Kvinnokliniken, Vrinnevisjukhuset
Norrköping, 60379, Sweden
NCT Number: NCT02266186
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.
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Notify Me18 year–50 year
Female
Interventional
Not applicable
Norrköping, 60379, Sweden
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.
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Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Therapist supported live therapy
Other names: Traditional CBT .
Internetbased CBTwith limited therapist support
Other names: Internet CBT
Time frame: Change baseline to after 8 weeks of treatment
self rating with: Wijma Expectancy/Experience Questionnaire version A (W-DEQ vers. A)
Time frame: Change from baseline to 3 months after delivery
self rating with: Traumatic Event Scale (TES)
Time frame: Change from baseline to 3 months after delivery
self rating with: Hospital anxiety and depression scale (HADS)
Time frame: 3 months after delivery
Number of women delivered vaginally
Influence of fear of childbirth on mother-child interaction ( self rating with MAMA) Self estimated quality of life EQ5D
Time frame: 3 months after delivery
Appointments during pregnancy at Obstetrical department
Time frame: 3 months after delivery
Number of women at Sick leave during pregnancy
Time frame: 3 months after delivery
Self-estimated with MAMA
Time frame: 3 moths after delivery
Self-estimated with EQ5D
Linkoeping University
Other Gov
Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy (Victoria)
Acronym: (Victoria)
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