Early Intervention After Rape to Prevent Post-traumatic Stress Disorder - a Multicenter Randomized Control Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Rape is a common cause of post-traumatic stress disorder (PTSD) among women, as around 30-50% will develop PTSD in the aftermath of rape. A modified protocol based on Prolonged Exposure Therapy (mPE), has been developed, consisting of three to five once or twice weekly 60 minutes sessions, and studies indicate that if implemented early after rape, mPE may prevent the development of PTSD. The aim of the study is to conduct a multi-site (4 Sexual assault care centers in Norway) randomized control trial (RCT) in which patients are recruited early after rape, and randomized to intervention (mPE) or treatment as usual (TAU).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: f
View:

• Women ≥ 16 years of age

• attending after a trauma meeting the DSM V trauma definition criterion sexual violation (in this context, characterized by penetration in any body orifice, by penis, finger, foreign body, but also attempted penetration leading to a sufficient mental reaction, helplessness, without control, intense fear etc.)

Locations
Other Locations
Norway
Oslo Emergency Medical Agency (Oslo kommune, Legevakten, Overgrepsmottaket i Oslo)
RECRUITING
Oslo
Sandefjord Emergency Medical Agency (Legevakten, Overgrepsmottaket i Vestfold)
RECRUITING
Sandefjord
Overgrepsmottaket Sør-Rogaland
RECRUITING
Stavanger
Department of Obstetrics and Gynecology, St. Olavs hospital (Overgrepsmottaket)
RECRUITING
Trondheim
Contact Information
Primary
Cecilie T Hagemann, PhD
cecilie.hagemann@ntnu.no
95829490
Backup
Joar Ø Halvorsen, PhD
joar.halvorsen@ntnu.no
92256656
Time Frame
Start Date: 2022-06-14
Estimated Completion Date: 2027-03
Participants
Target number of participants: 200
Treatments
Experimental: Modified prolonged exposure (add on)
The psychological intervention modified Prolonged Exposure Therapy (mPE) is applied, in addition to Treatment as usual (TAU) (that is, an Add-on). mPE is a trauma-focused evidence-based cognitive behavioral therapy (CBT) shown to be effective in treating PTSD. We will use imaginal exposure in the sessions with the patient describing the traumatic event in detail while being recorded for later listening and homework, and in vivo exposure for visiting specific places or people. Psychoeducation and controlled breathing exercises play a secondary role in PE. We have adapted the mPE to the current SAC settings in Norway where nurses or social workers, not psychologist, as a rule are performing the psychosocial follow-up for rape victims. In this project we plan for three to five once or twice weekly nurse-/social worker-led mPE interventions, given early after the assault.
No_intervention: Treatment as usual (TAU)
Standard care at the sexual assault center (SAC), that is mostly nurse-/social worker-led psychoeducation at varying intervals and extent, and medical follow-up at the SAC.
Sponsors
Collaborators: The Research Council of Norway, UiT The Arctic University of Norway, Norwegian Women's Public Health Association (Norske Kvinners Sanitetsforening), National Centre for Emergency Primary Health Care, NORCE, Norwegian University of Science and Technology
Leads: St. Olavs Hospital

This content was sourced from clinicaltrials.gov