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

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.

Experiences and predictors of psychological distress in pregnant women living with HIV

“…Such a promising benefit may be that a single intervention programme that incorporates the predictors together could potentially mitigate psychological distress and promote healthy functioning in the study population. Quantitative findings thus aligned with related studies that have demonstrated that these predictors are imperative for reducing psychological distress (Brion et al, 2014;Deko et al, 2016;Hulsbosch et al, 2020;Ristriyani et al, 2018). Further, the quantitative findings are a theoretical consensus with the social mentality theory of self-compassion, meaning in life theory, and relational frame theory that guided this study (Frankl, 1976;Gilbert, 2017;Hayes et al, 2001;Hermanto & Zuroff, 2016).…”

“…An additional novelty of the current study is that the study was among the first to demonstrate the important predictive impact of a single model comprising self-compassion, meaning in life, and acceptance of illness; on psychological distress in PLWHAs. This is supportive of the absence of this single model in the literature (Deko et al, 2016;Hulsbosch et al, 2020;Ogueji & Okoloba, 2020).…”

“…Therefore, the mixed-method design implies that the experiences of psychological distress place limitations on the normal functioning of pregnant women living with HIV, and the significant predictors in this study may help mitigate the experiences of psychological distress among them. Additionally, the findings from this mixed-method design are argued to have endorsed the data reported in other parts of the world given the consensus in findings with studies from the Netherlands (Hulsbosch et al, 2020), Indonesia (Ristriyani et al, 2018), Brazil (Bastos et al, 2019), and the United Kingdom (O'Donovan et al, 2015).…”

mHealth Mindfulness Intervention for Women with Moderate-to-Moderately-Severe Antenatal Depressive Symptoms: a Pilot Study Within an Integrated Health Care System

“…A study conducted in China that targeted pregnant women with mild or moderate symptoms of depression and anxiety found that an Internet-based mindfulness intervention improved depression and anxiety (Yang et al 2019 ), while a UK-based study did not find a significant benefit of a Web-based intervention, mainly due to high attrition rates (22 out of 107 in intervention arm completed the study) (Krusche et al 2018 ). There are also a few other studies using Web-based mindfulness interventions that are currently underway, though the results are not yet available (Cohen and Dimidjian 2018 ; Hulsbosch et al 2020 ). The present study differs from these studies because we used a self-paced, mobile-based intervention that does not require logging into sessions at specified time.…”

Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial

“…However, the related literature for the pregnant population is sparse. Reported studies have been preliminary [ 26 - 29 ], aimed only at the postpartum period [ 30 ], treated mindfulness as a single component of a complex integrated intervention [ 31 ], or used only a pre-post test design [ 32 ]. Nevertheless, some pilot studies have supported online MBI as a promising technique to help expectant mothers reduce depressive symptoms [ 27 , 28 ].…”