Title	Modified prolonged exposure therapy as an Early Intervention after Rape (The EIR-study): Study protocol for a multicenter randomized add-on superiority trial.
Trial registration	The trial has been registered in the clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT05489133) Aug 3, 2022.
Protocol version	Protocol version 2.0 is currently active.
Funding	The EIR-study has received funding from the Research Council of Norway (project #320637), the Department of Clinical and Molecular Medicine, the Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), and from the Department of Obstetrics and Gynecology, St. Olavs hospital, Trondheim University Hospital. The non-governmental organization Norwegian Women's Public Health Association (N.K.S.) is a collaborator in the project.
Roles and responsibilities: contributorship	Names, affiliations, and roles of protocol contributors: Cecilie Hagemann, Principal Investigator. Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU). Department of Obstetrics and Gynecology, St. Olavs hospital, Trondheim University Hospital. cecilie.hagemann@ntnu.no Joar Øveraas Halvorsen, Co-Principal Investigator. Department of Psychology, Norwegian University of Science and Technology (NTNU). St. Olavs hospital, Trondheim University Hospital. joar.halvorsen@ntnu.no Berit Schei, Associate Investigator. Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU). Department of Obstetrics and Gynecology, St. Olavs hospital, Trondheim University Hospital. berit.schei@ntnu.no Tina Haugen, Associate Investigator, PhD candidate. Department psychology and Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU). St. Olavs hospital, Trondheim University Hospital. tina.haugen@ntnu.no Oddgeir Friborg, Associate Investigator. Department of Psychology, The Arctic University of Norway. (UiT). oddgeir.friborg@uit.no Melanie Rae Simpson, Trial statistician. Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU). melanie.simpson@ntnu.no Paul Jarle Mork, Associate Consultant. Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU). paul.mork@ntnu.no Gustav Mikkelsen, Associate Consultant. Department of clinical chemistry, St. Olavs hospital, Trondheim University Hospital. Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU). Gustav.mikkelsen@stolav.no Ask Elklit, Associate Consultant. National Center for Psychotraumatology, University of Southern Denmark. aelklit@health.sdu.dk Barbara O. Rothbaum, Associate Consultant. Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine. brothba@emory.edu
Name and contact information for the trial sponsor	St Olavs hospital HF, Pb. 3250 Torgarden. 7006 Trondheim.
Roles and responsibilities: sponsor and funder	The sponsor covers indemnity insurances and legal liability for this study, and funds research infrastructure such as general, personnel expenses, data collecting systems and secure data storage. This study is an investigator-initiated study; hence, the public funding organization (Research Council of Norway) has no role in formulations of hypotheses and study design, data collection, analyses, interpretation of the data or in writing of the manuscript.