NCT05824208

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2023

Completed
Last Updated

September 14, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 24, 2023

Last Update Submit

September 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (19)

  • To assess reasons for perceived acceptability of the intervention

    End of intervention (week 8).

  • To assess uptake/reach of the intervention

    End of intervention (week 8).

  • To assess the appropriateness of the intervention

    End of intervention (week 8).

  • To assess the feasibility of the intervention

    End of intervention (week 8).

  • To assess intervention adherence and attrition rates

    End of intervention (week 8).

  • +14 more secondary outcomes

Study Arms (1)

Bi-weekly pregnancy yoga-based sessions for 8 weeks

EXPERIMENTAL
Behavioral: PRENAYOGA - prenatal yoga

Interventions

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.

Bi-weekly pregnancy yoga-based sessions for 8 weeks

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maurice Wohl Clinical Neuroscience Institute, 5 Cutcombe Rd, Brixton, London SE5 9RT

London, SE5 9RT, United Kingdom

Location

Related Publications (1)

  • Estevao C, Chiarpenello C, Kwok W, Bhargav H, Jasti N, Chandra P, Varambally S, Pariante C. Co-designing and evaluating a prenatal yoga intervention for ethnic minority women: a feasibility study. Pilot Feasibility Stud. 2025 Jul 7;11(1):96. doi: 10.1186/s40814-025-01667-9.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 21, 2023

Study Start

March 28, 2023

Primary Completion

June 3, 2023

Study Completion

June 17, 2023

Last Updated

September 14, 2023

Record last verified: 2023-03

Locations