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Completed

NCT Number: NCT04674124

Evaluation of an Online Mindfulness-based Course for New Mothers

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.

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Key information

Conditions

New Mothers Well-being Mindfulness

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Canterbury Christ Church University

Royal Tunbridge Wells, TN1 2YG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief Online Mindfulness Intervention

Behavioral

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.

Other names: 10ofZen

Primary outcomes

  1. Differences in scores between groups at post intervention (10) and follow up (14) on the Short Warwick-Edinburgh Mental Well-Being Scale

    Time frame: 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 outcomes

  1. Differences in scores between groups at post intervention (10) and follow up (14) on the Maternal Postnatal Attachment Scale

    Time frame: 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.

  2. Differences in scores between groups at post intervention (10) and follow up (14) on the Depression Anxiety Stress Scale - 21

    Time frame: 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.

  3. Differences in scores between groups at post intervention (10) and follow up (14) Five Facet Mindfulness Questionnaire - 15

    Time frame: 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.

  4. Differences in scores between groups at post intervention (10) and follow up (14) on sleep quality

    Time frame: Post-intervention ( i.e 10 & 14 weeks post baseline)

    Self report measures on sleep quality ranging from 0 (very poor) to 10 (excellent)

Sponsors and collaborators

Lead sponsor

Canterbury Christ Church University

Other

Collaborators

  • University College, London

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2020
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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