Effect of supervised exercise in groups on psychological well-being among pregnant women at risk of depression (the EWE Study): study protocol for a randomized controlled trial

Abstract

BackgroundPregnant women with depression and/or anxiety prior to pregnancy are at higher risk of preterm birth, breastfeeding problems, postpartum depression, and disruption of the mother-infant attachment. It is well documented that exercise improves psychological well-being in nonpregnant subjects with symptoms of depression. However, in only a few small studies have researchers examined the effect of exercise on symptoms of depression among pregnant women. We hypothesize that physiotherapist-supervised group exercise for pregnant women at risk of antenatal depression increases their psychological well-being. This paper describes the study protocol of a randomized controlled trial (RCT) on a supervised group exercise intervention for pregnant women with a current or previous history of depression and/or anxiety.Methods/designThe RCT is being carried out at the Department of Obstetrics, Rigshospitalet, Copenhagen University Hospital, in the period 2016–2019. The inclusion criteria are pregnant women ≥18 years of age with depression and/or anxiety requiring treatment by a psychiatrist or a psychologist within the last 10 years and/or intake of antidepressants in the 3 months prior to conception and/or during pregnancy. The women must have appropriate Danish language skills, be pregnant with a single fetus, give written informed consent, and be at 17–22 gestational weeks when the intervention begins. The primary outcome is psychological well-being (the five-item World Health Organization Well-being Index). Secondary outcomes are symptoms of depression (Edinburgh Postnatal Depression Scale), functional ability (General Health Questionnaire), clinical symptoms of anxiety (State-Trait Anxiety Inventory), sleep quality and sleep disturbances (Pittsburgh Sleep Quality Index), and pregnancy and delivery outcomes. The intervention is supervised group exercise twice weekly for 12 weeks. The control group will receive standard antenatal care. On the basis of sample size calculation, a total of 300 women will be randomly assigned to either the intervention or the control group in a ratio of 1:1.DiscussionThe trial is expected to contribute to the body of knowledge used in planning antenatal care for pregnant women at risk of depression.Trial registrationClinicalTrials.gov, NCT02833519. Registered on 19 May 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1938-z) contains supplementary material, which is available to authorized users.

Well-being in high-risk pregnancy: an integrative review

“…A pregnant woman with HRP may feel threat due to her fear and concern over the adverse outcomes of pregnancy and uncertainty about pregnancy outcomes. In other words, well-being in HRP largely depends on feelings of safety and security (36,41,42,66). Safety is also a key component of well-being in other disciplines (56,67,68).…”

Effect of supervised group Exercise on psychological WEll-being among pregnant women with or at high risk of depression (the EWE Study): a randomised controlled trial

“…: 2012-58-0004) approved the study. The study was registered at ClinicalTrials.gov (NCT02833519), and a detailed study protocol has been published (19).…”

“…Pregnant women with a current or previous history of depression and/or anxiety who were interested in participating were invited to a face-to-face visit with a research midwife (19). All participants provided written informed consent and completed a self-administered electronic baseline questionnaire.…”

“…Women fulfilling these criteria but with a chronic disease were only included in the study after prior agreement with their obstetrician. Participants were withdrawn from the intervention after randomisation for the following reasons: development of pelvic girdle syndrome, preeclampsia, vaginal bleeding, or symptoms of preterm labour contraindicating physical activity (19).…”

“…The exercise intervention was developed and supervised by four physiotherapists from Rigshospitalet in accordance with the Danish national recommendations for exercise during pregnancy (21). The intervention is described in details in the study protocol (19).…”