Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study

NCT00515177 | Completed Phase 2 Results

• 1 other identifier: 0705M09301
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Insomnia; Primary Insomnia

Keywords

mindfulness; meditation; MBSR; mindfulness meditation; sleep; insomnia; chronic insomnia; primary insomnia; Minnesota

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  8 weeks and 5 months

• Actigraphy

  Total Sleep Time from Actigraphy

  8 weeks

Secondary Outcomes (3)

• State-Trait Anxiety Inventory (STAI)

  8 weeks and 5 months

• Center for Epidemiological Studies Depression Scale (CES-D)

  8 weeks and 5 months

• Medical Outcome Study Short Form (SF-12)

  8 weeks and 5 months

Study Arms (2)

MBSR

EXPERIMENTAL

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

PCT Sleeping Pills

ACTIVE COMPARATOR

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

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

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.

MBSR

eszopiclone DRUG

One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of "as needed" use

Also known as: LUNESTA®

PCT Sleeping Pills

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• Hennepin County Medical Center, Minneapolis: collaborator

Study Sites (2)

Minnesota Regional Sleep Disorders Center at Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 21397868 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Mindfulness-Based Stress Reduction; Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Results Point of Contact

• Title: Cynthia Gross PhD
• Organization: University of Minnesota

gross002@umn.edu

612-624-8676

Study Officials

• Cynthia R Gross, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Mary Jo Kreitzer, RN, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2007
• First Posted: August 13, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 29, 2013
• Results First Posted: March 29, 2013

Record last verified: 2013-02

Locations

US (2)