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临床试验/NCT04913584
NCT04913584已完成不适用

Online Peer-Delivered Group Cognitive Behavioural Therapy for Postpartum Depression: A Randomized Controlled Trial

McMaster University2 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2020年8月25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
183
试验地点
2
主要终点
Edinburgh Postnatal Depression Scale

研究概览

简要总结

Postpartum depression (PPD) affects up to one in five of women and has profound effects on mothers and their infants. Unfortunately, fewer than 15% of women with PPD receive evidence-based care. This is at least partly due to significant difficulties faced by women in accessing psychotherapies, their preferred treatment for PPD. Around the world, there is a significant lack of healthcare professionals trained to deliver CBT. This study will utilize a randomized controlled trial design (with wait-list controls) and recruit 174 participants to determine if women with a past history of PPD (i.e., lay peers) can be trained to deliver effective group CBT online to women currently struggling with PPD. If peers can be trained to provide effective CBT, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced.

详细描述

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

Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment and that screening only occur in settings where CBT is readily available. In order to increase access to treatment, screening efforts have been undertaken by public health units across Canada. This is despite recommendations that this only be conducted in the setting of timely access to evidence-based psychotherapies (e.g., CBT). The purpose of this study is to apply task shifting to the treatment of PPD by determining if women with a past history of PPD (i.e., lay peers) living in the community can be trained to deliver effective group CBT to women with current PPD.

A group CBT intervention for PPD has been developed and validated as well as a training program that pilot data suggests is capable of successfully training public health nurses with little background psychiatric training. This intervention is brief, effective, and generalizable to women with PPD in the community. Peer administered interventions (PAIs), those delivered by recovered former patients are increasingly recognized as potentially effective alternatives to traditional mental health care services. In addition, psychotherapy delivered online has been recognized as a delivery method that results in successful expression and interpretation of emotions, decreased inhibition and reluctance to disclose personal information and a strong therapeutic alliance between patients and providers. Online psychotherapy also has satisfaction ratings that are comparable to traditional in-person psychotherapy.

Eight lay peers will be trained to deliver our 9-week group CBT treatment. 174 women will be recruited and using a randomized controlled trial design (with wait-list controls), it will be determined if lay peers can deliver effective group CBT for PPD.

If peers can be trained to provide effective CBT online, 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
Single (Outcomes Assessor)

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 of age
  • Understand and speak English (so that they can participate in the CBT group and complete study measures)
  • Have an EPDS score >10
  • Be within 12 months of delivering an infant
  • Live within a 2-hour radius of the Brant Region.

排除标准

  • Bipolar disorder
  • Current psychotic disorder
  • Substance use disorder
  • Alcohol use disorder
  • Antisocial or borderline personality disorder

结局指标

主要结局

Edinburgh Postnatal Depression Scale

时间窗: 6 months

The EPDS will be used to assess maternal depression. A score of \>10 is consistent with probable PPD and changes in scores \>4 are indicative of clinically significant improvement.

次要结局

  • Adult Adolescent Parenting Inventory(6 months)
  • Mini International Neuropsychiatric Interview - Current Major Depressive Disorder(6 months)
  • Postpartum Bonding Questionnaire(6 months)
  • Canadian Community Health Survey Maternal Healthcare Utilization(6 months)
  • EuroQol-5D(6 months)
  • Social Provisions Scale(6 months)
  • Generalized Anxiety Disorder-7(6 months)
  • Parenting Stress Index (Short-Form)(6 months)
  • Ages and Stages Questionnaire(6 months)
  • Infant Behavior Questionnaire-Revised(6 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 (2)

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