No registrations found.
ID
Source
Brief title
Health condition
Rape, Sexual Assault, PTSD, EMDR, RCT, Early Intervention
Sponsors and support
Intervention
Outcome measures
Primary outcome
PTSD symptoms at 12 weeks, as measured with the CAPS(-CA)
Secondary outcome
Dissociation, depression, sexual problems, anxiety
Background 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 two 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 two 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 two 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.
Study objective
Victims of rape report significantly less PTSD symptoms at 4-,8- and 12-weeks follow up, after two sessions of Early EMDR therapy compared to TAU.
Study design
2, 4, 8 and 12 weeks post-rape
Intervention
EMDR
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL6586 |
NTR-old | NTR6760 |
Other | NL60551.041.17 : ABR 60551 |