Early Intervention with Eye Movement Desensitization and Reprocessing to reduce PTSD symptom severity: A randomized controlled trial in recent rape victims.|
|- candidate number||28027|
|- NTR Number||NTR6760|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-okt-2017|
|- Secondary IDs||ABR 60551 NL60551.041.17|
|- Public Title||Early Intervention with Eye Movement Desensitization and Reprocessing to reduce PTSD symptom severity: A randomized controlled trial in recent rape victims.|
|- Scientific Title||Early Intervention with Eye Movement Desensitization and Reprocessing to reduce PTSD symptom severity: A randomized controlled trial in recent rape victims.|
|- ACRONYM||Early EMDR|
|- hypothesis||Victims of rape report significantly less PTSD symptoms at 4-,8- and 12-weeks follow up, after three sessions of Early EMDR therapy compared to TAU.|
|- Healt Condition(s) or Problem(s) studied||EMDR, Post-Traumatic Stress Disorder (PTSD), Randomized controlled trial, Sexual assault, Rape|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet the following criteria: |
- Present within 7 days post-rape at the Rape Centers in Utrecht, Leiden, Hoofddorp or Almere.
|- Exclusion criteria||- Age < 16 - Assault without penetration |
- Cognitive disability
- Acute psychosis
- Insufficient knowledge of the Dutch language
- Current intoxication
- Severe alcohol/drug abuse (substance treatment a priority)
- Acute suicidal ideation
- Current treatment (ad admittance) for PTSD
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2017|
|- planned closingdate||1-dec-2018|
|- Target number of participants||37|
|- Primary outcome||PTSD symptoms at 12 weeks, as measured with the CAPS(-CA)|
|- Secondary outcome||Dissociation, depression, sexual problems, anxiety|
|- Timepoints||2, 4, 8 and 12 weeks post-rape|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||dr. I.A.E. Bicanic|
|- CONTACT for SCIENTIFIC QUERIES||dr. I.A.E. Bicanic|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Stichting Achmea Slachtoffer en Samenleving , Innovatiefonds zorgverzekeraars, Vereniging EMDR Nederland (VEN), EMDR Europe|
|- Brief summary||After experiencing rape, the risk of developing post-traumatic stress disorder (PTSD) is high, with rates up to 40% three months post-rape (Möller, Bäckström, Torbjörn, Söndergaard & Helström, 2014; Rothbaum et al., 1992). As PTSD constitutes a major individual, societal and economic burden (Thielen et al., 2016; Olff et al., 2005), the prevention of PTSD gained much attention in recent decades. However, at present, there is no clear evidence-based preventive intervention for acutely traumatized individuals (Rose et al., 2002; Sijbrandij et al., 2006; Qi, Gevonden & Shalev, 2016). Clinical guidelines and expert consensus mainly suggest what not to do in the acute aftermath of trauma (NICE, 2005). At the same time, there is an urgent call for new initiatives in early interventions for trauma survivors, especially for incorporating existing evidence-based techniques into preventive interventions. In this study, we will investigate whether Eye Movement Desensitization and Reprocessing (EMDR) therapy at an early stage after rape can be efficacious in reducing PTSD symptoms. As far as we know, our study will be the first to investigate the efficacy of EMDR as a preventive intervention for acute rape victims using an randomize controlled trial. If the intervention proves effective, it may be broadly applicable in clinical practice. The study will also enhance knowledge with regard to acute psychological relief, aftercare of rape victims, and the possible mediating role of cognitive memory processing between experiences of dissociation and PTSD.|
Objective: To examine the efficacy of three sessions of Early EMDR therapy between day 14 and day 28 post-rape on the reduction of PTSD (symptoms) at 4, 8 and 12 weeks post-rape. The main research question is: 1. Do victims of rape report significantly less PTSD symptoms at 4-,8- and 12-weeks follow up, after three sessions of Early EMDR therapy compared to TAU?
Study design: The proposed study is a randomized controlled trial allocating subjects within 7 days post-rape, to either three sessions of Early EMDR Therapy or Treatment As Usual (TAU) in the time period 2-4 weeks post-rape, including a pre-treatment assessment at 2 weeks post-rape and post-treatment assessments at 4, 8 and 12 weeks post-rape. The participants will be assessed with regard to PTSD (symptomatology), degree of dissociation, sexual problems, image vividness and emotional intensity during recall of these images in the studied intervention, and comorbid psychopathology. The assessments have a quantitative (structured interview and questionnaires) nature.
Study population: Subjects are victims (age ≥16 years) of rape, who present themselves within 7 days post-rape at the Rape Centers at Leiden, Utrecht, Hoofddorp and Almere.
Primary study parameters/outcome of the study: The primary outcome is the participants’ level of PTSD symptom severity.
Secondary study parameters/outcome of the study:
Secondary measures include the degree of dissociation, vividness and emotional intensity of the images during recall in the Early EMDR condition and the participants’ level of comorbid psychopathology, with special attention to depression and sexual problems.
|- Main changes (audit trail)|
|- RECORD||18-okt-2017 - 4-nov-2017|
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