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

NCT ID: NCT02266186

Last Updated: 2018-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Tocophobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internet CBT

Intervention:Internet-based cognitive behavioural therapy.

Group Type EXPERIMENTAL

Internet based Cognitive behavioural therapy

Intervention Type BEHAVIORAL

Internetbased CBTwith limited therapist support

Traditional CBT

Intervention:Traditional CBT given by a therapist following given modules.

Group Type ACTIVE_COMPARATOR

Traditional Cognitive behavioural therapy

Intervention Type BEHAVIORAL

Therapist supported live therapy

Care as usual

Childbirth preparation according to local routine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Traditional Cognitive behavioural therapy

Therapist supported live therapy

Intervention Type BEHAVIORAL

Internet based Cognitive behavioural therapy

Internetbased CBTwith limited therapist support

Intervention Type BEHAVIORAL

Other Intervention Names

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Traditional CBT . Internet CBT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Klaas Wijma

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaas WIjma, Professor

Role: STUDY_DIRECTOR

Linkoeping University

Locations

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Kvinnokliniken, Vrinnevisjukhuset

Norrköping, , Sweden

Site Status

Countries

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Sweden

Related Links

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Other Identifiers

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Dnr2012/375-31

Identifier Type: -

Identifier Source: org_study_id

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