Fear of Childbirth - Comparison of Two Treatments

NCT02306434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2018-04-13

No results posted yet for this study

Summary

Childbirth related fear is a public health issue strongly related to subsequent reproduction, a request for caesarean section and women's and children's health. Currently, women are offered 3-5 counseling sessions with specially trained midwives and obstetricians in most Swedish hospitals as standard care (SC). In general, women are satisfied with counseling but research show no major effect on cesarean section rates neither in decreased level of childbirth related fear. It is therefore important to find the best available treatment for this issue.

The aim of this program is to compare Internet given cognitive behavior therapy (ICBT) with standard counseling care for pregnant women reporting childbirth related fear.

Research questions: What effect does ICBT compared to SC have on a) the level of childbirth related fear b) a request for cesarean section c) compliance and satisfaction with treatment.

Design: A randomized controlled trial of women reporting childbirth related fear during pregnancy. One arm will receive SC and one arm ICBT though the U-CARE platform. Follow up of given treatment will occur at 30 and 36 weeks of pregnancy, two months and one year after birth. Intervention: The intervention will focus on management of childbirth related fear. This means that the participants do weekly sessions and homework assignments during pregnancy.

Primary outcome will be level of childbirth related fear measured at 36 weeks of pregnancy.

Secondary outcomes are level of childbirth related fear at 2 months and one year after birth, preferences for mode of birth, request for elective cesarean section, compliance and satisfaction with treatment and costs.

Expected benefits: This study will contribute to the development of new treatment methods for childbirth related fear. Evidence of the best treatment to reduce childbirth related fear based on the results from this study could be implemented in clinical practice and hopefully decreases the numbers of cesarean sections without medical indications.

Conditions

  • Fear of Childbirth
  • Pregnancy

Interventions

BEHAVIORAL

Therapy by iCBT

Internet Cognitive behavioral therapy (iCBT) is given by a psychologist in the U-CARE platform. The intervention will focus on management of childbirth related fear. This means that the participants read texts and do homework assignments instructed from an internet page. Additional resources such as pictures, animations, videos and sounds will be a part of the treatment program. A psychologist will communicate with the participants through internal text-messages and will give feed back on their home work assignments. The content of the intervention will be standard components from CBT, for example relaxation training, behavioral activation, exposure for fear related stimuli, cognitive restructuring, behavioral sleep treatment.

OTHER

Standard care-counselling

Standard care (Counselling by midwives)

Sponsors & Collaborators

  • Mid Sweden University

    collaborator OTHER
  • University of Melbourne

    collaborator OTHER
  • Uppsala University

    lead OTHER

Principal Investigators

  • Christine Rubertsson, Ass Prof · Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02306434 on ClinicalTrials.gov