Clinical trial NCT04674124: Evaluation of an Online Mindfulness-based Course for New Mothers
Official title: Feasibility and Acceptability of an Online Mindfulness-based Intervention for Mothers Within the Postpartum Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: New Mothers Well-being
Mindfulness
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2020-12-19
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Differences in scores between groups at post intervention (10) and follow up (14) on the Short Warwick-Edinburgh Mental Well-Being Scale
timeFrame: Post-intervention and follow up ( i.e 10 & 14 weeks post baseline)
Secondary outcomes:
measure: Differences in scores between groups at post intervention (10) and follow up (14) on the Maternal Postnatal Attachment Scale
timeFrame: Post-intervention ( i.e 10 & 14 weeks post baseline)
measure: Differences in scores between groups at post intervention (10) and follow up (14) on the Depression Anxiety Stress Scale - 21
timeFrame: Post-intervention ( i.e 10 & 14 weeks post baseline)
measure: Differences in scores between groups at post intervention (10) and follow up (14) Five Facet Mindfulness Questionnaire - 15
timeFrame: Post-intervention ( i.e 10 & 14 weeks post baseline)
measure: Differences in scores between groups at post intervention (10) and follow up (14) on sleep quality
timeFrame: Post-intervention ( i.e 10 & 14 weeks post baseline)
Other outcomes:
Locations:
city: Tunbridge Wells
country: United Kingdom
facility: Canterbury Christ Church University
Study officials:
affiliation: Canterbury Christ Church University
name: Nicola Pitman, BSc, MRes
role: PRINCIPAL_INVESTIGATOR
References: