Evaluation of an Online Mindfulness-based Course for New Mothers

October 12, 2021 updated by: Canterbury Christ Church University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Tunbridge Wells, United Kingdom, TN1 2YG
        • Canterbury Christ Church University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online Mindfulness Course
Participants will be enrolled on a 9 week online mindfulness course.
Behavioral: Brief 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.
Other Names:
  • 10ofZen
No Intervention: Delayed course materials
Participants will have access to the course materials at the closure of their involvement in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-intervention and follow up ( i.e 10 & 14 weeks post baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-intervention ( i.e 10 & 14 weeks post baseline)
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.
Post-intervention ( i.e 10 & 14 weeks post baseline)
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.
Post-intervention ( i.e 10 & 14 weeks post baseline)
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)
Post-intervention ( i.e 10 & 14 weeks post baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canterbury Christ Church University

Collaborators

University College, London

Investigators

  • Principal Investigator: Nicola Pitman, BSc, MRes, Canterbury Christ Church University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • UPID1920-0332

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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