CClinicalTrials.gg
CompletedNCT04674124Updated Oct 20, 2021

Evaluation of an Online Mindfulness-based Course for New Mothers

An interventional study of Brief Online Mindfulness Intervention in New Mothers Well-being and Mindfulness, sponsored by Canterbury Christ Church University. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-20.

Sponsored by Canterbury Christ Church University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • New Mothers Well-being
  • Mindfulness
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In context

Lead sponsor

Canterbury Christ Church University is the lead sponsor of 27 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    Online Mindfulness Course

    Participants will be enrolled on a 9 week online mindfulness course.

    Behavioral: Brief Online Mindfulness Intervention

  • No intervention
    Delayed course materials

    Participants will have access to the course materials at the closure of their involvement in the study.

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.

    Also known as: 10ofZen

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What researchers measure

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

    Self-report measure of perceived well-being. Scores can range from 0-35. Higher scores are indicative of higher levels of subjective wellbeing.

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

Secondary outcomes

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

    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.

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

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

    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.

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

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

    Self-report measure of mindfulness traits. Scores can range between 15-75 with higher scores being indicative of higher levels of mindfulness traits.

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

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

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

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

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Study locations

1 site
  • Canterbury Christ Church University
    Tunbridge Wells, TN1 2YG, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04674124
Lead sponsor
Canterbury Christ Church University
Collaborators
University College, London
Responsible party
Sponsor
First posted
Dec 19, 2020
Start date
Dec 13, 2020
Primary completion
Jun 1, 2021
Completion
Jul 1, 2021
Last update
Oct 20, 2021

Study contacts

Nicola Pitman, BSc, MRes
principal investigator · Canterbury Christ Church University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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