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Evaluation of an Online Mindfulness-based Course for New Mothers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674124
Recruitment Status : Completed
First Posted : December 19, 2020
Last Update Posted : October 20, 2021
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Canterbury Christ Church University

Study Description
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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.

Condition or disease Intervention/treatment Phase
New Mothers Well-being Mindfulness Behavioral: Brief Online Mindfulness Intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Acceptability of an Online Mindfulness-based Intervention for Mothers Within the Postpartum Period
Actual Study Start Date : December 13, 2020
Actual Primary Completion Date : June 1, 2021
Actual Study Completion Date : July 1, 2021
Arms and Interventions
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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 Name: 10ofZen
No Intervention: Delayed course materials
Participants will have access to the course materials at the closure of their involvement in the study.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women who identify as a mother (Biological, adoptive, foster-carer or step-mum)
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674124


Locations
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United Kingdom
Canterbury Christ Church University
Tunbridge Wells, United Kingdom, TN1 2YG
Sponsors and Collaborators
Canterbury Christ Church University
University College, London
Investigators
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Principal Investigator: Nicola Pitman, BSc, MRes Canterbury Christ Church University
More Information
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Responsible Party: Canterbury Christ Church University
ClinicalTrials.gov Identifier: NCT04674124    
Other Study ID Numbers: UPID1920-0332
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No