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A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women
Open accessAbstract
Objective Despite high rates of prenatal insomnia, efficacious treatment options for this population are quite limited. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy internet-based digital CBTI in pregnant women with insomnia.Methods Single-site RCT. A total of 91 pregnant women (29.03 ± 4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C) served as study outcomes, which were collected before treatment and after treatment during pregnancy, then six weeks after childbirth.Results From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008). Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 min per night (p = 0.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed.Conclusions Digital CBTI improves sleep quality and sleep duration during pregnancy and after childbirth. To better optimize outcomes, CBTI should be tailored to meet the changing needs of women as the progress through pregnancy and early parenting. NAME: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression. URL: clinicaltrials.gov. Registration: NCT03596879.
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“the remaining 14 studies in this review did not mention this issue [35, 36, 40, 44, 47, 50, 56, 66, 67, 69, 73–76].”
From Mental health-related telemedicine interventions for pregnant women and new mothers: a systematic literature review (2023) · cites this paper as [50]
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Digital Therapies for Insomnia
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Metadata
- Authors
- Kalmbach, D. A., Cheng, P., O'Brien, L. M., Swanson, L. M., Sangha, R., Sen, S., Guille, C., Cuamatzi-Castelan, A., Henry, A. L., Roth, T., & Drake, C. L.
- Affiliations
- Henry Ford Health (US)
- University of Michigan (US)
- Medical University of South Carolina (US)
- University of Oxford (GB)
- Corresponding author
- Kalmbach, David A.
- ORCID
- Venue
- Sleep Medicine
- Publisher
- Elsevier BV
- Published
- 2020-08
- Volume
- 72
- Pages
- 82-92
- ISSN
- 1389-9457 (ISSN-L)
- PMC
- PMC8210706
- OpenAlex
- W3012822780
- Cited by
- 154
- References
- 99
- Citations by year
- 2026: 16 · 2025: 27 · 2024: 23 · 2023: 38 · 2022: 27 · 2021: 20 · 2020: 3
- FWCI
- 21.28
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Sleep Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Heart, Lung, and Blood Institute
- American Academy of Sleep Medicine
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Maternal Mental Health During Pregnancy and Postpartum
- Keywords
- cognitive behavioral therapy for insomnia, online intervention, pregnant women, sleep quality, sleep duration, postpartum sleep, postpartum depression, sleep maintenance, cognitive arousal, rumination, sleep education
- MeSH terms
- Female, Humans, Sleep Initiation and Maintenance Disorders, Pregnancy, Sleep, Cognitive Behavioral Therapy, Treatment Outcome, Pregnant People, Pregnant Women
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