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临床试验/NCT04485000
NCT04485000已完成不适用

Online 1-Day CBT-Based Workshops for Postpartum Depression

McMaster University2 个研究点 分布在 1 个国家目标入组 403 人开始时间: 2020年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
403
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) already affects up to 1 in 5 women and left untreated costs $150,000 per case over the lifespan. Under normal conditions, just 10% of women with PPD get evidence-based treatment, a situation that has worsened substantially during COVID-19. The purpose of this study is to a assess if self-referred, online adaptation of a 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop for PPD delivered up to 30 women at a time can lead to reductions in PPD, if the workshops are cost-effective, and to assess workshop impact on common complications of PPD (anxiety, partner relationship discord, problems with mother-infant attachment). 388 women will be randomized to receive either immediate treatment or treatment 12 weeks later (waitlist control). Study measures will be collected at baseline (immediately before treatment workshop) and 12 weeks later (immediately before wait list control workshop).

详细描述

The COVID-19 pandemic has further exposed the vulnerabilities in social and economic systems that lead to inequalities for mothers with mental health problems and their children, worsening unintended systematic biases that exist within the healthcare system. These women have been among the most affected by the pandemic, experiencing substantial worry, isolation, loneliness, lack of control, and insomnia (1), all of which have increased PPD rates. They also have more responsibilities than ever before, providing care to their infants, toddlers, and older children, while managing their households and supporting their partners. They are also profoundly worried about job losses, reduced income, and food insecurity , all of which have disrupted family routines, increased partner conflict, and rates of intimate partner violence (2).

Postpartum depression (PPD) typically affects up to 1 in 5 women (3-5), increasing the risk of later depressive episodes (6), parenting problems (7), poor mother-infant attachment (8), and emotional, behavioural, and school problems in offspring (9,10). A single case of PPD has been estimated to cost as much as $150,000 over the lifespan (11), or $57 billion for each annual cohort of Canadian births. Even under ideal conditions, the healthcare system is poorly equipped to provide care for problems requiring urgent psychotherapy like PPD (e.g., just 1 in 10 women with PPD receive evidence-based care) (12). Barriers to care include women's preference for psychotherapy over medication, a lack of time, and a reluctance to travel to regular appointments (13,14). The healthcare system is now even less able to help these women as public health units that previously supported the mental health of mothers have shifted their priorities to direct COVID response. Moreover, social distancing recommendations aimed at reducing COVID-19 risk have inadvertently increased psychological distress and decreased access to resources that protect against PPD including social and practical support from family, friends, and professionals. The need for safe and accessible PPD treatment is further highlighted by the uptake of recent recommendations (written by the NPI) on managing PPD during COVID-19 which have been read 40,000 times since their posting (12).

Only interventions that are considered safe and that can be rapidly upscaled can have an impact on PPD at the population level during COVID-19 (15). Ideal large-scale interventions for PPD during COVID-19 are not only safe (i.e., delivered online), but are brief, utilize the treatments most preferred by women (i.e., non-pharmacological), easily accessible (i.e., self-referred), provide skills that can be used over the long-term, and delivered in large groups to increase social support. At present time, no interventions exist that meet all of these criteria.

The purpose of this study is to assess if Online 1-Day CBT-Based Workshops for PPD added to care as usual during the COVID-19 pandemic improve PPD more than usual care alone, if the workshops are cost-effective, and if these workshops reduce the impact of the common comorbidities and complications of PPD (anxiety, partner relationship discord, and poorer mother-infant attachment).

388 women who are 18 years or older, have a baby under 1 year old and have an Edinburgh Postnatal Depression Scale (EPDS) score of 10 or more will be randomized to receive either immediate treatment or treatment 12 weeks later (waitlist control) and changes in depression, anxiety, relationship quality, and mother-infant attachment will be compared.

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 (Care Provider, Outcomes Assessor)

盲法说明

Participants and the research coordinator cannot be blinded to group condition, but staff making reminders and data analysts will not be aware of group status. Therapists delivering groups will be randomly assigned to workshops and not notified 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

入选标准

  • 18 years or older
  • infant under 12 months old
  • EPDS score 10 or more
  • Fluent in written/spoken English

排除标准

  • 未提供

结局指标

主要结局

Edinburgh Postnatal Depression Scale (EPDS)

时间窗: Differences between experimental and control groups from T1 (baseline) to T2 (12 weeks) will be compared.

The gold standard measure of PPD in clinical practice/research. Produces a score of 0-30, with higher scores indicating more severe depressive symptoms. A change of 4 points is recognized as a clinically meaningful/significant improvement.

次要结局

  • Cost-effectiveness: Quality-Adjusted Life Year (QALY)(QALYs will be measured over the 12-week trial period.)
  • Cost-effectiveness: Costs of service(Resources consumed over the 12-week trial period from the perspective of public healthcare payer will be measured.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryan Van Lieshout, MD, PhD

MD, PhD

McMaster University

研究点 (2)

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