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

Tocophobia Clinical Trial

— (Victoria)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266186
• Other study ID #: Dnr2012/375-31
• Status: Completed
• Phase: N/A
• First received: September 22, 2014
• Last updated: March 7, 2018
• Start date: October 2013
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Tocophobia

Intervention

Behavioral:
• Traditional Cognitive behavioural therapy
Therapist supported live therapy
• Internet based Cognitive behavioural therapy
Internetbased CBTwith limited therapist support

Locations

Country	Name	City	State
Sweden	Kvinnokliniken, Vrinnevisjukhuset	Norrköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Appointments	Appointments during pregnancy at Obstetrical department	3 months after delivery
Other	Sick leave	Number of women at Sick leave during pregnancy	3 months after delivery
Other	Mother-child interaction postpartum	Self-estimated with MAMA	3 months after delivery
Other	Self-estimated quality of life	Self-estimated with EQ5D	3 moths after delivery
Primary	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	Level of trauma	self rating with: Traumatic Event Scale (TES)	Change from baseline to 3 months after delivery
Secondary	Level of anxiety and depression	self rating with: Hospital anxiety and depression scale (HADS)	Change from baseline to 3 months after delivery

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