Currently submitted to: Journal of Medical Internet Research
Date Submitted: Jun 26, 2026
Open Peer Review Period: Jun 29, 2026 - Aug 24, 2026
(closed for review but you can still tweet)
NOTE: This is an unreviewed Preprint
Warning: This is a unreviewed preprint (What is a preprint?). Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn (a note "no longer under consideration" will appear above).
Peer review me: Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period (in this case, a "Peer Review Me" button to sign up as reviewer is displayed above). All preprints currently open for review are listed here. Outside of the formal open peer-review period we encourage you to tweet about the preprint.
Citation: Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author).
Final version: If our system detects a final peer-reviewed "version of record" (VoR) published in any journal, a link to that VoR will appear below. Readers are then encourage to cite the VoR instead of this preprint.
Settings: If you are the author, you can login and change the preprint display settings, but the preprint URL/DOI is supposed to be stable and citable, so it should not be removed once posted.
Submit: To post your own preprint, simply submit to any JMIR journal, and choose the appropriate settings to expose your submitted version as preprint.
Warning: This is an author submission that is not peer-reviewed or edited.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
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.