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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.

ABSTRACT: 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.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.The trial is expected to contribute to the body of knowledge used in planning antenatal care for pregnant women at risk of depression.ClinicalTrials.gov, NCT02833519 . Registered on 19 May 2016.

SUBMITTER: Broberg L

PROVIDER: S-EPMC5420113 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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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.

Broberg Lotte L Backhausen Mette M Damm Peter P Bech Per P Tabor Ann A Hegaard Hanne Kristine HK

Trials 20170505 1

<h4>Background</h4>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 physiot ...[more]

PMID: 28476136

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Project description:In the context of physical activity and sport, perfectionism and the regular practice of physical activity are related to psychological well-being and the regulation of psychological resources necessary for adaptation to effort and satisfaction. At the same time, the most active students are also those who show greater appetites for physical education classes. The goal of this work was to identify the influence of perfectionist beliefs and the regularity of the practice of physical exercise on psychological well-being. The participants were adolescents (n = 436) aged between 14 and 19 years (M = 16.80, SD = .77). They were administered the Multidimensional Perfection Scale, the Psychological Wellbeing Scale, the Global Physical Activity Questionnaire (GPAQv2), and a sociodemographic questionnaire. The results showed, under a non-random and transversal design, that the participants gave important value to physical exercise because they feel both active and vigorous. Regarding perfectionism, the functional aspects of perfectionism (expectations of achievement and organization) correlated positively, while the dysfunctional aspects (fear of committing errors and external expectations) did so negatively with the importance given to physical exercise performed by adolescents; this in turn positively predicted psychological well-being. In this way, the hypothesized model contemplated the relevance of the included variables and reflected the mediation of the degree of importance given to the practice of physical exercise on perfectionist beliefs and psychological well-being. Currently, most physical activity practice proposals for adolescents focus on federated and structured environments for competition, and those that deal with recreational and health-oriented sports are far less common. Hence, "the perfect way of doing sports" for a teenager should be accompanied by cognitive schemes aimed at strengthening psychological resources that allow the regulation of beliefs, attitudes, and behaviors.

Project description:OBJECTIVES:Women with high body mass index (BMI) have increased risk for symptoms of anxiety and depression during pregnancy and postpartum. In this prespecified secondary analysis from the exercise training in pregnancy trial, our aim was to examine effects of supervised exercise during pregnancy on psychological well-being in late pregnancy and postpartum among women with a prepregnancy BMI ?28?kg/m2. DESIGN:Single-centre, parallel group, randomised controlled trial. SETTING:University Hospital, Norway. PARTICIPANTS:Ninety-one women (age 31.2±4.1 years, BMI 34.5±4.2?kg/m2), 46 in the exercise group, 45 in the control group, were included in the trial. INTERVENTION:The exercise group was offered 3?weekly supervised exercise sessions (35?min of moderate intensity walking/running and 25?min of resistance training), until delivery. PRIMARY AND SECONDARY OUTCOMES MEASURES:Primary analyses were based on intention to treat, with secondary perprotocol analyses. To assess psychological well-being, we used the 'Psychological General Well-Being Index' (PGWBI) at inclusion (gestational week 12-18), late pregnancy (gestational week 34-37) and 3?months postpartum. We assessed postpartum depression using the 'Edinburgh Postnatal Depression Scale' (EPDS). RESULTS:Numbers completed data collection: late pregnancy 72 (exercise 38, control 36), postpartum 70 (exercise 36, control 34). In the exercise group, 50% adhered to the exercise protocol. Baseline PGWBI for all women was 76.4±12.6. Late pregnancy PGWBI; exercise 76.6 (95% CI 72.2 to 81.0), control 74.0 (95% CI 69.4 to 78.5) (p=0.42). Postpartum PGWBI; exercise 85.4 (95% CI 81.9 to 88.8), control 84.6 (95% CI 80.8 to 88.4) (with no between-group difference, p=0.77). There was no between-group difference in EPDS; exercise 2.96 (95% CI 1.7 to 4.2), control 3.48 (95% CI 2.3 to 4.7) (p=0.55). CONCLUSIONS:We found no effect of supervised exercise during pregnancy on psychological well-being among women with high BMI. Our findings may be hampered by low adherence to the exercise protocol. TRIAL REGISTRATION NUMBER:NCT01243554.

Project description:Background: Aerobic exercise (AE) may be a non-pharmacological strategy to improve depression treatment and lessen the burden of somatic comorbidity of depression. Only few studies have examined the effect of AE as an add-on treatment for moderate to severe depression in an inpatient setting, and most studies have focused on depression severity and cardiovascular parameters. The purpose of the present article is to present the study protocol, to provide information about the assessed study population, and to perform a manipulation check in order to examine whether the intervention program was properly implemented. Methods: We conducted a randomized controlled trial in two centers comparing 6 weeks of AE to a placebo control intervention (stretching) as an add-on to standardized inpatient treatment of moderate to severe depression. Besides depression severity, several other psychological and biological variables were measured such as salivary cortisol, brain-derived neurotropic factor, cognitive tests, and polysomnography. To evaluate long-term effects of the intervention, we also scheduled a follow-up 6 months after completion of the study intervention. Results: Forty-five patients were randomized to either AE (n = 23) or the placebo intervention (n = 22); 36 patients completed the 6-week intervention. In the AE group, 65% completed all 18 training sessions. Patients who were less physically active prior to admission were less likely to complete the study. With regard to energy expenditure, mean kcal/kg/week was 16.4 kcal/kg/week (range: 13.8-17.7), coming close to the targeted dose of 17.5 kcal/kg/week. Conclusions: Overall, patients showed good adherence to the intervention protocol despite at least moderate depression severity. However, the dropout rate suggests that depressed inpatients may need special support to adhere to a structured exercise intervention program. This study will add evidence on the effects of AE as an add-on to inpatient treatment of moderate to severe depression. Besides antidepressant effects, potentially beneficial effects of AE on a broad array of further variables associated with depression will be evaluated. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02679053.

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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.

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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.

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