Modified prolonged exposure therapy as Early Intervention after Rape (The EIR-study): study protocol for a multicenter randomized add-on superiority trial

• Type of Material: Article
• Authors: Tina Haugen, Norwegian University of Science and Technology (NTNU); Joar O Halvorsen, Norwegian University of Science and Technology (NTNU); Oddgeir Friborg, Arctic Univ Norway UiT; Melanie Rae Simpson, Norwegian University of Science and Technology (NTNU); Paul Jarle Mork, Norwegian University of Science and Technology (NTNU); Gustav Mikkelsen, Norwegian University of Science and Technology (NTNU); Ask Elklit, University of Southern Denmark; Barbara Rothbaum, Emory University; Berit Schei, Norwegian University of Science and Technology (NTNU); Cecilie Hagemann, Norwegian University of Science and Technology (NTNU)
• Language: English
• Date: 2023-02-21
• Publisher: BMC
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s) 2023, corrected publication 2023
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1186/s13063-023-07147-w
• Title of Journal or Parent Work: TRIALS
• Volume: 24
• Issue: 1
• Start Page: 126
• End Page: 126
• Grant/Funding Information: Open access funding provided by Norwegian University of Science and Technology. The EIR-study has received funding from the Research Council of Norway (project #320637), the Norwegian University of Science and Technology (NTNU), and the St. Olav hospital, Trondheim University hospital, Norway. The non-governmental organization Norwegian Women’s Public Health Association (NKS) is a collaborator in the project. The funding body has no role in the design of the study; the collection, analysis, and interpretation of the data; and in writing the manuscript.
• Keywords: FLOOR MUSCLE-ACTIVITY; INDEX FSFI; POSTTRAUMATIC-STRESS-DISORDER; Medicine, Research & Experimental; Life Sciences & Biomedicine; SCALE; HEALTH; Science & Technology; ASSAULT; Research & Experimental Medicine; CORTISOL; CONSEQUENCES; WOMEN; FEMALE SEXUAL FUNCTION
• Research Categories: Health Sciences, Obstetrics and Gynecology; Psychology, General

Abstract

Background: Sexual assault and rape are the traumatic life events with the highest probability for posttraumatic stress disorder (PTSD), which can have devastating consequences for those afflicted by the condition. Studies indicate that modified prolonged exposure (mPE) therapy may be effective in preventing the development of PTSD in recently traumatized individuals, and especially for people who have experienced sexual assault. If a brief, manualized early intervention can prevent or reduce post-traumatic symptoms in women who have recently experienced rape, healthcare services targeted for these populations (i.e., sexual assault centers, SACs) should consider implementing such interventions as part of routine care. Methods/design: This is a multicenter randomized controlled add-on superiority trial that enrolls patients attending sexual assault centers within 72 h after rape or attempted rape. The objective is to assess whether mPE shortly after rape can prevent the development of post-traumatic stress symptoms. Patients will be randomized to either mPE plus treatment as usual (TAU) or TAU alone. The primary outcome is the development of post-traumatic stress symptoms 3 months after trauma. Secondary outcomes will be symptoms of depression, sleep difficulties, pelvic floor hyperactivity, and sexual dysfunction. The first 22 subjects will constitute an internal pilot trial to test acceptance of the intervention and feasibility of the assessment battery. Discussion: This study will guide further research and clinical initiatives for implementing strategies for preventing post-traumatic stress symptoms after rape and provide new knowledge about which women may benefit the most from such initiatives and for revising existing treatment guidelines within this area. Trial registration: ClinicalTrials.gov NCT05489133. Registered on 3 August 2022