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PERCEIVE-study: Postpartum EaRly EMDR-therapy InterVention, a randomized controlled trial

PERCEIVE-study: Postpartum EaRly EMDR-therapy InterVention, a randomized controlled trial - PERCEIVE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54443
Enrollment
138
Registered
2020-05-15
Start date
2020-09-11
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-traumatic stress disorder (PTSD)

Interventions

Patients in the intervention group will receive two sessions of Early EMDR therapy consisting of sixty minutes each from a certified EMDR therapist. In EMDR therapy, the therapist aims to reduce the

Sponsors

OLVG
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • A traumatic delivery experience no more than two weeks prior to randomization. • Having sufficient command of the Dutch language, both verbally and in writing.

Exclusion criteria

Exclusion criteria: • Age<18 years old • Birth trauma related to a previous birth • Current/recent psychologic treatment or diagnosis. Recent meaning less than three months prior to the beginning of the study. • A history of a suicide attempt less than three months prior to beginning of treatment

Design outcomes

Primary

MeasureTime frame
Primary outcome measure is PTSD symptom severity as measured by the score on the PTSD Checklist for the DSM-5 (PCL-5; Boeschoten, Bakker, Jongedijk, & Olff, 2014) and the Clinician Administered PTSD Scale for DSM-5 nine weeks postpartum (CAPS-5; Boeschoten et al., 2018). PCL-5 The PCL-5 is a 20-item self-report questionnaire corresponding to the symptoms in the DSM-5 (APA,2010) and are rated from 0 (not at all) to 4 (extremely). A previous study found strong internal consistency, test-retest reliability, convergent validity and discriminant validity of the PCL-5 (Blevins, Weathers, Davis, Witte, & Domino, 2015). Monson et al. (2008) reported clinically significant change on a DSM-IV version of PCL to be 10 points. For the PCL-5, this clinically significant change has not been set yet. CAPS-5 PTSD diagnosis and symptom severity will be assessed by using the Dutch version of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5; Boeschoten et al., 2018; Weathers et al., 2013). The CAPS-5 is a structured clinical interview that enables standardized DSM-5 PTSD diagnosis based on symptom severity scores. Because all subjects in the present study suffered a traumatic birth experience, the interviewer does not assess Criterion A (identification of traumatic event). High validity and reliability of the CAPS-5 have been found (Boeschoten et al., 2018; Weathers et al., 2017).

Secondary

MeasureTime frame
World Health Organization Quality of Life assessment (WHOQOL-BREF) Quality of life is measured by using the Dutch version of the WHOQOL-BREF (WHOQOL Group, 1998). It contains 26 items covering four domains: physical health, psychological health, social relationships and environment. It has been validated for this specific population (Webster et al., 2010). Postpartum Bonding Questionnaire (PBQ) Mother to infant bonding is assessed by using the PBQ (Brockinton et al., 2001). It consists of 25 statements, each followed by a six-point Likert scale ranging from *Always*(0) to *Never*(5) with a range of 0-125 with higher scores reflecting a problematic mother-to-infant bond. Good validity and reliability of the Dutch version of the PBQ have been found (van Bussel & Spitz, 2010). To analyse the effects of PTSD symptom severity on the PBQ, only the total score will be used since later validation studies have not been able to replicate its factor structure. A validation study in 2006 found that a score of 26 achieved a specificity of 0.61, sensitivity 0.84 and positive predictive value of 0.79 between mothers without bonding problems and some kind of bonding disorder. A score of 40 or higher indicates severe bonding disorders with a specificity of 0.89 with respect to normal mothers, a sensitivity for rejecting mothers of 0.89 and severely angry mothers of 0.80. Wijma Delivery Experience Questionnaire version B (WDEQ-B) The WDEQ-B (Wijma et al., 1998) is used to measure postpartum fear of childbirth. The WDEQ is a 33-item self-report questionnaire assessing FoC during pregnancy (version A), and after delivery (version B) in terms of the woman*s cognitive appraisal of childbirth. It was designed as a monofactorial scale, all 33 items being scored on a six-point scale leading to a sum score between 0 and 165, with higher score equalling more FoC. The WDEQ can be dichotomized to conclude if there is FoC or not (cut-off >= 85). Internal consistency

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)