Online Public Health Nurse Delivered 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshops for Postpartum Depression Symptoms: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Number of participants who complete the intervention (adherence)
研究概览
简要总结
Public Health Nurses received training to deliver a day-long Cognitive Behavioural Therapy-based workshop for treating postpartum depression. 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.
The study will aim to assess the feasibility of our methods and estimate the treatment effect of the primary outcome in preparation for a larger RCT. Objectives include:
- Recruit and randomize 96 participants within 5 months
- Questionnaire completion - 75% of participants complete all three questionnaires and structured interviews
- Retention - 75% of participants remain in study until completion
- 75% of participants in treatment group complete the intervention
- Estimate treatment effect and variance
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 (including those written by the NPA) 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.
The purpose of this pilot study is to determine the feasibility of our study procedures and estimate the treatment effect and variance of the primary outcome in preparation for a larger RCT to determine the effectiveness of a Public Health Nurse-Delivered 1-Day Cognitive Behavioural Therapy-Based Workshop for postpartum depression.
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
Treatment - 1 Day CBT-Based Workshop
Participants assigned to the treatment arm will attend a day long CBT-based workshop delivered by two trained public health nurses in addition to receiving usual care.
干预措施: 1-Day Cognitive Behavioural Therapy-Based Workshop (Behavioral)
Control - usual care
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
Number of participants who complete the intervention (adherence)
时间窗: 6 months
75% of participants who are enrolled in the treatment group will complete the 1-Day CBT-based workshop
Number of participants recruited in recruitment period
时间窗: 5 months
Recruit and randomize 96 participants within 5 months (48 treatment into four 1-day workshops (12 per workshop) and 48 control)
Number of participants who complete all data collection procedures
时间窗: 6 months
75% of participants complete all data collection procedures at all time points
Number of participants who complete study (retention)
时间窗: 6 months
75% of participants remain enrolled in the study until completion
次要结局
- Estimate Treatment effect - Edinburgh Postnatal Depression Scale (EPDS)(3 months)
研究者
Ryan Van Lieshout, MD, PhD
Associate Professor
McMaster University