PRENAYOGA: Exploratory Feasibility Study of Bi-weekly Pregnancy Yoga-based Sessions for Ethnic Minority Women — PRENAYOGA  

Pregnancy Related Clinical Trial

Official title: PRENAYOGA: Exploratory Feasibility Study of Bi-weekly Pregnancy Yoga-based Sessions for Ethnic Minority Women

Status Completed

Clinical Trial Summary

Depression and anxiety are the most prevalent psychiatric disorders in the perinatal period. A recent report found that nearly 50% of new mothers in London (where 40% of the population is of ethnic minority background) display symptoms of postnatal depression (PND).

A 2022 report by the London School of Economics (LSE) found that treating maternal mental illness could save the National Health Service (NHS) £52 million over 10 years; in 2014, the LSE calculated that two-thirds of that cost is linked to adverse child development.

Prenatal depression results in adverse outcomes for the mother and infant, which are also linked to the impact of postnatal depression on the emotional relationship and attachment between the mother and the child. The major risk for developing depression postnatally is a history of depression, either in the lifetime or during pregnancy.

Several studies highlight that antenatal depression rates are higher in ethnic minority women. However, the percentage of ethnically diverse women in most studies on perinatal depression is negligible. Additionally, ethnic minority women are less represented in perinatal mental health therapeutic settings.

Preliminary evidence indicates prenatal yoga reduces anxiety and depression and improves mother-foetal attachment. Ethnic minorities support mind-body interventions such as yoga and may be more likely to engage in community-based activities than traditional antenatal classes.

An 8-week feasibility study will assess the feasibility and acceptability of a yoga-based intervention for ethnic minority women in London.

Clinical Trial Description

This exploratory feasibility study intends to understand participants' experiences and implementation considerations of an evidence-based, stakeholder-co-designed prenatal yoga intervention.

Participants will be recruited through signposting in the community and social media. Potential participants will complete an online form store on the study-specific SharePoint where they will include their name, date of birth, due date, mobile number, e-mail address, home address, GP/midwife contact details, frequency of previous yoga practice and availability for the study. This information will allow researchers to assess for eligibility and gather contact details for baseline assessment. The ICF and PIS will be sent to participants who fulfil the eligibility criteria. If participants do not enrol on the study, their information will be deleted.

Once they agree to be part of the study and basic demographics are collected on Zoom, participants will be sent, via e-mail, questionnaires to complete (on their phones or laptops) to evaluate their mental health, social support and attachment to the baby. These questionnaires are surveys that can be answered quickly and allow researchers to quantify changes in psychological states over time. Implementation questionnaires to understand how the intervention can be tested in future large-scale studies will also be collected on REDCap. Attendance and enrolment rates will also be collected for adherence and uptake implementation measures.

Questionnaires will be again completed at week 4 (midpoint of the study), week 8 (end of study), at 8 weeks postpartum and 6 months postpartum. There will be a 2-week leeway for questionnaire completion by participants.

Salivary cortisol samples will be collected at the beginning and end of sessions 1 and 8 to assess in-person changes in cortisol outputs during the yoga sessions.

Changes in participants' depression, anxiety, social support, maternal-foetal attachment and cortisol levels will be quantified to understand if the yoga programme may impact these aspects.

Participants will be asked to provide qualitative data on their views of the intervention and the study in the following formats:

• Focus group in the last week of the study on the experience of the intervention and barriers/facilitators

• Interviews with participants who attend less than 50% of sessions or withdraw from the study on their experience of the intervention and barriers/facilitators of the intervention.

Interviews and focus groups are optional (this is mentioned in the PIS and ICF).

Questions for focus groups and interviews will be around the overall experience of the intervention, expectations, acceptability, reasons for missed sessions, adoption, preference for sessions in person/online, willingness to undergo randomisation on an RCT, and acceptability of the questionnaires and samples. In the focus groups, I will also ask about facilitators and barriers, the appropriateness of the sessions, how feasible it was for them to attend the sessions and any factors that may affect the long-term scalability/sustainability of the yoga sessions.

Intervention: bi-weekly yoga classes (60 minutes duration, twice per week) will be delivered in person in a yoga studio in London for 8 consecutive weeks. Participants will be provided with yoga mats, blocks, bolsters and yoga straps at the studio. The class will be adapted to pregnancy and for all levels of ability, focusing on slow movements and body awareness. The content of the class will include loosening exercises (warm-up exercises), simple postures (standing, balancing, sitting, kneeling, supine and restorative poses), breathing exercises and meditation. Classes will be delivered by an internationally certified and trained yoga teacher and will be accompanied by soft instrumental music. ;

Related Conditions & MeSH terms

• Complementary
• Pregnancy Related
• Prenatal Stress

• NCT number: NCT05824208
• Study type: Interventional
• Source: King's College London
• Status: Completed
• Phase: N/A
• Start date: March 28, 2023
• Completion date: June 17, 2023