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Evaluation of an Online Mindfulness-based Course for New Mothers

Feasibility and Acceptability of an Online Mindfulness-based Intervention for Mothers Within the Postpartum Period

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04674124
Enrollment
112
Registered
2020-12-19
Start date
2020-12-13
Completion date
2021-07-01
Last updated
2021-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mindfulness, New Mothers Well-being

Brief summary

This research study is aiming to explore whether an online mindfulness programme is accessible and supportive for first time mothers who has a child who is less than 12 months old.

Detailed description

This study is a randomised controlled trial (RCT) comparing an online mindfulness based course (10ofZen) with a treatment as usual group (delayed 10ofZen course materials). Participants will be informed about the study and asked to undertake a screening questionnaire to ensure the eligibility criteria is met. Following this, participants will be invited to give online consent. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 10) and at follow-up (week 14). A sleep measure will also be undertaken and used as a co-variate during data analysis. At the end of participation in the research study, all participants will gain access to the course materials, including audio recordings of meditations and any written materials used within the course.

Interventions

BEHAVIORALBrief Online Mindfulness Intervention

A nine-week mindfulness course compromising of 9x weekly 15 minute group sessions which will be on an online platform and daily micro meditations for participants to undertake.

Sponsors

University College, London
CollaboratorOTHER
Canterbury Christ Church University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Women who identify as a mother (Biological, adoptive, foster-carer or step-mum) * Have an infant under the age of 12 months at baseline measures * Sufficient English reading and listening abilities * Access to the internet via an electronic device (phone, tablet, laptop or computer) * Access to a mobile phone * No prior experience of parenting a baby (under 12 months of age)

Exclusion criteria

* Previous completion of a formal 8-week mindfulness course or current mindfulness/meditation practice * Currently pregnant * Severe levels of depression and/or anxiety as measured by 15+ point on the Generalised Anxiety Disorder-7 and Patient Health Questionnaire-9 (NICE, 2011). * Suicidal ideation or thoughts of self-harm in the last two weeks * Currently experiencing symptoms of psychosis * Diagnosis of Post Traumatic Stress Disorder (PTSD) * Bereavement within the last six months which they still feel affected by.

Design outcomes

Primary

MeasureTime frameDescription
Differences in scores between groups at post intervention (10) and follow up (14) on the Short Warwick-Edinburgh Mental Well-Being ScalePost-intervention and follow up ( i.e 10 & 14 weeks post baseline)Self-report measure of perceived well-being. Scores can range from 0-35. Higher scores are indicative of higher levels of subjective wellbeing.

Secondary

MeasureTime frameDescription
Differences in scores between groups at post intervention (10) and follow up (14) on the Maternal Postnatal Attachment ScalePost-intervention ( i.e 10 & 14 weeks post baseline)Self-report measure of maternal emotional bond to the infant. Scores range from 0-95. Higher scores are indicative of higher levels of maternal emotional attachment.
Differences in scores between groups at post intervention (10) and follow up (14) on the Depression Anxiety Stress Scale - 21Post-intervention ( i.e 10 & 14 weeks post baseline)Self-report measure of depression, anxiety and stress. Scores range from 0-63 with higher scores being indicative of higher levels of depression, anxiety and/or stress.
Differences in scores between groups at post intervention (10) and follow up (14) Five Facet Mindfulness Questionnaire - 15Post-intervention ( i.e 10 & 14 weeks post baseline)Self-report measure of mindfulness traits. Scores can range between 15-75 with higher scores being indicative of higher levels of mindfulness traits.
Differences in scores between groups at post intervention (10) and follow up (14) on sleep qualityPost-intervention ( i.e 10 & 14 weeks post baseline)Self report measures on sleep quality ranging from 0 (very poor) to 10 (excellent)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026