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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02266186
Acronym
(Victoria)
Enrollment
60
Registered
2014-10-16
Start date
2013-10-31
Completion date
2018-01-31
Last updated
2018-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tocophobia

Brief 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.

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. 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

Interventions

Therapist supported live therapy

Internetbased CBTwith limited therapist support

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Level of fear of childbirthChange baseline to after 8 weeks of treatmentself rating with: Wijma Expectancy/Experience Questionnaire version A (W-DEQ vers. A)

Secondary

MeasureTime frameDescription
Level of traumaChange from baseline to 3 months after deliveryself rating with: Traumatic Event Scale (TES)
Level of anxiety and depressionChange from baseline to 3 months after deliveryself rating with: Hospital anxiety and depression scale (HADS)

Other

MeasureTime frameDescription
Mother-child interaction postpartum3 months after deliverySelf-estimated with MAMA
Number of women delivered vaginally3 months after deliveryNumber of women delivered vaginally Influence of fear of childbirth on mother-child interaction ( self rating with MAMA) Self estimated quality of life EQ5D
Self-estimated quality of life3 moths after deliverySelf-estimated with EQ5D
Appointments3 months after deliveryAppointments during pregnancy at Obstetrical department
Sick leave3 months after deliveryNumber of women at Sick leave during pregnancy

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026