A randomized controlled trial of mindfulness meditation for chronic insomnia

Abstract

Study objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia.

Design: Three-arm, single-site, randomized controlled trial.

Setting: Academic medical center.

Participants: Fifty-four adults with chronic insomnia.

Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition.

Measurements and results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P < 0.05), with the largest difference occurring at the 3-month follow-up. Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up.

Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia.

Trial registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781.

Keywords: behavior therapy; clinical trial; complementary and alternative medicine; insomnia; meditation; mindfulness; sleep.

Figure 1

CONSORT study flow diagram. Participants in the self-monitoring (SM) arm were allocated to 8 weeks of SM, assessed at post SM, and then received 8 weeks of behavior therapy (BT), followed by assessments at post treatment and then at 3-month and 6-month follow-ups. Data for BT are not included in this report. MBSR, mindfulness-based stress reduction; MBTI, mindfulness-based therapy for insomnia.

Figure 2

Patient-reported outcomes. (A) Total wake time (in minutes; with standard error of the mean) across study arms as reported on sleep diaries. Data presented are change scores from baseline to each assessment point. Raw data (mean, standard deviation, effect sizes) for each arm are reported in Table 2. (B) Pre-sleep arousal scale (PSAS) total scores (with standard error of the mean) across study arms. Data presented are change scores from baseline to each assessment point. Raw data (mean, standard deviation, effect sizes) for each arm are reported in Table 2. (C) Insomnia Severity Index (ISI) total scores (with standard error of the mean) across the MBSR and MBTI arms. Data presented are change scores from baseline to each assessment point. Raw data (mean, standard deviation, effect sizes) for each arm are reported in Table 2. MBSR, mindfulness-based stress reduction; MBTI, mindfulness-based therapy for insomnia; SM, self-monitoring.

Figure 3

Treatment remission and treatment response. (A) Treatment remission. Percentage of patients who met criteria for treatment remission defined as Insomnia Severity Index (ISI) total score < 8 at each assessment point. Treatment remission for self-monitoring (SM) at post was 6.3% (not pictured). (B) Treatment response. Percentage of patients who met criteria for a minimally important treatment response defined as ISI total score reduction from baseline > 7 points at each assessment point. Treatment response at post for SM was 0.0% (not pictured). MBSR, mindfulness-based stress reduction; MBTI, mindfulness-based therapy for insomnia.