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临床试验/NCT03285139
NCT03285139已完成不适用

Peer Administered Group Cognitive Behavioural Therapy for Postpartum Depression

McMaster University2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2018年1月3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
73
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 20% 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 cognitive behavioural therapy (CBT), a preferred 1st line treatment. In Ontario at present, there is a significant lack of personnel trained to deliver CBT. This study will utilize a randomized controlled trial design (with wait list controls) and recruit 70 participants to determine if women with a past history of PPD (i.e., lay peers) can be trained to deliver effective group CBT to women with current 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 province-wide. 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 community. Peer administered interventions (PAIs), those delivered by recovered former patients are increasingly recognized as potentially effective alternatives to traditional mental health care services. Eight lay peers will be trained to deliver our 9-week group CBT treatment. 74 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, 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

  • Eligible women will be >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 between 10 and
  • They will also all be within 12 months of delivering an infant.

排除标准

  • Women can have psychiatric commodities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or 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 \>12 is consistent with PPD and changes in scores \>4 are indicative of clinically significant improvement.

次要结局

  • Generalized Anxiety Disorder-7(6 months)
  • Postpartum Bonding Questionnaire(6 months)
  • Social Provisions Scale(6 months)
  • Adult Adolescent Parenting Inventory(6 months)
  • Therapist Evaluation Checklist(6 months)
  • EQ-5D(6 months)
  • CCHS Maternal Healthcare Utilization(6 months)
  • Cognitive Therapy Awareness Scale(6 months)
  • Mini International Neuropsychiatric Interview - Current Major Depressive Disorder(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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