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Clinical Trial Summary

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.


Clinical Trial Description

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

3. The effect will remain after the childbirth The successful therapy leads to

- less fear after childbirth

- less traumatic events during delivery

- less cesareans or instrumental deliveries

- less postpartum depressions

- less appointments in urgency during pregnancy

- better Mother-child relation at 3 months

- better self-estimated quality of life ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02266186
Study type Interventional
Source Linkoeping University
Contact
Status Completed
Phase N/A
Start date October 2013
Completion date January 2018

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