Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy
(Victoria)
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedMarch 8, 2018
March 1, 2018
4.2 years
September 22, 2014
March 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Level of trauma
Change from baseline to 3 months after delivery
Level of anxiety and depression
Change from baseline to 3 months after delivery
Other Outcomes (5)
Number of women delivered vaginally
3 months after delivery
Appointments
3 months after delivery
Sick leave
3 months after delivery
- +2 more other outcomes
Study Arms (3)
Internet CBT
EXPERIMENTALIntervention:Internet-based cognitive behavioural therapy.
Traditional CBT
ACTIVE COMPARATORIntervention:Traditional CBT given by a therapist following given modules.
Care as usual
NO INTERVENTIONChildbirth preparation according to local routine
Interventions
Therapist supported live therapy
Internetbased CBTwith limited therapist support
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Suicidal, psychotic or schizophrenic symptoms.
- Not motivated to work with their fear.
- Ongoing psychological therapy because of fear of childbirth
- Non Swedish- speaking women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kvinnokliniken, Vrinnevisjukhuset
Norrköping, 60379, Sweden
Related Links
Study Officials
- STUDY DIRECTOR
Klaas WIjma, Professor
Linkoeping University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 22, 2014
First Posted
October 16, 2014
Study Start
October 1, 2013
Primary Completion
December 1, 2017
Study Completion
January 1, 2018
Last Updated
March 8, 2018
Record last verified: 2018-03