Tocophobia(Victoria)NCT02266186
Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy
A study testing Traditional Cognitive behavioural therapy and Internet based Cognitive behavioural therapy in people with Tocophobia, run by Linkoeping University at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Tocophobia
- What is being tested?
- Traditional Cognitive behavioural therapy and Internet based Cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2013to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Suicidal, psychotic or schizophrenic symptoms.
- Not motivated to work with their fear.
- Ongoing psychological therapy because of fear of childbirth
- Non Swedish- speaking women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy (Victoria)
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.
Read the detailed description
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
- Conditions
- Tocophobia
- Being tested
- Traditional Cognitive behavioural therapy, Internet based Cognitive behavioural therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Cognitive behavioural therapyBehavioural
Also called Traditional CBT .
Therapist supported live therapy
Internet based Cognitive behavioural therapyBehavioural
Also called Internet CBT
Internetbased CBTwith limited therapist support
| Study group | Role | What they receive |
|---|---|---|
| Internet CBT | Experimental | Intervention:Internet-based cognitive behavioural therapy. Receives: Behavioral: Internet based Cognitive behavioural therapy |
| Traditional CBT | Active comparator | Intervention:Traditional CBT given by a therapist following given modules. Receives: Behavioral: Traditional Cognitive behavioural therapy |
| Care as usual | No intervention | Childbirth preparation according to local routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of fear of childbirth
self rating with: Wijma Expectancy/Experience Questionnaire version A (W-DEQ vers. A)
Measured: Change baseline to after 8 weeks of treatment
Secondary outcomes (2)
Level of trauma
self rating with: Traumatic Event Scale (TES)
Measured: Change from baseline to 3 months after delivery
Level of anxiety and depression
self rating with: Hospital anxiety and depression scale (HADS)
Measured: Change from baseline to 3 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TocophobiaStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Klaas Wijma, Linkoeping University
- Investigators
- Klaas WIjma, Professor, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266186
- Sponsor's protocol ID
- Dnr2012/375-31
- Acronym
- (Victoria)
- Status last verified
- Mar 2018
- First submitted
- 22 Sep 2014
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Severe Fear of Childbirth With CBT, Comparison of ICBT With Traditional Live Therapy (Victoria)
- ClinicalTrials.gov ID
- NCT02266186
- Acronym / sponsor ID
- (Victoria) / Dnr2012/375-31
- Conditions
- Tocophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Oct 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet CBT | Experimental | Behavioral: Internet based Cognitive behavioural therapyIntervention:Internet-based cognitive behavioural therapy. |
| Traditional CBT | Active comparator | Behavioral: Traditional Cognitive behavioural therapyIntervention:Traditional CBT given by a therapist following given modules. |
| Care as usual | No intervention | –Childbirth preparation according to local routine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Suicidal, psychotic or schizophrenic symptoms.
- Not motivated to work with their fear.
- Ongoing psychological therapy because of fear of childbirth
- Non Swedish- speaking women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Cognitive behavioural therapyAlso: Traditional CBT .Therapist supported live therapy | Behavioural | Traditional CBT |
| Internet based Cognitive behavioural therapyAlso: Internet CBTInternetbased CBTwith limited therapist support | Behavioural | Internet CBT |
Primary outcome
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)
2 secondary outcomes
Level of trauma
Time frame: Change from baseline to 3 months after delivery
Level of anxiety and depression
Time frame: Change from baseline to 3 months after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- HomepageLink provided by the sponsor.
Related trials for Tocophobia
Not yet recruiting
Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth
Fear of Childbirth, Mandala Coloring
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
Mindfulness Psychoeducation Based on Transtheoretical Model for Fear of Childbirth
Fear of Childbirth, Pregnancy
Recruiting
Virtual Reality-Enabled Digital Storytelling
Primiparous Pregnant Women
Not yet recruiting
Effectiveness of Gestaverso Virtual Reality Birth Preparation in Women With Previous Negative Birth Experiences
Fear of Childbirth, Childbirth-Related Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaas WIjma, Professor study director
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Cognitive behavioural therapy and Internet based Cognitive behavioural therapy in people with Tocophobia, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of fear of childbirth (time frame: Change baseline to after 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.