Public Health Nurse-Delivered 1-Day Cognitive Behavioural Therapy-Based Workshops for Postpartum Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 1
- 主要终点
- Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
Public Health Nurses (PHN) received training to deliver a day-long Cognitive Behavioural Therapy (CBT)-based workshop for treating postpartum depression (PPD). Participants in the study are randomly assigned to the treatment group (1-day CBT workshop) or control group (usual postnatal care). Data will be collected from all participants at baseline, 3 and 6 months later.
The study will aim to determine if online day-long CBT-based workshops delivered by public health nurses can be added to treatment as usual to improve postpartum depression more than treatment as usual alone, iif the workshops are cost-effective, and if the workshops can stably improve depression, its common comorbidities and reduce adverse effects on the family.
Hypotheses: Online 1-Day CBT-Based Workshops delivered by PHNs will be an effective (and cost-effective) way to stably improve PPD, its comorbidities, and reduce its adverse effects on the family.
详细描述
Postpartum depression (PPD) is one of the most common complications of childbirth, affecting 1 in 5 mothers. Left untreated, it increases the risk of future depressive episodes and can have profound effects on offspring. A single case of PPD has been estimated to cost as much as $150,000 over the lifespan, or $3 billion for each annual cohort of Canadian births.
Current clinical practice guidelines recommend evidence-based psychotherapies (e.g., cognitive behavioural therapy (CBT)) as 1st-line treatments for the vast majority of mothers with PPD. The key role that psychotherapy plays in the treatment of PPD is further emphasized by the US Preventive Services Task Force which recommends universal PPD screening, but only when CBT or other evidence-based counseling is available.
While treating PPD can reduce its adverse effects, safe, timely, accessible interventions are essential to optimizing outcomes. However, only treatments that can be upscaled can have an impact on PPD at the population level.
The delivery of psychotherapy in large groups (up to 30 participants) is a relatively new phenomenon, but may be capable of addressing mothers needs, as well as treating PPD on the scale required to address its prevalence. Brief (i.e., 1-Day) interventions contain the core content of more comprehensive, evidence-based interventions, but their brevity makes them easier to disseminate beyond traditional treatment settings (e.g., in public health). 1-Day CBT-Based Workshops have been delivered by trained mental health professionals (psychologists, psychiatrists) to treat generalized anxiety disorder and depression in general population samples, and postpartum depression.
Research Questions:
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
Participants and the research coordinator cannot be blinded to group condition though the research assistants making reminder calls and data analysts will not be aware of group status.
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
- •18 years or older
- •have infant <12 months at time of recruitment
- •fluent in written/spoken English
排除标准
- •current bipolar, psychotic and/or substance use disorders
研究组 & 干预措施
Online 1-Day CBT-Based Workshop
Participants assigned to the treatment arm will attend a day long CBT-based workshop delivered online by two trained public health nurses in addition to receiving usual care.
干预措施: 1-Day Cognitive Behavioural Therapy-Based Workshop (Behavioral)
Treatment as Usual
Participants assigned to the control arm will continue to receive standard postnatal care from their healthcare providers.
结局指标
主要结局
Edinburgh Postnatal Depression Scale (EPDS)
时间窗: 12 weeks
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item gold standard measure of PPD. Total scores range from 0-30 with higher scores indicating worse depressive symptoms. A score ≥13 is consistent with PPD and changes in scores \>4 are accepted as being indicative of clinically significant change.
次要结局
- Edinburgh Postnatal Depression Scale (EPDS)(6 months)
- EQ-5D-5L(12 weeks and 6 months)
- Mini International Neuropsychiatric Interview - Generalized Anxiety Disorder Module(12 weeks and 6 months)
- Generalized Anxiety Disorder 7-Item Scale(12 weeks and 6 months)
- Multidimensional Scale of Perceived Social Support (MSPSS)(12 weeks and 6 months)
- Parenting Stress Index (PSI-SF)(12 weeks and 6 months)
- Healthcare Resource Utilization Questionnaire(12 weeks and 6 months)
- Mini International Neuropsychiatric Interview - Major Depressive Disorder Module(12 weeks and 6 months)
- Postpartum Bonding Questionnaire (PBQ(12 weeks and 6 months)
- Infant Behavior Questionnaire-Revised Very Short Form (IBQ-R)(12 weeks and 6 months)