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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.
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.
ICBT is as effective as traditional live therapy.
ICBT is as efficient as traditional live therapy
.
The effect will remain after the childbirth The successful therapy leads to
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet CBT | Experimental | Intervention:Internet-based cognitive behavioural therapy. |
|
| Traditional CBT | Active Comparator | Intervention:Traditional CBT given by a therapist following given modules. |
|
| Care as usual | No Intervention | Childbirth preparation according to local routine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Cognitive behavioural therapy | Behavioral | Therapist supported live therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of fear of childbirth | self rating with: Wijma Expectancy/Experience Questionnaire version A (W-DEQ vers. A) | Change baseline to after 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Level of trauma | self rating with: Traumatic Event Scale (TES) | Change from baseline to 3 months after delivery |
| Level of anxiety and depression | self rating with: Hospital anxiety and depression scale (HADS) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of women delivered vaginally | Number of women delivered vaginally Influence of fear of childbirth on mother-child interaction ( self rating with MAMA) Self estimated quality of life EQ5D | 3 months after delivery |
| Appointments |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaas WIjma, Professor | Linkoeping University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kvinnokliniken, Vrinnevisjukhuset | Norrköping | 60379 | Sweden |
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| Internet based Cognitive behavioural therapy | Behavioral | Internetbased CBTwith limited therapist support |
|
|
| Change from baseline to 3 months after delivery |
Appointments during pregnancy at Obstetrical department
| 3 months after delivery |
| Sick leave | Number of women at Sick leave during pregnancy | 3 months after delivery |
| Mother-child interaction postpartum | Self-estimated with MAMA | 3 months after delivery |
| Self-estimated quality of life | Self-estimated with EQ5D | 3 moths after delivery |