Evaluation of an Online Mindfulness-based Course for New Mothers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mindfulness, New Mothers Well-being

Intervention / Treatment
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* Behavioral: Brief Online Mindfulness Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | Self report measures on sleep quality ranging from 0 (very poor) to 10 (excellent) | Post-intervention ( i.e 10 & 14 weeks post baseline) |