NCT04674124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

December 14, 2020

Last Update Submit

October 12, 2021

Conditions

New Mothers Well-beingMindfulness

Outcome Measures

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.

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

Secondary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (2)

Online Mindfulness Course

EXPERIMENTAL

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

Behavioral: Brief Online Mindfulness Intervention

Delayed course materials

NO INTERVENTION

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

Interventions

Brief Online Mindfulness InterventionBEHAVIORAL

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
Online Mindfulness Course

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who identify as a mother (Biological, adoptive, foster-carer or step-mum)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canterbury Christ Church University

Royal Tunbridge Wells, TN1 2YG, United Kingdom

Location

Study Officials

  • Nicola Pitman, BSc, MRes

    Canterbury Christ Church University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 19, 2020

Study Start

December 13, 2020

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

October 20, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)