Discussion
anxiety, breast cancer, nonMS, sleepiness, daytime fatigue, insomnia, SE, depression
BREAST CANCER, SECONDARY, DYSFUNCTION, CHRONIC INSOMNIA
This pilot study represents the first reported randomized controlled study of mindfulness training compared to an active comparator (SH) to treat chronic insomnia in persons with MS. Outcome measures utilized standard objective and subjective measures of sleep. Additional study design features included a 16 week follow up assessment to determine duration of effect, as well as an expanded eMBSI cohort that included the original MBSI-I cohort and ten individuals who completed the SH program and assessments and then crossed over to join the 10-week MBSI sessions and follow up evaluations. One prospective insomnia study of mindfulness in MS also used actigraphy and self-reported sleep measures to compare mindfulness delivered via videoconferencing vs. in person but used a nonrandomized study design by comparing mindfulness to a wait-list control group [SE in our study did not improve with MBSI-I compared with SH and, therefore, the primary hypothesis was not met. SE also did not improve within the MBSI-I groups nor the SH group. It should be noted that SE was higher than would have been expected for cohorts of persons with insomnia, approaching 90%, suggesting a ceiling effect. By contrast, SE in the Lorenz study was 56.7%. SE reported in other studies ranged from the low 70 s to mid-80 s, with SEs measured by actigraphy tending to be higher than those obtained from sleep diaries [However, one component of SE did change significantly in the mindfulness groups in our study. We found that sleep time decreased significantly in the mindfulness groups, particularly in the post intervention period. Sleep time is a major component of both the numerator and denominator of SE, so overall sleep efficiency remained unchanged. Also of note, evening sleep time in our study averaged 6.8 h, well above that reported in the Lorenz study (5.2 h). This counterintuitive result in our study was also observed in a randomized study comparing a six-week mindfulness program to usual care in 79 breast cancer survivors with chronic insomnia [Our subjective secondary sleep measures confirmed that our study cohort had a moderate level of insomnia both on the PSQI and ISI, which suggest that our participants may have perceived less restful sleep because of overlapping problems with daytime fatigue. Both average scores for the PSQI and ISI, between 9 and 10 and 16 to 17, respectively, indicate moderate insomnia [Results of secondary sleep measures in the study showed significant benefits for the mindfulness cohorts, including the ISI and the component scores of the PSQL, e.g., sleep latency, day dysfunction due to sleepiness and overall sleep quality. Although these outcomes showed stronger within group effects than between mindfulness and SH cohorts.This is consistent with observations found in similar studies of mindfulness treatment in nonMS populations [One interesting observation is that the ISI improved significantly in the SH cohort at the 16-week but not the 10-week assessment. This appears to be a relatively isolated assessment as none of the other sleep parameters showed improvement in the SH group. However, this does not rule out the continued benefits and possible practice effects of sleep hygiene principles, which makes the possibility of carryover benefits of SH participants in the eMBSI-I cohort relevant (discussed below).While our data showed continued positive benefits to mindfulness on subjective sleep parameters extended to six weeks post intervention, one challenge is that the positive effects of mindfulness may not be long lived, or superior to SH over the longer term. A study of an online mindful meditation program in MS showed benefits in terms of quality of life, anxiety, depression and sleep post intervention but these effects were no longer significant at six months [In order to increase the power of the study, given the low numbers of participants, the MBSI-I was expanded to include participants who were originally part of the SH cohort and this eMBSI-I cohort generally showed more robust benefit in some sleep parameters than the smaller MBSI-I cohort. This could reflect greater statistical power to detect differences or carryover effects from the combined treatments. To adequately assess carryover effects in the study design, we would have had to control for this using a parallel extended design for both groups, which would have been impractical.Other outcomes indicated significant benefits for MBSI-I relative to SH in self-report quality of life measures, similar to what has been reported in other studies [