Feasibility and Acceptability of an Online Mindfulness-based Intervention for Mothers Within the Postpartum Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Differences in scores between groups at post intervention (10) and follow up (14) on the Short Warwick-Edinburgh Mental Well-Being Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Differences in scores between groups at post intervention (10) and follow up (14) on the Short Warwick-Edinburgh Mental Well-Being Scale
时间窗: 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.
次要结局
- 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))