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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.
Trials 2017; 18(1):210T

Abstract

BACKGROUND

Pregnant 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/DESIGN

The 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.

DISCUSSION

The trial is expected to contribute to the body of knowledge used in planning antenatal care for pregnant women at risk of depression.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02833519 . Registered on 19 May 2016.

Authors+Show Affiliations

Research Unit Women's and Children's Health, Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. lotte.broberg@regionh.dk. Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. lotte.broberg@regionh.dk.Research Unit Women's and Children's Health, Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.Psychiatric Research Unit, Psychiatric Centre North Zealand, Copenhagen University Hospital, Hillerød, Denmark.Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Center of Fetal Medicine, Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.Research Unit Women's and Children's Health, Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28476136

Citation

Broberg, Lotte, et al. "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." Trials, vol. 18, no. 1, 2017, p. 210.
Broberg L, Backhausen M, Damm P, et al. 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. Trials. 2017;18(1):210.
Broberg, L., Backhausen, M., Damm, P., Bech, P., Tabor, A., & Hegaard, H. K. (2017). 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. Trials, 18(1), p. 210. doi:10.1186/s13063-017-1938-z.
Broberg L, et al. 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. Trials. 2017 05 5;18(1):210. PubMed PMID: 28476136.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Broberg,Lotte, AU - Backhausen,Mette, AU - Damm,Peter, AU - Bech,Per, AU - Tabor,Ann, AU - Hegaard,Hanne Kristine, Y1 - 2017/05/05/ PY - 2016/10/27/received PY - 2017/04/11/accepted PY - 2017/5/7/entrez PY - 2017/5/10/pubmed PY - 2018/3/13/medline KW - Antenatal KW - Anxiety KW - Depression KW - Pregnancy KW - Psychological well-being KW - Randomized controlled trial KW - Supervised exercise SP - 210 EP - 210 JF - Trials JO - Trials VL - 18 IS - 1 N2 - BACKGROUND: Pregnant 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/DESIGN: The 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. DISCUSSION: The trial is expected to contribute to the body of knowledge used in planning antenatal care for pregnant women at risk of depression. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02833519 . Registered on 19 May 2016. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/28476136/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1938-z DB - PRIME DP - Unbound Medicine ER -