Evaluation of an Online Mindfulness-based Course for New Mothers

Not Applicable

Completed

• Conditions: Mindfulness; New Mothers Well-being
• Interventions: Behavioral: Brief Online Mindfulness Intervention

• Registration Number: NCT04674124
• Lead Sponsor: Canterbury Christ Church University

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.

Study Timeline

• Study Start: 2020-12-13
• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Primary Completion: 2021-06-01
• Study Completion: 2021-07-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online Mindfulness Course	Brief Online Mindfulness Intervention	Participants will be enrolled on a 9 week online mindfulness course.

Primary Outcome Measures

Name	Time	Method
Differences in scores between groups at post intervention (10) and follow up (14) on the Short Warwick-Edinburgh Mental Well-Being Scale	Post-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 Outcome Measures

Name	Time	Method
Differences in scores between groups at post intervention (10) and follow up (14) on the Maternal Postnatal Attachment Scale	Post-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 - 21	Post-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 - 15	Post-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 quality	Post-intervention ( i.e 10 & 14 weeks post baseline)	Self report measures on sleep quality ranging from 0 (very poor) to 10 (excellent)

Trial Locations

Locations (1)

Canterbury Christ Church University; 🇬🇧 Tunbridge Wells, United Kingdom