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Completed

NCT Number: NCT02266186

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kvinnokliniken, Vrinnevisjukhuset

Norrköping, 60379, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional Cognitive behavioural therapy

Behavioral

Therapist supported live therapy

Other names: Traditional CBT .

Internet based Cognitive Behavioural Therapy

Behavioral

Internetbased CBTwith limited therapist support

Other names: Internet CBT

Primary outcomes

  1. 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)

Secondary outcomes

  1. Level of trauma

    Time frame: Change from baseline to 3 months after delivery

    self rating with: Traumatic Event Scale (TES)

  2. Level of anxiety and depression

    Time frame: Change from baseline to 3 months after delivery

    self rating with: Hospital anxiety and depression scale (HADS)

Other outcomes

  1. 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

  2. Appointments

    Time frame: 3 months after delivery

    Appointments during pregnancy at Obstetrical department

  3. Sick leave

    Time frame: 3 months after delivery

    Number of women at Sick leave during pregnancy

  4. Mother-child interaction postpartum

    Time frame: 3 months after delivery

    Self-estimated with MAMA

  5. Self-estimated quality of life

    Time frame: 3 moths after delivery

    Self-estimated with EQ5D

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Acronym: (Victoria)

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Oct 16, 2014
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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