Impact of Public Health Nurse Delivered Group CBT for Postpartum Depression on Women and Their Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
Postpartum depression (PPD) affects over 14,000 women in Ontario each year and can have profound effects on mothers, their children, and their families. The cost of one case of PPD exceeds $150,000, a significant proportion of which is related to its impact on offspring. However, difficulties accessing preferred treatments (e.g., psychotherapy) result in fewer than 15% of women receiving care. While Public Health Units have played an important role in PPD detection in Ontario, Public Health Nurses (PHNs) currently lack the skills to deliver evidence-based treatment to women. Cognitive Behavioural Therapy (CBT) delivered in group format is effective for treating depression in the perinatal period, and as PHNs are often the first point of contact for women experiencing PPD, with specialized training it is likely that they can deliver high-quality CBT.
The primary objective of this study is to determine if PHNs can be trained to deliver group Cognitive Behavioral Therapy (CBT) to acutely treat PPD, reduce relapse and recurrence, improve mother-infant attachment and parenting and optimize infant emotional functioning.
详细描述
In addition to its effects on maternal health, PPD can adversely affect mother-infant attachment, parenting, and the development and health of her children. The negative effects of PPD on offspring can include an increased risk of insecure attachment, poorer cognitive, language, and behavioral development, as well as an increased risk of emotion regulatory problems. To determine if PHNs can effectively deliver group CBT for PPD that is superior to postnatal care as usual, the investigators will proceed with a randomized controlled trial (RCT). Women in the treatment group will attend a 9-week group CBT intervention delivered by trained PHNs. Those in the control group will receive standard postnatal care.
This RCT will compare the effects of group CBT to postnatal care as usual on maternal depression, anxiety, mother-infant attachment, parenting, healthcare utilization and social support, as well as infant development, emotion regulation, and healthcare utilization
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligible women will be >18 years of age, understand and speak English (so that they can participate in the CBT group and complete study measures), have an EPDS score between 10 and
- •They will also all be within 12 months of delivering an infant
排除标准
- •Women can have psychiatric comorbidities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder.
结局指标
主要结局
Edinburgh Postnatal Depression Scale (EPDS)
时间窗: 6 months
The EPDS will be used to assess maternal depression. A score of \>12 is consistent with PPD and changes in scores \>4 are indicative of clinically significant improvement.
Mini International Neuropsychiatric Interview - Current Major Depressive Disorder
时间窗: 6 months
Used to assess maternal depression.
次要结局
- Ages and Stages Questionnaires - Third Edition(6 months)
- Salivary Cortisol(6 months)
- Corticolimbic Brain Function: EEG-Based Frontal Lobe Asymmetry (via MUSE Headband)(6 months)
- Social Provisions Scale(6 months)
- Penn State Worry Questionnaire (PSWQ)(6 months)
- Face-to-Face Still Face Paradigm(6 months)
- Parent-Child Early Relational Assessment(6 months)
- Maternal & Infant Healthcare Utilization(6 months)
- Infant Behaviour Questionnaire-Revised(6 months)
- Parasympathetic Nervous System Functioning: Heart Rate Variability(6 months)
- Postpartum Bonding Questionnaire(6 months)
研究者
Ryan Van Lieshout, MD, PhD
Assistant Professor, Department of Psychiatry and Behavioural Neurosciences
McMaster University