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Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial.
BMC Pregnancy Childbirth. 2020 Mar 13; 20(1):159.BP

Abstract

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.

Authors+Show Affiliations

Center 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.Center 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.UvA minds, academic outpatient (child and adolescent) treatment center of the University of Amsterdam, Amsterdam, the Netherlands. Research Institute of Child Development and Education, University of Amsterdam, Nieuwe Achtergracht 127, Amsterdam, the Netherlands.Center 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.Center 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.Center 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.

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

32169030

Citation

Hulsbosch, Lianne P., et al. "Online Mindfulness-based Intervention for Women With Pregnancy Distress: Design of a Randomized Controlled Trial." BMC Pregnancy and Childbirth, vol. 20, no. 1, 2020, p. 159.
Hulsbosch LP, Nyklíček I, Potharst ES, et al. Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial. BMC Pregnancy Childbirth. 2020;20(1):159.
Hulsbosch, L. P., Nyklíček, I., Potharst, E. S., Meems, M., Boekhorst, M. G. B. M., & Pop, V. J. M. (2020). Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial. BMC Pregnancy and Childbirth, 20(1), 159. https://doi.org/10.1186/s12884-020-2843-0
Hulsbosch LP, et al. Online Mindfulness-based Intervention for Women With Pregnancy Distress: Design of a Randomized Controlled Trial. BMC Pregnancy Childbirth. 2020 Mar 13;20(1):159. PubMed PMID: 32169030.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial. AU - Hulsbosch,Lianne P, AU - Nyklíček,Ivan, AU - Potharst,Eva S, AU - Meems,Margreet, AU - Boekhorst,Myrthe G B M, AU - Pop,Victor J M, Y1 - 2020/03/13/ PY - 2019/11/02/received PY - 2020/02/25/accepted PY - 2020/3/15/entrez PY - 2020/3/15/pubmed PY - 2020/3/15/medline KW - Anxiety KW - Depression KW - Mindfulness KW - Online intervention KW - Pregnancy distress SP - 159 EP - 159 JF - BMC pregnancy and childbirth JO - BMC Pregnancy Childbirth VL - 20 IS - 1 N2 - 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. SN - 1471-2393 UR - https://www.unboundmedicine.com/medline/citation/32169030/Online_mindfulness_based_intervention_for_women_with_pregnancy_distress:_design_of_a_randomized_controlled_trial_ L2 - https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-020-2843-0 DB - PRIME DP - Unbound Medicine ER -