Main objectieve of this study is if EMDR is an effective treatment for women with FoC. Our hypotheses are that in follow-up measurement compared to the pretreatment-measurement 1) WITHIN the treatment group there will be a decrease in the severity…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measurement is severity of FoC-symptoms
Secondary outcome
Secundary outcome measurements are the amount of caesarean sections, Healthcare
costs, subjective delivery experience, and the percentage of obstetrical
complications.
Background summary
In 7.5% of pregnant women, there is a pathological fear of childbirth: Fear of
Childbirth ( FoC ). In these women, the fear of childbirth can lead to
terminating pregnancy, avoiding pregnancy, or demanding a primary caesarean
section. FoC is associated with a higher risk of premature birth or emergency
caesarean section, a six times higher chance of getting a post-traumatic stress
disorder after childbirth and possibly a longer duration of labor .
Some studies show a positive effect of individual psychotherapy,
psycho-education and group learning relaxation techniques. For specific phobias
in general, cognitive behavioral therapy with exposure (in vivo) is the
treatment of choice. Research shows that Eye Movement Desensitization and
Reprocessing (EMDR) is also effective for specific phobias. We expect EMDR may
also be effective for FoC. Thereby, in some phobias, including FoC, it can be
very difficult to apply exposure in vivo.
Study objective
Main objectieve of this study is if EMDR is an effective treatment for women
with FoC. Our hypotheses are that in follow-up measurement compared to the
pretreatment-measurement 1) WITHIN the treatment group there will be a decrease
in the severity of the FoC symptoms, and 2) BETWEEN the treatment group and
care-as-usual group there will be less severe FoC symptoms, less caesarean
sections, lower health care costs, and a more positive birth experience. Last
hypothesis is 3) that following EMDR does not lead to more obstetric
complications, especially preterm birth. Since we provide results regarding
both efficacy and safety, our main objective thus can be answered.
Study design
The procedure of this randomized controlled trial (RCT) is as follows. At a
gestational age of approximately 8-20 weeks screening takes place among all
pregnant women. When their sum score on the WDEQ-A * 85, FoC is diagnosed and
they are invited to a clinical interview. Afterwards, they are randomized
between two groups:
- the treatment group. These women will be offered EMDR (up to 3 sessions) in
addition to standard antenatal care during pregnancy
- the control group. These women receive the standard antenatal care.
In both groups, 60 participants will be allocated. There will be a maximum of
six treatment sessions, after which the post-treatment antepartum measurement
will be conducted (T1). 2-3 months postpartum the post treatment postpartum
measurement will be conducted(T2). The outcome assessors of T1 and T2 are
blinded to participants group assignment.
Study burden and risks
Participants are asked at least once to complete a short screening
questionnaire during (one of their) first visits to a midwife of gynaecologist.
For the majority of the women (those who scored below cut-off) this will be the
only effort: no treatment or other measurements will follow. The screening
questionnaire includes questions about psychological well-being, and fits into
the context of the visit to the midwife/gynaecologist where already an
anamnesis is conducted.
If scored above cut-off, two clinical interviews will follow, a weekly/after
each session written questionnaire. After childbirth there will be one last
written questionnaire.
Aborting the questionnaire, or deciding not to hand in is possible. Data are
anonymised. There are no known risks of EMDR treatment during pregnancy.
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Oosterpark 9
Amsterdam 1091 A.C.
NL
Oosterpark 9
Amsterdam 1091 A.C.
NL
Listed location countries
Age
Inclusion criteria
Pregnant women with a gestational age of circa 8-20 weeks, who mastered the Dutch language
Exclusion criteria
<18 years old
Current psychological treatment
Intermediate or high suicide risk (based upon MINI interview)
Severe psychotic disorder, such as schizophrenia or current psychosis (based upon MINI-interview)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL49305.100.14 |
OMON | NL-OMON23809 |