Early psychological help for women after rape
Early Intervention After Rape to Prevent Post-traumatic Stress Disorder - a Multicenter Randomized Control Trial
This study is testing a new therapy for women who have recently been raped to see if it can help prevent PTSD better than standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 4 sites (Stavanger, In and 3 other locations) |
| Trial ID | NCT05489133 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a modified protocol based on Prolonged Exposure Therapy (mPE) in preventing post-traumatic stress disorder (PTSD) among women who have recently experienced rape. The study will recruit women aged 16 and older from four Sexual Assault Care centers in Norway, who will be randomized to receive either the mPE intervention or standard treatment. The mPE consists of three to five sessions of therapy conducted within two weeks of the assault, focusing on addressing trauma symptoms early to mitigate long-term psychological effects. The trial seeks to provide evidence-based preventive measures for PTSD in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 16 and older who have recently experienced a sexual violation meeting specific trauma criteria.
Not a fit: Patients who may not benefit include those under 16 years of age, male biological gender, or those with severe cognitive or psychological impairments.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of PTSD among women who have experienced rape.
How similar studies have performed: Other studies have shown promise in using early psychological interventions to prevent PTSD, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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.) Exclusion Criteria: * Age \< 16 years * male biological gender * cognitive disability * acute psychosis * acute suicidal * severe alcohol/drug abuse * current treatment for PTSD * non-Norwegian speaking * total amnesia for the event
Where this trial is running
Stavanger, In and 3 other locations
- Overgrepsmottaket Sør-Rogaland — Stavanger, In, Norway (Recruiting)
- Oslo Emergency Medical Agency (Oslo kommune, Legevakten, Overgrepsmottaket i Oslo) — Oslo, Norway (Recruiting)
- Sandefjord Emergency Medical Agency (Legevakten, Overgrepsmottaket i Vestfold) — Sandefjord, Norway (Recruiting)
- Department of Obstetrics and Gynecology, St. Olavs hospital (Overgrepsmottaket) — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Cecilie T Hagemann — St. Olavs Hospital
- Study coordinator: Cecilie T Hagemann, PhD
- Email: cecilie.hagemann@ntnu.no
- Phone: 95829490
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.