- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02266186
Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy ((Victoria))
Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy (Victoria)
Study Overview
Status
Conditions
Detailed 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.
- 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Norrköping, Sweden, 60379
- Kvinnokliniken, Vrinnevisjukhuset
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Internet CBT
Intervention:Internet-based cognitive behavioural therapy.
|
Internetbased CBTwith limited therapist support
Other Names:
|
Active Comparator: Traditional CBT
Intervention:Traditional CBT given by a therapist following given modules.
|
Therapist supported live therapy
Other Names:
|
No Intervention: Care as usual
Childbirth preparation according to local routine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of fear of childbirth
Time Frame: Change baseline to after 8 weeks of treatment
|
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
Time Frame: Change from baseline to 3 months after delivery
|
self rating with: Traumatic Event Scale (TES)
|
Change from baseline to 3 months after delivery
|
Level of anxiety and depression
Time Frame: Change from baseline to 3 months after delivery
|
self rating with: Hospital anxiety and depression scale (HADS)
|
Change from baseline to 3 months after delivery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of women delivered vaginally
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 |
3 months after delivery
|
Appointments
Time Frame: 3 months after delivery
|
Appointments during pregnancy at Obstetrical department
|
3 months after delivery
|
Sick leave
Time Frame: 3 months after delivery
|
Number of women at Sick leave during pregnancy
|
3 months after delivery
|
Mother-child interaction postpartum
Time Frame: 3 months after delivery
|
Self-estimated with MAMA
|
3 months after delivery
|
Self-estimated quality of life
Time Frame: 3 moths after delivery
|
Self-estimated with EQ5D
|
3 moths after delivery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Klaas WIjma, Professor, Linkoeping University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Dnr2012/375-31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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