- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00515177
Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study (MVP#1)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Minneapolis, Minnesota, United States, 55415
- Minnesota Regional Sleep Disorders Center at Hennepin County Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronic insomnia defined as a) sleep onset latency and/or wake after sleep onset longer than 30 minutes per night, at least 3 nights per week; and b) Insomnia duration of at least 6 months, by self-report; and c) minimum of 1 daytime complaint by self-report (e.g. fatigue, mood disturbance);
- Between 18 and 65 years of age;
- English-speaking;
- Literate;
- Mentally intact;
- Interested in either medication or mind-body interventions;
- Able to attend weekly classes in a Minnesota Metro area;
- Able to comply with study sleep monitoring requirements;
- Willing to complete the informed consent process.
Exclusion Criteria:
- Sleep apnea or other primary sleep disorder suspected of being responsible for insomnia;
- Mental disorder or substance (including medications) suspected of being responsible for insomnia;
- General medical condition suspected of being responsible for the insomnia;
- Medically unstable (a hospital admission for non-elective purposes in the last 3 months or major surgery planned in the next 3 months);
- Serious preexisting mental health issues: suicidality or thought disorder/psychosis; or delirium or substance abuse;
- Treatment for depression or anxiety with initiation of therapy or dosage change within the last 6 months;
- Use of non-prescription sleep aids and unwilling or unable to discontinue these during the study;
- Use of prescription sleep medications or other medications known to affect sleep or be contraindicated with use of hypnotics, and unwilling or unable to discontinue these during the study;
- Known allergy to eszopiclone;
- Shift worker;
- Pregnant , breast-feeding or planning pregnancy in next 6 months;
- Previous cognitive behavioral therapy for insomnia or current psychotherapy;
- Prior MBSR class or regularly practicing mindfulness meditation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MBSR
A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.
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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.
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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.
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One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of "as needed" use
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 8 weeks and 5 months
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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.
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8 weeks and 5 months
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Insomnia Severity Index
Time Frame: 8 weeks and 5 months
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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.
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8 weeks and 5 months
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Actigraphy
Time Frame: 8 weeks
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Total Sleep Time from Actigraphy
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State-Trait Anxiety Inventory (STAI)
Time Frame: 8 weeks and 5 months
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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.
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8 weeks and 5 months
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Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: 8 weeks and 5 months
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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.
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8 weeks and 5 months
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Medical Outcome Study Short Form (SF-12)
Time Frame: 8 weeks and 5 months
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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.
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8 weeks and 5 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary Jo Kreitzer, RN, PhD, University of Minnesota
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0705M09301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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