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临床试验/NCT04183946
NCT04183946Unknown不适用

Willkommen Mutterglück: A Controlled Trial of Internet Based Cognitive Behavioural Therapy (CBT) for Pregnant and Postpartum Women With Depression and Anxiety

University of Zurich2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Change of depressive symptoms at four measuring points from baseline to follow up

研究概览

简要总结

This intervention study aims to evaluate the effectivity of web-based cognitive therapy in reducing depression and anxiety in pregnant and postpartum women. Moreover, it aims to assess treatment feasibility and usability of the treatment in the same population.

After an initial screening to determine the eligibility to participate, all participants fulfilling the inclusion criteria will receive their personal access login in order to start the intervention.

详细描述

Introduction: Evidence has shown that 10-20% of women suffer from depression during gestation and after birth (Barnes, 2014; Zaers, Waschke & Ehlert, 2008), while 7-21% present clinically relevant anxiety levels prenatally and following delivery (Grant, McMahon & Austin, 2008).

Previous research has shown that if a woman has high levels of depression or anxiety during pregnancy her child is at about double the risk for attention deficit hyperactivity disorder, conduct disorders, difficult temperament and behavioural problems later in development (O'Connor et al., 2002). High levels of prenatal anxiety and depression are frequently comorbid (Amiel Castro et al., 2016) and together with stress have been shown to increase risk for preterm delivery, low birth weight, impaired memory and cognitive function among others (Talge, Neal & Glover, 2007). The important biopsychological changes brought by the perinatal period (Ehlert et al., 1990) require constant attention from health workers since they carry relevant risk factors for the mother's health and for the infant's neurodevelopment (Schetter & Tanner, 2012).

Current depression interventions are not deliverable to a large number of individuals (Andersson & Titov, 2014). As seen worldwide, the difficulty to receive proper treatment for depression and anxiety is also evident in Switzerland. About half of people suffering from depression and/or anxiety are not diagnosed and consequently do not receive any sort of psychological or pharmaceutical treatment (Baer et al., 2013).

The internet offers an opportunity to deliver tailored interventions such as those based on cognitive behavioural therapy (CBT) to a large audience, cost-effectively, while preserving intervention fidelity and anonymity. The potential effectiveness of the internet is indicated by research demonstrating the successful delivery of CBT by computer and the use of the internet in the delivery of CBT treatment (Andrews et al., 2010). Recent reviews of the evidence have recommended further research that includes long-term follow-up and evaluation of novel treatment modalities such as the ones provided by internet (Dennis et al., 2012). Moreover, online interventions have been widely explored for different mental health problems (Sourander et al., 2016) suggesting its potential to increase access to and uptake of services for women with a perinatal disorder.

The "Willkommen Mutterglück" program is an 8-session, interactive web-based cognitive behavioural intervention for prenatal and postpartum depression and anxiety.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women or women who had given birth in the last year
  • between 18 and 45 years old
  • minor to moderate depression and/or generalised anxiety disorder
  • fluent in German
  • having a computer, laptop or handheld device with internet access

排除标准

  • women with a severe medical disorder or a severe psychological disorder such as psychosis, drug addiction and other substance abuse
  • women taking psychotropic medication
  • women with current suicidality
  • women who are currently receiving psychological treatment for depression or anxiety

结局指标

主要结局

Change of depressive symptoms at four measuring points from baseline to follow up

时间窗: At baseline, during week 4, 8, 16 of the intervention and at one month after completing intervention.

Measured with Beck's Depression Inventory (BDI)

Change of anxiety symptoms at four measuring points from baseline to follow up

时间窗: At baseline, during week 4, 8, 16 of the intervention and at one month after completing intervention.

Measured with Beck's Anxiety Inventory (BAI)

Change of depression symptoms from baseline until follow-up

时间窗: At baseline and during week 16 of the intervention

Measured with Edinburgh Postnatal Depression Scale (EPDS) Minimum score = 0, maximum score = 30. Cut off value is set at 12/13

Change of severity of depressive symptoms at four measuring points from baseline to follow up

时间窗: At baseline, during week 4, 8, 16 of the intervention and at one month after completing intervention.

Measured with Patient Health Questionnaire (PHQ) Ranges from 0-27 (0-4=none-minimal; 5-9=mild; 10-14=moderate; 15-19=moderately severe; 20-27=severe)

次要结局

  • Participant's satisfaction with the program and it's usability(At week 16 of the intervention)
  • Program's evaluation of feasibility with prenatal and postpartum women(From baseline until 1 month follow-up of the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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