Modified prolonged exposure therapy as Early Intervention after Rape (The EIR-study): study protocol for a multicenter randomized add-on superiority trial
Haugen, Tina; Halvorsen, Joar Øveraas; Friborg, Oddgeir; Simpson, Melanie Rae; Mork, Paul Jarle; Mikkelsen, Gustav; Elklit, Ask; Rothbaum, Barbara O.; Schei, Berit; Hagemann, Cecilie Therese
Peer reviewed, Journal article
Published version
Permanent lenke
https://hdl.handle.net/11250/3063226Utgivelsesdato
2023Metadata
Vis full innførselSamlinger
- Fakultet for medisin og helsevitenskap (uspesifisert) [762]
- Institutt for klinisk og molekylær medisin [3426]
- Institutt for psykologi [2886]
- Institutt for samfunnsmedisin og sykepleie [3547]
- Publikasjoner fra CRIStin - NTNU [37221]
- Publikasjoner fra Cristin - St. Olavs hospital [1459]
- St. Olavs hospital [2441]
Originalversjon
10.1186/s13063-023-07147-wSammendrag
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