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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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

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

Conditions
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Tocophobia

Intervention / Treatment
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* Behavioral: Traditional Cognitive behavioural therapy
* Behavioral: Internet based Cognitive behavioural therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Suicidal, psychotic or schizophrenic symptoms. Not motivated to work with their fear. Ongoing psychological therapy because of fear of childbirth Non Swedish- speaking women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet CBT<br>Intervention:Internet-based cognitive behavioural therapy. | Behavioral: Internet based Cognitive behavioural therapy<br>* Internetbased CBTwith limited therapist support<br>* Other names: Internet CBT;|
| Active Comparator: Traditional CBT<br>Intervention:Traditional CBT given by a therapist following given modules. | Behavioral: Traditional Cognitive behavioural therapy<br>* Therapist supported live therapy<br>* Other names: Traditional CBT .;|
| No Intervention: Care as usual<br>Childbirth preparation according to local routine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | Change from baseline to 3 months after delivery |