Evaluation of an Online Mindfulness-based Course for New Mothers

Sponsor
Canterbury Christ Church University (Other)
Overall Status
Completed
CT.gov ID
NCT04674124
Collaborator
University College, London (Other)
112
1
2
6.6
17

Study Details

Study Description

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
  • Behavioral: Brief Online Mindfulness Intervention
N/A

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

Study Type:
Interventional
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 :
Dec 13, 2020
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

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.

    Outcome Measures

    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 [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:
    • 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

    Locations

    Site City State Country Postal Code
    1 Canterbury Christ Church University Tunbridge Wells United Kingdom TN1 2YG

    Sponsors and Collaborators

    • Canterbury Christ Church University
    • University College, London

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Canterbury Christ Church University
    ClinicalTrials.gov Identifier:
    NCT04674124
    Other Study ID Numbers:
    • UPID1920-0332
    First Posted:
    Dec 19, 2020
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 20, 2021