JMIR Publications

ABSTRACT

Background:

Prenatal Insomnia symptoms are prevalent, debilitating and largely untreated, however, there is a lack of empirically supported and accessible interventions. Mindfulness-based interventions have been theoretically hypothesized to alleviating insomnia symptoms by counteracting the adverse sleep-related cognitive and behavioral processes, although few studies have tested them.

Objective:

This study aimed to examine the effectiveness and potential mechanisms of a digital mindfulness-based intervention targeted at prenatal insomnia (dMBI-PI) on reducing insomnia symptoms.

Methods:

A single-blind randomized controlled trial was conducted from October 2021 to February 2023. A total of 160 eligible pregnant women (mean (SD) age, 30.54 (3.86) years) with sub-threshold to clinical insomnia symptoms were 1:1 randomized into the intervention group (the 6-week dMBI-PI plus standardized care) or the control group (standardized care). The primary outcome was the insomnia symptoms assessed at baseline, post-intervention, two months after post-intervention (the third trimester) and 42 days postpartum. The secondary outcomes included insomnia remission rates and reliable change rates, sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency, sleep quality, fatigue symptoms, daytime sleepiness, anxiety and depressive symptoms. The hypothesized mediators included sleep-specific rumination, sleep-specific worry, pre-sleep arousal, sleep-related attentional bias and maladaptive behaviors. Linear-mixed model analysis was conducted to examine the dMBI-PI’s effects.

Results:

Compared with the control group, the intervention group had significantly greater improvements in insomnia symptoms from baseline to post-intervention (mean [95% CI] between-group difference, -2.02 [-3.42 to -0.62], P = 0.005; Cohen d [95% CI], 0.46 [0.01 to 0.92]) and from baseline to the third trimester (mean [95% CI] between-group difference, -2.02 [-3.42 to -0.61], P = 0.005; Cohen d [95% CI], 0.46 [0.01 to 0.92]), but such beneficial effect was not observed at postpartum. The intervention group had a significantly increased likelihood of achieving insomnia remission or reliable change at the third trimester; however, we did not observe significant between-group differences in the changes of most secondary outcomes. The changes of adverse cognitive and behavioral processes (mainly sleep-specific worry and pre-sleep arousal) could significantly mediate the dMBI-PI’s effect on prenatal insomnia symptoms.

Conclusions:

Digital MBIs showed significant short-term benefits on prenatal insomnia symptoms by mitigating sleep-specific worry and pre-sleep arousal and thus may hold promise as a low-intensity, pragmatic and accessible option for pregnant women at risk of insomnia. Clinical Trial: Chinese Clinical Trial Register ChiCTR2100052269; https://www.chictr.org.cn/showproj.html?proj=134780