The main objective of this study is whether EMDR is an appropriate treatment for women with PTSD after a previous birth. The resulting hypotheses are that at the two follow-up meaurements, in relation to the pretreatment-measurement 1) WITHIN theā¦
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 the amount of PTSD symptoms.
Secondary outcome
Secundary outcome measurements are the percentage of PTSD diagnoses (at T1 and
T2), the percentage of caesarean sections, Healthcare costs, subjective
delivery experience, and the percentage of obstetrical complications.
Background summary
After childbirth, 1-3% of the mothers will develop a posttraumatic stress
disorder (PTSD). Many women will become pregnant again, and experience severe
anxiety associated with pregnancy and childbirth. Anxiety during pregnancy is
associated with adverse obstetric and neonatal outcomes. PTSD is related with
an increased risk of ectopic pregnancy, sontaneous abortion, hyperemesis
gravidarum, premature labor and excessive fetal growth. The avoidance in PTSD
can result in avoiding prenatal care, or insisting on having a primary
caesarean section.
In most of the (inter)national guidelines EMDR and CBT are the two recommended
treatments for PTSD. The best treatment for PTSD after childbirth is not yet
evidence-based. In two non-controlled studies with a few women, EMDR seems to
be a appropriate treatment.
Study objective
The main objective of this study is whether EMDR is an appropriate treatment
for women with PTSD after a previous birth. The resulting hypotheses are that
at the two follow-up meaurements, in relation to the pretreatment-measurement
1) WITHIN the treatment group there is a decline in the severity of
PTSD-symptoms and percentage of PTSD-diagnoses, and 2)BETWEEN treatment group
and care-as-usual group there is a decrease in severity of PTSD symptoms and a
lower percentage of PTSD diagnoses in the treatment group, fewer caesarean
sections, lower healthcare costs, and a more positive childbirth experience.
Last hypothesis is 3)EMDR does not lead to more obstetric complications,
especially preterm birth. Since we provide result regarding both efficacy and
safety, our main question thus can be answered
Study design
This study is a randomized controlled trial (RCT). At a gestational age of
approximately 8-20 weeks screening takes place among all pregnant women who
have given birth at least once before, after at least 16 weeks gestation. When
they score above the cut-off point on a PTSD-screening questionnaire (screening
wit PCL-5), the pregnant woman are referred to an independent assessor for a
clinical interview (CAPS and MINI plus. When PTSD after previous childbirth is
diagnosed, randomization takes place into 2 groups:
- The treatment group. These women will be offered EMDR (with a maximum of 3
sessions of 90 minutes) in addition to standard antenatal care during pregnancy.
- The control group. These women are the standard antenatal care
(care-as-usual).
In both groups, 25 participants will be allocated. There will be a maximum of 3
treatment sessions in the treatment group, 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 (on of their) first visits to a midwife or gynaecologist.
For the majority of the women (those who scored below the cut-off) this will be
the only effort: no treatment or other measurement 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 a anamnesis
is conducted.
If scored above cut-off, participants are asked for 2 clinical interviews, with
possible randomisation to maximum 3 EMDR sessions with a questionnaire or only
a questionnaire. After childbirth there will be one more 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.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
Multipara 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 | NL49304.100.14 |
OMON | NL-OMON20013 |