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

March 7, 2018 updated by: Klaas Wijma, Linkoeping University

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

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.

Study Overview

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Norrköping, Sweden, 60379
        • Kvinnokliniken, Vrinnevisjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Internet CBT
Active Comparator: Traditional CBT
Intervention:Traditional CBT given by a therapist following given modules.
Therapist supported live therapy
Other Names:
  • Traditional CBT .
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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Klaas WIjma, Professor, Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

October 13, 2014

First Posted (Estimate)

October 16, 2014

Study Record Updates

Last Update Posted (Actual)

March 8, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

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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