Cargando…

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

BACKGROUND: Psychological 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 i...

Descripción completa

Detalles Bibliográficos
Autores principales: Hulsbosch, Lianne P., Nyklíček, Ivan, Potharst, Eva S., Meems, Margreet, Boekhorst, Myrthe G. B. M., Pop, Victor J. M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7069182/
https://www.ncbi.nlm.nih.gov/pubmed/32169030
http://dx.doi.org/10.1186/s12884-020-2843-0
_version_ 1783505730790227968
author Hulsbosch, Lianne P.
Nyklíček, Ivan
Potharst, Eva S.
Meems, Margreet
Boekhorst, Myrthe G. B. M.
Pop, Victor J. M.
author_facet Hulsbosch, Lianne P.
Nyklíček, Ivan
Potharst, Eva S.
Meems, Margreet
Boekhorst, Myrthe G. B. M.
Pop, Victor J. M.
author_sort Hulsbosch, Lianne P.
collection PubMed
description BACKGROUND: Psychological 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. METHODS: The 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 REGISTRATION: ClinicalTrials.gov: NCT03917745, registered on 4 March 2019. Protocol Version 3.0., 20 February 2020.
format Online
Article
Text
id pubmed-7069182
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-70691822020-03-18 Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial Hulsbosch, Lianne P. Nyklíček, Ivan Potharst, Eva S. Meems, Margreet Boekhorst, Myrthe G. B. M. Pop, Victor J. M. BMC Pregnancy Childbirth Study Protocol BACKGROUND: Psychological 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. METHODS: The 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 REGISTRATION: ClinicalTrials.gov: NCT03917745, registered on 4 March 2019. Protocol Version 3.0., 20 February 2020. BioMed Central 2020-03-13 /pmc/articles/PMC7069182/ /pubmed/32169030 http://dx.doi.org/10.1186/s12884-020-2843-0 Text en © The Author(s). 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Hulsbosch, Lianne P.
Nyklíček, Ivan
Potharst, Eva S.
Meems, Margreet
Boekhorst, Myrthe G. B. M.
Pop, Victor J. M.
Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial
title Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial
title_full Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial
title_fullStr Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial
title_full_unstemmed Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial
title_short Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial
title_sort online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7069182/
https://www.ncbi.nlm.nih.gov/pubmed/32169030
http://dx.doi.org/10.1186/s12884-020-2843-0
work_keys_str_mv AT hulsboschliannep onlinemindfulnessbasedinterventionforwomenwithpregnancydistressdesignofarandomizedcontrolledtrial
AT nyklicekivan onlinemindfulnessbasedinterventionforwomenwithpregnancydistressdesignofarandomizedcontrolledtrial
AT potharstevas onlinemindfulnessbasedinterventionforwomenwithpregnancydistressdesignofarandomizedcontrolledtrial
AT meemsmargreet onlinemindfulnessbasedinterventionforwomenwithpregnancydistressdesignofarandomizedcontrolledtrial
AT boekhorstmyrthegbm onlinemindfulnessbasedinterventionforwomenwithpregnancydistressdesignofarandomizedcontrolledtrial
AT popvictorjm onlinemindfulnessbasedinterventionforwomenwithpregnancydistressdesignofarandomizedcontrolledtrial