Evidence map›Paper›PMID 32169030›Full record

ArticleBMC pregnancy and childbirth2020

Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial.

Lianne P Hulsbosch, Ivan Nyklíček, Eva S Potharst, Margreet Meems, Myrthe G B M Boekhorst, Victor J M Pop

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pregnancy and childbirth, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 4% 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.

NCT03917745 nacompletednot on this map

E-health Intervention in Women With Pregnancy Distress: a Randomized Controlled Trial

TypeinterventionalSponsorTilburg UniversityRan2019 to 2022Enrolled219ConditionsPregnancy DistressArmseHealth mindfulness intervention
NCT05494840 nacompletednot on this mapstarted 2022, after this paper: background citation

The Effect of Prenatal Haptonomy on Pregnancy-related Anxiety, Distress and Psychological Well-being

TypeinterventionalSponsorHilal ÖzbekRan2022 to 2023Enrolled102ConditionsFirst PregnancyArmsHaptonomy
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.

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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

6 authors at 2 institutions in 1 country.

Lianne P HulsboschCenter of Research in Psychological and Somatic disorders (CoRPS), Department of Medical and Clinical Psychology, Tilburg University, P.O. BOX 90153, Warandelaan 2, 5000 LE, Tilburg, the Netherlands.
Ivan NyklíčekCenter of Research in Psychological and Somatic disorders (CoRPS), Department of Medical and Clinical Psychology, Tilburg University, P.O. BOX 90153, Warandelaan 2, 5000 LE, Tilburg, the Netherlands.
Eva S PotharstUvA minds, academic outpatient (child and adolescent) treatment center of the University of Amsterdam, Amsterdam, the Netherlands.
Margreet MeemsCenter of Research in Psychological and Somatic disorders (CoRPS), Department of Medical and Clinical Psychology, Tilburg University, P.O. BOX 90153, Warandelaan 2, 5000 LE, Tilburg, the Netherlands.
Myrthe G B M BoekhorstCenter of Research in Psychological and Somatic disorders (CoRPS), Department of Medical and Clinical Psychology, Tilburg University, P.O. BOX 90153, Warandelaan 2, 5000 LE, Tilburg, the Netherlands.
Victor J M PopCenter of Research in Psychological and Somatic disorders (CoRPS), Department of Medical and Clinical Psychology, Tilburg University, P.O. BOX 90153, Warandelaan 2, 5000 LE, Tilburg, the Netherlands. v.j.m.pop@tilburguniversity.edu.
Tilburg University · NLUniversity of Amsterdam · NL

Funding

ZonMw 543003202
6 · The paper itself

Abstract

backgroundPsychological distress during pregnancy is common: up to 20% of the childbearing women experience symptoms of depression and anxiety. Apart from the adverse effects on the woman herself, pregnancy distress can negatively affect pregnancy outcomes, infant health, postpartum mother-child interaction and child development. Therefore, the development of interventions that reduce pregnancy distress is very important. Mindfulness-based interventions (MBIs) show promising positive effects on pregnancy distress, but there is a need for randomized controlled trials with sufficient power. Trials on online MBIs, which are readily accessible and not expensive, also show positive effects on stress reduction in non-pregnant populations. Moreover, specific working mechanisms of MBIs remain unclear. The aim of the current study is to test the effectiveness of an online MBI in pregnant women with pregnancy distress, as well as exploring potential working mechanisms.

methodsThe current study is a randomized controlled trial with repeated measures. Consenting women with elevated levels of pregnancy distress will be randomized into an intervention group (MBI) or control group (care as usual) around 12 weeks of pregnancy, with an intended sample size of 103 women in each group. The primary outcome, pregnancy distress, will be assessed via questionnaires at baseline, halfway through the intervention and post intervention in both intervention and control group, and after 8 weeks follow-up in the intervention group. Secondary outcomes are mindfulness skills, rumination and self-compassion, which are also seen as potential working mechanisms, and will be assessed via questionnaires before intervention, halfway through the intervention, post intervention and after 8 weeks follow-up in the intervention group. Tertiary outcome variables are obstetric data and will be collected from the obstetric records for both intervention and control group. Analyses will be based on the intention-to-treat principle. Multilevel regression models for repeated measures (mixed models) will be used to evaluate changes in primary and secondary outcome variables. Tertiary outcomes will be compared between groups using independent t-tests and Chi Square analyses. DISCUSSION: The trial is expected to increase knowledge about the effectiveness of online MBIs during pregnancy in women with pregnancy distress and to evaluate potential working mechanisms.

trial registrationClinicalTrials.gov: NCT03917745, registered on 4 March 2019. Protocol Version 3.0., 20 February 2020.

Indexed as

AnxietyDepressionFemaleHumansMindfulnessNetherlandsPregnancyPregnancy ComplicationsRandomized Controlled Trials as TopicStress, PsychologicalSurveys and QuestionnairesTreatment OutcomeAnxietyDepressionMindfulnessOnline interventionPregnancy distress

Identifiers

PMID32169030
PMCPMC7069182
OpenAlexW3012174980

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.