NCT02306434

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

December 1, 2014

Last Update Submit

April 11, 2018

Conditions

Fear of ChildbirthPregnancy

Keywords

childbirth fearInternet CBTcounsellingantenatal carepostnatal carechildbirthCognitive behavioural therapy

Outcome Measures

Primary Outcomes (1)

  • Level of childbirth related fear (FOBS)

    Level of childbirth related fear

    36 weeks of gestation

Secondary Outcomes (4)

  • Level of childbirth related fear (FOBS)

    2 months post-partum

  • Level of childbirth related fear (FOBS)

    1 year post-partum

  • Preferred mode of birth (vaginal or cesarean section)

    36 weeks of gestation

  • Request for cesarean section (yes or no)

    1 year postpartum

Other Outcomes (3)

  • Compliance with treatment (Number of treatments and satisfaction)

    2 month postpartum

  • Compliance with treatment (Number of treatments and satisfaction)

    1 year postpartum

  • Costs (SEK (Swedish currency)

    1 year postpartum

Study Arms (2)

Therapy by iCBT

ACTIVE COMPARATOR

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.

Behavioral: Therapy by iCBT

Standard care-Counselling

OTHER

Counselling for childbirth fear is given by the antenatal care midwife and by specially trained midwives working in collaboration with obstetricians at approximately 3-5 face to face counselling sessions. Often a visit to the delivery unit is included in the program and a care plan for the coming birth.

Other: Standard care-counselling

Interventions

Therapy by iCBTBEHAVIORAL

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.

Also known as: Internet based Cognitive behavioural therapy
Therapy by iCBT
Standard care-counsellingOTHER

Standard care (Counselling by midwives)

Standard care-Counselling

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mastery of the Swedish language,
  • FOBS above 60,
  • internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala university

Uppsala, 75185, Sweden

Location

Related Publications (2)

  • O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.

    PMID: 34231203DERIVED

  • Rondung E, Ternstrom E, Hildingsson I, Haines HM, Sundin O, Ekdahl J, Karlstrom A, Larsson B, Segeblad B, Baylis R, Rubertsson C. Comparing Internet-Based Cognitive Behavioral Therapy With Standard Care for Women With Fear of Birth: Randomized Controlled Trial. JMIR Ment Health. 2018 Aug 10;5(3):e10420. doi: 10.2196/10420.

    PMID: 30097422DERIVED

Related Links

Study Officials

  • Christine Rubertsson, Ass Prof

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 13, 2018

Record last verified: 2018-04

Locations

SE(1)