months
Actigraphy
Total Sleep Time from Actigraphy
Time frame: 8 weeks
State-Trait Anxiety Inventory (STAI)
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.
Time frame: 8 weeks and 5 months
Center for Epidemiological Studies Depression Scale (CES-D)
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.
Time frame: 8 weeks and 5 months
Medical Outcome Study Short Form (SF-12)
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.
Time frame: 8 weeks and 5 months
Participants were recruited through newspaper, radio advertisements and Internet.
| Milestone | MBSR | Pharmacotherapy Control Arm |
|---|---|---|
| Started | 20 | 10 |
| Completed | 18 | 9 |
| Not completed | 2 | 1 |
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.
| units on a scale | MBSR | Pharmacotherapy Control Arm |
|---|---|---|
| 8 weeks | 7.7 ± 3.6 | 9.2 ± 2.0 |
| 5 months | 7.0 ± 4.6 | 8.2 ± 2.7 |
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.
| units on a scale | MBSR | Pharmacotherapy Control Arm |
|---|---|---|
| 8 week | 9.6 ± 4.2 | 9.1 ± 4.6 |
| 5 months | 8.1 ± 5.5 | 7.8 ± 4.3 |
Total Sleep Time from Actigraphy
| hours | MBSR | Pharmacotherapy Control Arm |
|---|---|---|
| Actigraphy | 6.2 ± 0.8 | 6.9 ± 0.6 |
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.
| units on a scale | MBSR | Pharmacotherapy Control Arm |
|---|---|---|
| 8 week | 32.9 ± 12.0 | 31.3 ± 14.9 |
| 5 months | 30.1 ± 11.8 | 28.3 ± 8.5 |
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.
| units on a scale | MBSR | Pharmacotherapy Control Arm |
|---|---|---|
| 8 week | 10.0 ± 8.5 | 10.1 ± 12.1 |
| 5 months | 8.4 ± 7.6 | 7.0 ± 5.8 |
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.
| units on a scale | MBSR | Pharmacotherapy Control Arm |
|---|---|---|
| 8 week | 48.8 ± 8.5 | 48.3 ± 12.7 |
| 5 months | 49.7 ± 10.1 | 50.1 ± 6.7 |
Collected over Adverse events were queried weekly from intervention start to 12 weeks, bi-monthly in month 4, monthly in months 5 (intervention end) and 6 (post-intervention).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pharmacotherapy (Eszopiclone, 3mg) | — | 0/10 (0%) | 7/10 (70%) |
| MBSR | — | 0/20 (0%) | 0/20 (0%) |
| Event | Pharmacotherapy (Eszopiclone, 3mg) | MBSR |
|---|---|---|
| Taste disturbanceGeneral disorders | 4/10 | 0/20 |
| Excessive sleepinessNervous system disorders | 3/10 | 0/20 |
| HeadacheGeneral disorders | 2/10 | 0/20 |
| DizzinessNervous system disorders | 2/10 | 0/20 |
| RefluxGastrointestinal disorders | 1/10 | 0/20 |
| AnxietyPsychiatric disorders | 1/10 | 0/20 |
| HypertensionRenal and urinary disorders | 1/10 | 0/20 |
| Strange dreamsNervous system disorders | 1/10 | 0/20 |
| Age, Categorical(Participants) | Randomized to MBSR | Randomized to PCT | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 10 | 29 |
| >=65 years | 1 | 0 | 1 |
| Age Continuous(years) | Randomized to MBSR | Randomized to PCT | Total |
|---|---|---|---|
| Median | 47 (21 to 65) | 53.5 (29 to 59) | 51 (21 to 65) |
| Sex: Female, Male(Participants) | Randomized to MBSR | Randomized to PCT | Total |
|---|---|---|---|
| Female | 15 | 7 | 22 |
| Male | 5 | 3 | 8 |
| Region of Enrollment(participants) | Randomized to MBSR | Randomized to PCT | Total |
|---|---|---|---|
| United States | 20 | 10 | 30 |
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
University of Minnesota