Feasibility Study Investigating the Efficacy and Acceptability of a Pregnancy Focussed Online Cognitive Behavioural Therapy Package: Enjoy Your Bump
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Estimation of effect size for changes in depression.
研究概览
简要总结
A feasibility study evaluating how acceptable women experiencing low mood or anxiety during their pregnancy find an online Cognitive Behavioural Therapy course called 'Enjoy Your Bump'. This project will also begin to explore the effectiveness of this programme as a low intensity self-help intervention for mild to moderate depressive symptoms during pregnancy.
详细描述
'Enjoy Your Bump (EYB)' is an online life skills course based on Cognitive Behavioural Therapy (CBT) principles which has been designed to specifically support women in the antenatal period. A survey of women and health professionals has demonstrated that this is a resource that both groups find acceptable. The aim of this quasi-experimental feasibility study is to evaluate the user experience and efficacy of this online programme as a non-pharmacological, low intensity intervention for women experiencing mild-moderate depressive symptoms in pregnancy. This will be achieved by measuring depression and anxiety as well as measures of attachment to the developing baby, pre and post intervention. It is hoped the results from this study will help inform whether this is a resource that should be made more widely available to women in the National Health Service (NHS). It is hypothesised that the 'Enjoy Your Bump' will be an acceptable and effective intervention for women experiencing mild to moderate depressive symptoms in the antenatal period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •Mild-moderate chronic perinatal mental health identified by a score of 2 or higher on PHQ-2 and/or GAD-
- •16+0 to 32+6 weeks at recruitment
排除标准
- •Severe perinatal mental health problem such as schizophrenia, bipolar disorder, substance abuse/dependence, active risk of self-harm.
- •Already receiving psychological therapy.
- •Insufficient English language to engage with intervention or complete questionnaires.
- •Unable to give informed consent.
- •Illiterate
- •No internet access
- •Taking part in another current research project focused on mental health.
结局指标
主要结局
Estimation of effect size for changes in depression.
时间窗: Measured at 12 months post study start date.
Obtain an estimate of effect size for changes in depression, from pre to post intervention. Change in effect size for depression will be measured using Standardised Mean Difference (SMD) of scores on Patient Health Questionnaire-9 (PHQ-9) from pre to post intervention.
Evaluation of recruitment and retention.
时间窗: Measured at 12 months post study start date
Evaluate how many women are recruited to the study, how many women complete the online modules and how many women give feedback on their experience via an online questionnaire.
Evaluation of feedback questionnaire data.
时间窗: Measured at 12 months post study start date
Evaluate the qualitative feedback women give regarding their experience of the intervention using an online questionnaire.
Estimate of Effect Size for changes in depression (2)
时间窗: Measured at 12 months post study start date.
Obtain an estimate of effect size for changes in depression, from pre to post intervention. Change in effect size for depression will be measured using Standardised Mean Difference (SMD) of scores on the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) from pre to post intervention.
Estimate of effect size for changes in depression (3)
时间窗: Measured at 12 months post study start date.
Obtain an estimate of effect size for changes in depression, from pre to post intervention. Change in effect size for depression will be measured using Standardised Mean Difference (SMD) of scores on the Edinburgh Postnatal Depression Score (EPDS) from pre to post intervention.
Estimation of effect size for changes in anxiety.
时间窗: Measured at 12 months post study start date.
Effect size for Anxiety will be measured using SMD for Generalised Anxiety-7 questionnaire scores before and after intervention.
Estimation of effect size for changes in social function.
时间窗: Measured at 12 months post study start date.
Effect size for social function will be measured using SMD for score on pregnancy experience scale (PES) pre and post intervention.
Estimation of effect size for changes in attachment.
时间窗: Measured at 12 months post study start date.
Effect size in attachment will be measured using SMD for scores on Prenatal Attachment Inventory both before and after intervention.
次要结局
- Measure mother-baby relationship (Antenatal)(Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), and Post Enjoy Your Bump Intervention (before 38 weeks gestation))
- Measure mother-baby relationship (Postnatal)(Score recorded at 12 weeks postnatal)
- Time taken to complete intervention (1)(Data will be recorded at participant completion of Enjoy Your Bump intervention. Participants are required to complete intervention before they are 38+0 weeks pregnant.)
- Depression score (1)(Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation) and 12 weeks Postnatal.)
- Depression score (2)(Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation) and 12 weeks Postnatal.)
- Depression score (3)(Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation) and 12 weeks Postnatal.)
- Anxiety score(Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation) and 12 weeks Postnatal.)
- Time taken to complete intervention (2).(Data will be recorded at participant completion of Enjoy Your Bump intervention. Participants are required to complete intervention before they are 38+0 weeks pregnant.)
- Delivery and support of intervention(Data will be recorded at participant completion of Enjoy Your Bump intervention. Participants are required to complete intervention before they are 38+0 weeks pregnant.)
- Pregnancy Experience(Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation))