Online Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy (LTP+CaCBT) for Treating Depression in British Mothers of African and Caribbean Heritage: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in postnatal depression is being assessed
研究概览
简要总结
The pilot trial aims to test the feasibility, acceptability and cultural appropriateness of online LTP+CaCBT for treating postnatal depression and to improve the mental health and wellbeing of mothers and their children in the UK.
详细描述
Participants who scored 5 or above on Patient Health Questionnaire (PHQ-9) will be would be recruited and randomly assigned into one of two groups (experimental or controlled). Experimental groups will receive the online LTP+CaCBT treatment - the intervention will consist of a total of 12 group training sessions (approx. 60 minutes each). The controlled groups will receive 'placebo effects' in the form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions. Each of the two groups (both experimental and controlled) will be comprised of approximately 10 mother-child pairs per sub-group.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years and above
- •A mother with a child (0-3 years) from the African and/or Caribbean heritage
- •Able to provide full consent for their participation
- •A resident of the UK
- •Able to complete a baseline assessment
- •Score 5 or above on Patient Health Questionnaire (PHQ-9)
排除标准
- •Less than 18 years
- •Medical disorder that would prevent participation in a clinical trial such as Tuberculosis or heart failure
- •Temporary residents are unlikely to be available for follow up
- •Active suicidal ideation or any other severe mental disorder
- •Non-residents of the UK
- •Unable to consent
- •Patients currently undergoing severe mental health treatment
- •Unable to speak the English language fluently
- •Other significant physical or learning disability
结局指标
主要结局
Change in postnatal depression is being assessed
时间窗: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Primary outcome measure would be assessed using the Edinburgh Postnatal Depression Scale
Change in postnatal anxiety is being assessed
时间窗: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale
Change in health is being assessed
时间窗: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)
Change in social support is being assessed
时间窗: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Primary outcome measures would be assessed using the Oslo Social Support Scale
Change in health-related quality of life is being assessed
时间窗: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Outcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)
Change in service satisfaction is being assessed
时间窗: Change is being assessed at end of intervention, at 3-months and at 6-months post-intervention
Outcome measure would be assessed using the brief Verona Service Satisfaction Scale
Change in child physio-emotional development is being assessed
时间窗: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire
Change in parenting knowledge of child development is being assessed
时间窗: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Outcome measure would be assessed using the Learning through Play (LTP) Knowledge, Attitude and Practices (KAP) Questionnaire
次要结局
未报告次要终点
研究者
Dr Dung Jidong, PhD
Senior Lecturer
Nottingham Trent University