Currently submitted to: Journal of Medical Internet Research
Date Submitted: Jun 26, 2026
Open Peer Review Period: Jun 29, 2026 - Aug 24, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Internet-Delivered Cognitive Behavioral Therapy for Insomnia and Gut Microbiota Changes in Pregnant Women: Pilot Randomized Controlled Trial
ABSTRACT
Background:
Insomnia is common among pregnant women and has been associated with adverse pregnancy outcomes. Digital cognitive behavioral therapy for insomnia (dCBT-I) demonstrated efficacy in reducing insomnia. However, its potential remains to be fully uncovered in the pregnant population.
Objective:
To evaluate the feasibility and preliminary efficacy of internet-delivered CBT-I in pregnant women with insomnia and explore its potential effects on the gut microbiome.
Methods:
In this pilot randomized controlled trial, pregnant women with insomnia were recruited and randomized (1:1) to receive either internet-delivered CBT-I or sleep hygiene education. Self-report data were collected via REDCap at baseline, throughout the 5-week intervention, and at 2- and 6-week follow-ups. Feasibility outcomes included recruitment, retention, adherence, electronic sleep diary completion, actigraphy compliance, and safety. Sleep was assessed using Insomnia Severity Index (ISI), electronic sleep diary, and actigraphy. Stool samples collected at baseline and post-intervention and 16S rRNA gene sequencing were conducted.
Results:
Thirty-four participants were randomized, and 29 provided fecal samples. The intervention achieved high levels of engagement, including a session attendance rate of 94.1%, electronic sleep diary completion rate of 90.8%, and wearable device compliance rate of 67.1%, with no intervention-related adverse events reported. Compared with the control group, participants in the intervention group showed greater reductions in ISI and improvements in subjective sleep efficiency (SE). LEfSe identified enrichment of Ruminococcus in the control group at post-intervention, while MaAsLin2 showed a negative association between Cloacibacillus and changes in objective SE.
Conclusions:
Internet-delivered CBT-I was feasible, acceptable, and showed preliminary efficacy in reducing insomnia severity and improving subjective SE during pregnancy. High engagement and favorable preliminary outcomes support future large-scale interventions. This study also provided preliminary evidence linking sleep improvement to gut microbiome alterations. Clinical Trial: Chinese Clinical Trial Registry (ChiCTR), ChiCTR2500111690, https://www.chictr.org.cn/showproj.html?proj=248166
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