Clinical trial NCT00515177: Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study
Official title: Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Insomnia
Primary Insomnia
Keywords: mindfulness
meditation
MBSR
mindfulness meditation
sleep
insomnia
chronic insomnia
primary insomnia
Minnesota
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Hennepin County Medical Center, Minneapolis
First posted: 2007-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 weeks and 5 months
measure: Insomnia Severity Index
timeFrame: 8 weeks and 5 months
measure: Actigraphy
timeFrame: 8 weeks
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 8 weeks and 5 months
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 8 weeks and 5 months
measure: Medical Outcome Study Short Form (SF-12)
timeFrame: 8 weeks and 5 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minnesota Regional Sleep Disorders Center at Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Cynthia R Gross, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Mary Jo Kreitzer, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gross CR, Kreitzer MJ, Reilly-Spong M, Wall M, Winbush NY, Patterson R, Mahowald M, Cramer-Bornemann M. Mindfulness-based stress reduction versus pharmacotherapy for chronic primary insomnia: a randomized controlled clinical trial. Explore (NY). 2011 Mar-Apr;7(2):76-87. doi: 10.1016/j.explore.2010.12.003.