Abstract
BackgroundClinically significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression. Untreated psychological distress in pregnancy is associated with poor obstetrical outcomes, changes in maternal physiology, elevated incidence of child physical and psychological disorders, and is predictive of maternal postpartum mood disorders. Despite the wide-ranging impact of antenatal psychological distress on mothers and their children, there is a gap in our knowledge about the most effective treatments that are available for psychological distress experienced in pregnancy. Additionally, no trials have focused on potential physiological changes that may occur as a result of receiving mindfulness training in pregnancy. The proposed trial will determine the effectiveness of an 8-week modified Mindfulness-based Cognitive Therapy (MBCT) intervention delivered during pregnancy.MethodsA randomized controlled trial (RCT) design with repeated measures will be used to evaluate the effectiveness of MBCT to treat psychological distress in pregnancy. A sample of 60 consenting pregnant women aged 18 years and above will be enrolled and randomized to the experimental (MBCT) or control (treatment as usual) condition. Primary (e.g., symptoms of stress, depression, and anxiety), secondary (cortisol, blood pressure (BP), heart rate variability (HRV), and sleep) and other outcome data (e.g., psychological diagnoses) will be collected via a combination of laboratory visits and at-home assessments from both groups at baseline (T1), immediately following the intervention (T2), and at 3 months postpartum (T3). Descriptive statistics will be used to describe sample characteristics. Data will be analyzed using an intention-to-treat approach. Hierarchical linear models will be used to test intervention effects on primary and secondary outcomes.DiscussionThe trial is expected to improve knowledge about evidence-based treatments for psychological distress experienced in pregnancy and to evaluate the potential impact of mindfulness-based interventions on maternal physiology.Trial registrationClinicalTrials.gov: NCT02214732, registered on 7 August 2014.Protocol Version 2.0., 5 September 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1601-0) contains supplementary material, which is available to authorized users.
Highlights
MethodsA randomized controlled trial (RCT) design with repeated measures will be used to evaluate the effectiveness of Mindfulness-based Cognitive Therapy (MBCT) to treat psychological distress in pregnancy
Significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression
Among the current evidence-based interventions, Mindfulness-based Cognitive Therapy (MBCT) was selected in this study because research suggests that it can effectively reduce current symptoms of stress and anxiety and may help in preventing recurrence of depression – an important consideration when working with a population of women whose antenatal psychological distress puts them at high risk for developing a postpartum mood disorder
Summary
Study design The study is a two-arm, single-blinded, parallel-group RCT with equal allocation of participants and a repeated measure design. Physiological measures will be obtained, including assessments of BP, heart rate variability (HRV), and a stress reactivity task. Participants are briefed with the information included in the pamphlet and informed about the perinatal support contacts should they choose to pursue treatment options Both groups All participants who come to the laboratory will complete baseline (T1) measures prior to randomization. At each of the three visits (baseline, post-treatment and, follow-up), participants from both groups will complete two stress tasks: a mental arithmetic and a Stroop task [64]. The current study design has a number of strengths, including: (1) interviewer-assessed clinical diagnosis of psychological disorders, (2) longitudinal study design with follow-up that extends into the postpartum period, and (3) extensive physiological testing, including assessment of BP, HRV, stress reactivity, HPA function, and sleep.
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