Clinical trial NCT02266186: Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy
Official title: Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy (Victoria)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tocophobia
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2014-10-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Level of fear of childbirth
timeFrame: Change baseline to after 8 weeks of treatment
Secondary outcomes:
measure: Level of trauma
timeFrame: Change from baseline to 3 months after delivery
measure: Level of anxiety and depression
timeFrame: Change from baseline to 3 months after delivery
Other outcomes:
measure: Number of women delivered vaginally
timeFrame: 3 months after delivery
measure: Appointments
timeFrame: 3 months after delivery
measure: Sick leave
timeFrame: 3 months after delivery
measure: Mother-child interaction postpartum
timeFrame: 3 months after delivery
measure: Self-estimated quality of life
timeFrame: 3 moths after delivery
Locations:
city: Norrköping
country: Sweden
facility: Kvinnokliniken, Vrinnevisjukhuset
Study officials:
affiliation: Linkoeping University
name: Klaas WIjma, Professor
role: STUDY_DIRECTOR
References: