Evidence map›Paper›PMID 32559716›Full record

Trial reportSleep medicine2020

A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women.

David A Kalmbach, Philip Cheng, Louise M O'Brien, Leslie M Swanson, Roopina Sangha, Srijan Sen, Constance Guille, Andrea Cuamatzi-Castelan, Alasdair L Henry, Thomas Roth and 1 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Sleep medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03596879 (Insomnia and Rumination in Late-pregnancy and the Risk for Postpartum Depression), which is not on this map. Cited by 76 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 14 pooled it
17.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03596879 nacompletednot on this map

Insomnia and Rumination in Late-pregnancy and the Risk for Postpartum Depression (PPD): A Randomized Controlled Trial of Online Cognitive Behavioral Therapy for Insomnia to Prevent PPD

TypeinterventionalSponsorHenry Ford Health SystemRan2018 to 2019Enrolled91ConditionsInsomnia, Post Partum DepressionArmsdCBTI, Sleep Education
3 · Its place in the literature

Who cites it

76 citing papers in PubMed, 14 syntheses or guidelines pooled it, 154 citations in OpenAlex.

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  5. Effectiveness of nonpharmacological sleep interventions in pregnancy: a systematic review and meta-analysis.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
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  19. Sleeping for Two: a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnancy.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
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16 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 2 countries.

David A KalmbachThomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA. Electronic address: dkalmba1@hfhs.org.
Philip ChengThomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.
Louise M O'BrienDepartments of Obstetrics & Gynecology and Neurology, University of Michigan, Ann Arbor, MI, USA.
Leslie M SwansonDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Roopina SanghaDepartment of Obstetrics & Gynecology, Henry Ford Health System, Detroit, MI, USA.
Srijan SenDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Constance GuilleDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
Andrea Cuamatzi-CastelanThomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.
Alasdair L HenryBig Health Inc, San Francisco, CA, USA; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
Thomas RothThomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.
Christopher L DrakeThomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.
Henry Ford Health System · USUniversity of Michigan · USMedical University of South Carolina · USUniversity of Oxford · GB

Funding

Enhancing digital CBT-I to improve adherence and reduce disparitiesR01HL159180 · NHLBI · HENRY FORD HEALTH SYSTEM · PI CHENG, PHILIP · 2021 to 2025
$3.0M
Physiologic Investigation of the Renin-Angiotensin-Aldosterone System to Understand Arterial Inflammation in HIVK23HL136262 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI SRINIVASA, SUMAN · 2017 to 2021
$960k
Sleep-Disordered Breathing and PAP in Perinatal DepressionK23HL122461 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SWANSON, LESLIE M · 2015 to 2019
$813k
Clinical translation of phenotypes of shift work disorderK23HL138166 · NHLBI · HENRY FORD HEALTH SYSTEM · PI CHENG, PHILIP · 2017 to 2021
$761k
NHLBI NIH HHS K23 HL122461NHLBI NIH HHS K23 HL136262NHLBI NIH HHS K23 HL138166NHLBI NIH HHS R01 HL159180
6 · The paper itself

Abstract

objectiveDespite 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.

methodsSingle-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.

resultsFrom 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.

conclusionsDigital 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.

Indexed as

Cognitive Behavioral TherapySleep Initiation and Maintenance DisordersFemaleHumansPregnancyPregnant PeopleSleepTreatment OutcomeCognitive arousalDepressionPerinatalPostpartumPregnancyRCT

Identifiers

PMID32559716
PMCPMC8210706
OpenAlexW3012822780

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.