Online Public Health Nurse-Delivered Group Cognitive Behavioural Therapy for Postpartum Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Maternal Depressive Symptoms
研究概览
简要总结
The primary objective of this study is to determine if online group CBT for PPD delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b) reducing relapse and recurrence, c) improving common comorbidities and complications of PPD including anxiety and the mother-infant relationship, and d) to determine if this treatment is cost-effective.
详细描述
A prospective, 1-site, parallel group, RCT (1:1 ratio) in which outcome assessors and data analysts will be blinded to maternal treatment will be used to compare online PHN-delivered group CBT for PPD to postnatal care as usual.
The primary objective of this study is to determine if online group CBT for PPD delivered by public health nurses is superior to postnatal care as usual in: a) acutely treating PPD, b) reducing relapse and recurrence, c) improving common comorbidities and complications of PPD including anxiety and the mother-infant relationship, and d) to determine if this treatment is cost-effective.
Women in the treatment group will participate in a 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The principal investigator, outcome assessors and data analysts will be blinded to participant allocation.
入排标准
- 年龄范围
- 18 Years 至 99 Years（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 of 10 or more and meet diagnostic criteria for current major depressive disorder on the Mini International Neuropsychiatric Interview-Plus (MINI-Plus). They will also all be within 12 months of delivering an infant.
排除标准
- •In order to increase the relevance and generalizability of our findings, 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. These are predictors of significant difficulty participating in therapy groups and/or non-response to CBT.
结局指标
主要结局
Maternal Depressive Symptoms
时间窗: 9 weeks
Edinburgh Postnatal Depression Scale (EPDS): The EPDS is the 10-item gold standard measure of maternal depressive symptoms. A score \>12 is consistent with PPD and changes in scores of 4 or more points are indicative of clinically significant improvement.
次要结局
- Anxiety(6 months)
- Mother-Infant Bonding(6 months)
- Relationship with Partner(9 weeks)
- Cost Effectiveness - costs(6 months)
- Cost Effectiveness - QALY(6 months)
- Infant Temperament(6 months)
- Maternal Major Depressive Disorder(9 weeks)
- Maternal Depressive Symptoms(6 months)
- Social Support(6 months)
研究者
Ryan Van Lieshout, MD, PhD
MD, PhD
McMaster University