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临床试验/NCT03654261
NCT03654261已完成不适用

1-Day Cognitive Behavioural Therapy Workshops for Postpartum Depression

McMaster University1 个研究点 分布在 1 个国家目标入组 461 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
461
试验地点
1
主要终点
Edinburgh Postnatal Depression Scale (EPDS)

研究概览

简要总结

Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families. Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy. A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each setting and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.

详细描述

Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families (1,2). Indeed, the cost of one case of PPD is estimated to exceed $150,000 (3). Unfortunately, fewer than 15% of women with PPD receive evidence-based care (4), which is at least partly due to difficulties accessing treatment, particularly therapies that are most preferred (e.g., psychotherapy (5)).

Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment (6). Moreover, consensus recommendations such as those made by the US Preventive Services Task Force suggest that screening only occur in settings where evidence-based counselling such as CBT is readily available (7). In order to increase access to treatment, screening efforts have been undertaken by public health units province-wide in Ontario. This has occurred despite the widespread availability of evidence-based psychotherapies.

A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each of 5 settings (Simcoe County, Kitchener-Waterloo Region, Halton Region, Prince Edward County, Elgin County), and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.

If this intervention is eventually proven effective, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced. Providing women with PPD with CBT skills at this crucial stage in life also has the capacity to prevent future depressive relapse with significant benefits for patients, families, employers, and the healthcare system.

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
None

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

  • infant <12 months
  • 18 years or older
  • EPDS score >10

排除标准

  • 未提供

研究组 & 干预措施

1-Day CBT Workshop - Immediate

Experimental

Women assigned to the immediate workshop group will participate in the first of two workshops (9 weeks apart).

干预措施: Cognitive Behavioural Therapy (Behavioral)

1-Day CBT Workshop - Waitlist

Experimental

Women assigned to the waitlist will participate in the second of two workshops (12 weeks apart).

干预措施: Cognitive Behavioural Therapy (Behavioral)

结局指标

主要结局

Edinburgh Postnatal Depression Scale (EPDS)

时间窗: 3 months

EPDS is the 10-item gold standard measure of PPD. A score \>10 is consistent with PPD and changes in scores \>4 are accepted as being indicative of clinically significant change

Beck Depression Inventory-II

时间窗: 3 months

The Beck Depression Inventory is a 21-item scale that assesses the emotional and cognitive symptoms of depression as the EPDS does, but additionally captures the somatic symptoms of depression. Higher scores on the BDI-II indicate more sever depression. The minimum score is 0 and maximum score is 63. Items are summed to generate a total score. 0-13 = minimal depression; 14-19 = mild depression; 20-28 = moderate depression; 29-63 = severe depression.

次要结局

  • Generalized Anxiety Disorder-7 (GAD-7)(3 months)
  • Postpartum Bonding Questionnaire(3 months)
  • Infant Behaviour Questionnaire-Revised (Very short form)(3 months)
  • Strengths and Difficulties Questionnaire(3 months)
  • EQ-5D(3 months)
  • Client Satisfaction Questionnaire(Immediately after workshop)
  • Healthcare Utilization(3 months)
  • Early Childhood Behaviour Questionnaire (very short form)(3 months)

研究者

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

Ryan Van Lieshout, MD, PhD

Assistant Professor, Department of Psychiatry and Behavioural Neurosciences

McMaster University

研究点 (1)

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