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

Pregnancy Related Clinical Trial

— PRENAYOGA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05824208
• Other study ID #: HR/DP-22/23-34528
• Status: Completed
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: June 17, 2023

Study information

• Verified date: March 2023
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 17, 2023
• Est. primary completion date: June 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Gestational age: week 20 of gestation or over, at the first session.

• Over 18 years of age.

• Basic understanding of English.

• Able to travel to the sessions.

• Belonging to an ethnic minority group (self-identified) other than White.

Exclusion Criteria:

• Physical or mental health diagnosis that would prevent them from attending yoga sessions, as per their healthcare professional's advice (self-reported).

Related Conditions & MeSH terms

• Complementary
• Pregnancy Related
• Prenatal Stress

Intervention

Behavioral:
• PRENAYOGA - prenatal yoga
The intervention is a prenatal yoga module developed for prenatal women. Intervention details: bi-weekly yoga classes (60 minutes of duration) 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.

Locations

Country	Name	City	State
United Kingdom	Maurice Wohl Clinical Neuroscience Institute, 5 Cutcombe Rd, Brixton, London SE5 9RT	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the acceptability of the intervention	Total score of the Acceptability of Intervention Measure (AIM). The Acceptability of Intervention Measure (AIM) has a scale range of 1-5, with higher scores indicating greater acceptability.	End of intervention (week 8).
Secondary	To assess reasons for perceived acceptability of the intervention	Focus groups	End of intervention (week 8).
Secondary	To assess uptake/reach of the intervention	Number of eligible women that sign up to the intervention	End of intervention (week 8).
Secondary	To assess the appropriateness of the intervention	Total score of the Intervention Appropriateness Measure (IAM). The Intervention Appropriateness Measure (IAM) has a scale range of 1-5, with higher scores indicating greater appropriateness of the intervention.	End of intervention (week 8).
Secondary	To assess the feasibility of the intervention	Total score of the Feasibility of Intervention Measure (FIM). FIM has a scale range of 1-5, higher scores indicate greater feasibility of the intervention, assessing the practicality and potential for success of an intervention in a particular setting or population based on factors such as ease of implementation, cost-effectiveness, and stakeholder acceptability.	End of intervention (week 8).
Secondary	To assess intervention adherence and attrition rates	Data on the overall adherence to the intervention, number of drops-outs each week.	End of intervention (week 8).
Secondary	To assess the effects of quality of life	EQ5D-5L (quality of life measure). The EQ5D-5L is a quality of life measure that can be presented as EQ VAS and EQ-5D-5L index value.	Start (baseline) and end of intervention (week 8).
Secondary	To assess factors affecting the sustainability and scalability of the intervention	Focus groups	End of intervention (week 8).
Secondary	To assess the effectiveness of group prenatal yoga to increase mother-foetal attachment	Exploratory investigation of the Maternal Foetal Attachment Scale. The Maternal Foetal Attachment Scale has 24 items. The items are scored on a five-point scale (1-5) with a total score ranging from 24 to 120, with higher scores indicating greater maternal-foetal attachment.	Start (baseline) and end of intervention (week 8).
Secondary	To assess the effectiveness of group prenatal yoga to increase mother-foetal attachment	Exploratory investigation of the Maternal Antenatal Attachment Scale. The Maternal Antenatal Attachment Scale has a scale range of 1-5 with a total score ranging from 19-95, with higher scores indicating greater maternal antenatal attachment.	Start (baseline) and end of intervention (week 8).
Secondary	To assess whether yoga improves further aspects of mental health	The Edinburgh Postnatal Depression Scale (EPDS). The Edinburgh Postnatal Depression Scale (EPDS) has a range of 0-3, with a scale total range of 0-30, where higher scores indicate greater depressive symptoms.	Start (baseline) and end of intervention (week 8).
Secondary	To assess whether yoga improves further aspects of mental health	Beck Depression Inventory (BDI). The Beck Depression Inventory (BDI) has a scale range of 0-63, with higher scores indicating greater depressive symptoms. Each answer is scored on a scale value of 0-3.	Start (baseline) and end of intervention (week 8).
Secondary	To assess whether yoga improves further aspects of mental health	State and Train Anxiety Inventory (STAI). The State and Trait Anxiety Inventory (STAI) is rated on a 4-point Likert scale and has a total scale range of 20-80, with higher scores indicating greater anxiety symptoms.	Start (baseline) and end of intervention (week 8).
Secondary	To assess whether yoga improves further aspects of mental health	Perceived Stress Scale (PSS). The PSS questionnaire typically contains 10 questions, and respondents rate their feelings and thoughts over the past month on a 5-point scale. The Perceived Stress Scale (PSS) has a scale range of 0-40, where higher scores indicate greater perceived stress.	Start (baseline) and end of intervention (week 8).
Secondary	To ascertain whether yoga affects mother-infant bond (postpartum)	Maternal Attachment Inventory (MAI). The Maternal Attachment Inventory (MAI) has a scale range of 22-88, with higher scores indicating greater maternal attachment.	Start (baseline) and end of intervention (week 8).
Secondary	To ascertain whether yoga improves social support and efficacy	Multidimensional Scale of Perceived Social Support (MSPSS). The Multidimensional Scale of Perceived Social Support (MSPSS) has a total scale range of 12-84 or subscale ranges of 3-7, with higher scores indicating greater perceived social support.	Start (baseline) and end of intervention (week 8).
Secondary	To ascertain whether yoga improves social support and efficacy	The Short General Self-Efficacy Scale (GSE-6). The Short General Self-Efficacy Scale (GSE-6) has a scale range of 6-30, with higher scores indicating greater general self-efficacy.	Start (baseline) and end of intervention (week 8).
Secondary	To identify how the yoga sessions affect the lived experience of ethnic minority pregnant women	Focus groups	End of intervention (week 8).
Secondary	To identify how the yoga sessions are perceived by the yoga teachers	Interviews	End of intervention (week 8).
Secondary	To assess the effectiveness of group prenatal yoga to increase mother-foetal attachment	Changes in scores of the Prenatal Attachment Inventory. The Prenatal Attachment Inventory has 21 items and is a scale ranging from 21-84, with higher scores indicating greater prenatal attachment.; items	Start (baseline) and end of intervention (week 8).