Mindfulness-based stress reduction versus pharmacotherapy for chronic primary insomnia: a randomized controlled clinical trial

Abstract

Objective: The aim of this study was to investigate the potential of mindfulness-based stress reduction (MBSR) as a treatment for chronic primary insomnia.

Design: A randomized controlled trial was conducted.

Setting: The study was conducted at a university health center.

Patients: Thirty adults with primary chronic insomnia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders, Text Revision, 4th Edition were randomized 2:1 to MBSR or pharmacotherapy (PCT).

Interventions: Mindfulness-based stress reduction, a program of mindfulness meditation training consisting of eight weekly 2.5 hour classes and a daylong retreat, was provided, with ongoing home meditation practice expectations during three-month follow-up; PCT, consisting of three milligrams of eszopiclone (LUNESTA) nightly for eight weeks, followed by three months of use as needed. A 10-minute sleep hygiene presentation was included in both interventions.

Main outcomes: The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diaries, and wrist actigraphy were collected pretreatment, posttreatment (eight weeks), and at five months (self-reports only).

Results: Between baseline and eight weeks, sleep onset latency (SOL) measured by actigraphy decreased 8.9 minutes in the MBSR arm (P < .05). Large, significant improvements were found on the ISI, PSQI, and diary-measured total sleep time, SOL, and sleep efficiency (P < .01, all) from baseline to five-month follow-up in the MBSR arm. Changes of comparable magnitude were found in the PCT arm. Twenty-seven of 30 patients completed their assigned treatment. This study provides initial evidence for the efficacy of MBSR as a viable treatment for chronic insomnia as measured by sleep diary, actigraphy, well-validated sleep scales, and measures of remission and clinical recovery.

Trial registration: ClinicalTrials.gov NCT00515177.

Copyright © 2011 Elsevier Inc. All rights reserved.

Figures

FIGURE 1. Participant Flow Diagram

The flow of participants through the study, from enrollment to follow-up is detailed by treatment group. Patients included in the outcome analyses are those who completed Mindfulness-based Stress Reduction (MBSR) or were treated with PCT (eszopiclone).

FIGURE 2

Scores on the Insomnia Severity Index are shown by patient and treatment arm, at baseline, 8-weeks and 5-months. Each line represents one patient. Patients in the MBSR arm are represented by solid dots, and patients in the PCT (eszopiclone) arm are represented by open dots. Criteria for severe, moderate, mild and no insomnia on the Insomnia Severity Index are marked by horizontal lines. The shaded area includes scores of 7 or lower, and corresponds to no insomnia on the Insomnia Severity Index.

FIGURE 3

Scores on the Pittsburgh Sleep Quality Index are shown by patient and treatment arm, at baseline, 8-weeks and 5-months. Each line represents one patient. Patients in the MBSR arm are represented by solid dots, and patients in the PCT (eszopiclone) arm are represented by open dots. Scores of 5 or lower on the Pittsburgh Sleep Quality Index are in the shaded area. Scores that fall above the shaded area meet the criterion for poor sleep on the Pittsburgh Sleep Quality Index.