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Eye Movement Desensitization and Reprocessing treatment in pregnant women with Posttraumatic Stress Disorder after previous childbirth


- candidate number21888
- NTR NumberNTR5123
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-mrt-2015
- Secondary IDsNL4930410014 VCMO toetsingsnummer
- Public TitleEye Movement Desensitization and Reprocessing treatment in pregnant women with Posttraumatic Stress Disorder after previous childbirth
- Scientific TitleEMDR in pregnant women with PTSD after previous childbirth
- ACRONYMEMDR_PTSD
- hypothesisIn follow up measurements compared to pre-treatment measurement
1) WITHIN the treatment group there is a decline in the severity of PTSD symptoms and percentage of PTSD diagnoses;
2) BETWEEN treatment group and care-as-usual group there is more reduction in PTSD symptom severity, a lower percentage of PTSD diagnoses, fewer caesarean sections, a more positive childbirth experience, and lower health care costs in the treatment group;
3) EMDR does not lead to more obstetrical or neonatal complications.
- Healt Condition(s) or Problem(s) studiedPregnancy, Post traumatic stress disorder, Labour, EMDR, Post partum
- Inclusion criteriaMultiparae with a gestational age of 8-20 weeks, who master the Dutch language
- Exclusion criteria<18 years old,
current psychological treatment
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2015
- planned closingdate1-okt-2016
- Target number of participants50
- InterventionsCare-as-usual group: care-as-usual is defined as standard care during pregnancy, with routine obstetrical checks. Assuming good clinical care, anxious pregnant women and those with traumatic delivery experiences will receive more counseling compared to not-anxious pregnant women, but will (probably) not be referred for EMDR.

Eye Movement Desensitization and Reprocessing (EMDR) group: EMDR is a psychological intervention that was developed for the treatment of traumatic memories. It is internationally recognized as a first choice therapy for treating posttraumatic stress disorder. EMDR is conducted according to the Dutch translation of the basic EMDR protocol 2015, and is provided in 3 sessions of 90 minutes. Eye movements were applied as the distracting stimulus.
- Primary outcomeSeverity of PTSD
- Secondary outcomeObstetrical and neonatal complications, percentage of PTSD diagnoses, percentage caesarean sections, subjective childbirth experience, health care costs.
- TimepointsData will be collected at several timepoints:
-Screening (gestational age 8-20 weeks)
-T0:Pre-assessment (circa 20 weeks gestational age)
-In between sessions (every two weeks for care as usual)
-T1: Post-treatment antepartum (30-32 weeks gestational age)
-T2: Post-treatment postpartum (2-3months postpartum)
- Trial web sitewww.olvg.nl/optimum
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M.G. van Pampus
- CONTACT for SCIENTIFIC QUERIESDr. M.G. van Pampus
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG)
- Funding
(Source(s) of Monetary or Material Support)
Vereniging EMDR Nederland (VEN)
- Publications
- Brief summaryAfter childbirth, 1-3% of women will develop a posttraumatic stress disorder (PTSD). Many women will become pregnant again and experience severe anxiety associated with pregnancy and childbirth. Our objective is to assess efficacy and safety of EMDR treatment for pregnant women with PTSD after childbirth. After screening 1667-5000 multiparae, 50 pregnant women with PTSD will be randomized between care-as-usual or 3 sessions of 90 minutes EMDR.
- Main changes (audit trail)
- RECORD30-mrt-2015 - 31-mei-2015


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