Evidence map›Paper›PMID 37343335›Full record

ArticleSleep medicine2023

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS): A single-arm proof-of-concept clinical trial of a mindfulness-based intervention for DSM-5 insomnia disorder during pregnancy.

David A Kalmbach, Philip Cheng, Anthony N Reffi, Jason C Ong, Leslie M Swanson, David M Fresco, Olivia Walch, Grace M Seymour, Cynthia Fellman-Couture, Alec D Bayoneto and 2 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Sleep medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04443959 (Telemedicine Mindfulness-based Therapy for Perinatal Insomnia), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT04443959 nacompletednot on this map

Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.

TypeinterventionalSponsorHenry Ford Health SystemRan2022 to 2022Enrolled12ConditionsInsomniaArmsPUMAS
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Article
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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

12 authors at 4 institutions in 1 country.

David A KalmbachThomas Roth Sleep Disorders & Research Center, Henry Ford Health, Detroit, MI, USA; Department of Obstetrics, Gynecology, and Reproductive Biology, Michigan State University College of Human Medicine, East Lansing, MI, USA. Electronic address: dkalmba1@hfhs.org.
Philip ChengThomas Roth Sleep Disorders & Research Center, Henry Ford Health, Detroit, MI, USA.
Anthony N ReffiThomas Roth Sleep Disorders & Research Center, Henry Ford Health, Detroit, MI, USA.
Jason C OngBehavioral Sleep Medicine, Nox Health, Suwanee, GA, USA; Center for Circadian and Sleep Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Leslie M SwansonDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
David M FrescoDepartment of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
Olivia WalchDepartment of Neurology, University of Michigan, Ann Arbor, MI, USA; Arcascope Inc, Chantilly, VA, USA.
Grace M SeymourThomas Roth Sleep Disorders & Research Center, Henry Ford Health, Detroit, MI, USA.
Cynthia Fellman-CoutureThomas Roth Sleep Disorders & Research Center, Henry Ford Health, Detroit, MI, USA.
Alec D BayonetoThomas Roth Sleep Disorders & Research Center, Henry Ford Health, Detroit, MI, USA.
Thomas RothThomas Roth Sleep Disorders & Research Center, Henry Ford Health, Detroit, MI, USA.
Christopher L DrakeThomas Roth Sleep Disorders & Research Center, Henry Ford Health, Detroit, MI, USA.
Henry Ford Health System · USUniversity of Michigan–Ann Arbor · USMichigan State University · USSleepMed · US

Funding

A Wearable Morning Light Treatment for Postpartum Depression: Confirming Efficacy and MechanismsR01MH121531 · NIMH · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SWANSON, LESLIE M · 2021 to 2024
$2.3M
Clinical translation of phenotypes of shift work disorderK23HL138166 · NHLBI · HENRY FORD HEALTH SYSTEM · PI CHENG, PHILIP · 2017 to 2021
$761k
NHLBI NIH HHS K23 HL138166NIMH NIH HHS R01 MH121531
6 · The paper itself

Abstract

objectivesCognitive-behavioral therapy is effective for prenatal insomnia, but unresolved cognitive arousal limits patient outcomes. Therapies aimed at reducing cognitive arousal may benefit pregnant women with insomnia. This proof-of-concept trial evaluated Perinatal Understanding of Mindful Awareness for Sleep (PUMAS, which combines mindfulness with behavioral sleep strategies) on insomnia, depression, and cognitive arousal.

methodsA single-arm trial of 12 pregnant women with DSM-5 insomnia disorder (n = 5/12 with comorbid depression) who received six sessions of PUMAS delivered individually via telemedicine. Pretreatment and posttreatment outcomes included the insomnia severity index (ISI), Edinburgh postnatal depression scale (EPDS), pre-sleep arousal scale's cognitive factor (PSASC; nocturnal cognitive arousal), perinatal-focused rumination (appended to PSASC), and Glasgow sleep effort scale.

resultsEleven of 12 patients completed all sessions. Intent-to-treat analyses revealed a 10.83-point reduction in ISI (Cohen's dz = 3.05), resulting in 83.3% insomnia remission. PUMAS produced large reductions in EPDS (Cohen's dz = 2.76 in depressed group), resulting in all five baseline depressed patients remitting from depression. PUMAS produced large reductions in nocturnal cognitive arousal, perinatal-focused rumination, and sleep effort (all Cohen's dzs>2.00). Patients were highly satisfied with PUMAS and identified the telemedicine format and meditation app as positive features of its delivery. Patients rated sleep restriction and guided meditations as the most helpful treatment components.

conclusionPrenatal insomnia patients were highly engaged in PUMAS, which produced large acute reductions in insomnia, depression, and cognitive arousal. These findings support the concept and feasibility of PUMAS for pregnant women with insomnia who present with or without comorbid depression. CLINICALTRIALS: GOV ID: NCT04443959.

Indexed as

MindfulnessPumaSleep Initiation and Maintenance DisordersAnimalsFemaleHumansPregnancyPregnant PeopleProof of Concept StudySleepTreatment OutcomeCognitive arousalDepressionMeditationMindfulnessPregnancyPUMASRuminationWorry

Identifiers

PMID37343335
PMCPMC10402889
OpenAlexW4380202680

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.