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临床试验/NCT02266186
NCT02266186已完成不适用

Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy (Victoria)

Linkoeping University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年10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
发起方
入组人数
60
试验地点
2
主要终点
Level of fear of childbirth

研究概览

简要总结

The purpose of this project To study the efficacy of Internet-based guided self-help program of Cognitive Behaviour Therapy (ICBT) compared to traditional individual live CBT in a group of women with severe fear of childbirth (S-FOC). The treatment groups are compared with a control group receiving individual support at their antenatal clinics.

详细描述

In Sweden, every year, about 6000 pregnant women suffer from severe FOC with consequences for the women's psychological health before, during and after birth, the way they manage the childbirth, and for their postpartum mother-child interaction.

In this project we want to examine the effect of CBT on SFOC given in two different ways. We compare these results with a group receiving support given traditionally on the clinics. But also a group without S-FOC. In case there is a significant effect of CBT, that is comparable given live as well as ICBT, we should have developed an adequate way of treatment that could be implemented in ordinary health care.

Hypothesis: S-FOC decreases in same extent (30 units on the W-DEQ) in both of the treatment groups. The group with S-FOC,that gets treatment as usual is consuming more healthcare than the groups receiving therapy.

One hundred and twenty pregnant women with severe fear of childbirth (S-FOC) according to their sum score on the Wijma Expectancy/Experience Questionnaire (W-DEQ vers. A) ≥85, and 40 women without S-FOC (W-DEQ <85) are recruited at 7 participating clinics in Sweden. In a first baseline measuring phase 40 women with S-FOC and 40 women without S-FOC are followed as control groups, receiving, if necessary, treatment according to the local routine. In the intervention part of the study 80 women with S-FOC are randomized either into ICBT or live CBT.

  1. ICBT is as effective as traditional live therapy.
  2. ICBT is as efficient as traditional live therapy

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women in 16-30weeks of pregnancy at time for enrolment
  • Able to read and write Swedish language
  • having the possibility to use the internet during the therapy.

排除标准

  • Suicidal, psychotic or schizophrenic symptoms.
  • Not motivated to work with their fear.
  • Ongoing psychological therapy because of fear of childbirth
  • Non Swedish- speaking women

研究组 & 干预措施

Internet CBT

Experimental

Intervention:Internet-based cognitive behavioural therapy.

干预措施: Internet based Cognitive behavioural therapy (Behavioral)

Traditional CBT

Active Comparator

Intervention:Traditional CBT given by a therapist following given modules.

干预措施: Traditional Cognitive behavioural therapy (Behavioral)

Care as usual

No Intervention

Childbirth preparation according to local routine

结局指标

主要结局

Level of fear of childbirth

时间窗: Change baseline to after 8 weeks of treatment

self rating with: Wijma Expectancy/Experience Questionnaire version A (W-DEQ vers. A)

次要结局

  • Level of trauma(Change from baseline to 3 months after delivery)
  • Level of anxiety and depression(Change from baseline to 3 months after delivery)

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Klaas Wijma

Professor

Linkoeping University

研究点 (2)

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