Early Psychological Intervention After Rape

NCT05489133 | Recruiting DMC

• 1 other identifier: 348496
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Post Traumatic Stress Disorder; Rape Sexual Assault; Sexual Dysfunctions, Psychological; Pelvic Floor Myalgia; Pelvic Pain Syndrome; Depression, Anxiety; Sleep Disturbance; Activity, Motor; Cortisol Deficiency

Outcome Measures

Primary Outcomes (2)

• PTSD Checklist for DSM-5 (PCL-5)

  The PCL-5 is a self-report questionnaire consisting of 20 items corresponding to the 20 symptoms of PTSD as defined by DSM-5. Patients rate their posttraumatic symptoms on a Likert scale from 0-4. The continuous sum score of the PCL-5 will de the primary outcome.

  At 3 months follow-up

• PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5)

  The PSS-I-5 is a clinician-administered diagnostic interview measuring the 20 symptoms of PTSD as defined by DSM-5.

  At 3 months follow-up

Secondary Outcomes (8)

• Patient Health Questionnaire-9 (PHQ-9)

  At 6 weeks, 3, 6 and 12 months

• General Anxiety Disorder-7 (GAD-7)

  At 6 weeks, 3, 6 and 12 months

• Female Sexual Function Index (FSFI)

  At 6 weeks, 3, 6 and 12 months

• Bergen insomnia scale (BIS)

  At 6 weeks, 3, 6 and 12 months

• EQ-5D-5L

  At 6 weeks, 3, 6 and 12 months

Study Arms (2)

Modified prolonged exposure (add on)

EXPERIMENTAL

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.

Behavioral: Modified prolonged exposure

Treatment as usual (TAU)

NO INTERVENTION

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.

Interventions

Modified prolonged exposure BEHAVIORAL

Imaginary and in vivo expo, in addition to psychoeducation

Also known as: Brief intervention, cognitive behavioral therapy

Modified prolonged exposure (add on)

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Many of the vaildated questionnaires are based on the presence of female genital organs, hence, we have chosen to include only genetical and phenotypical females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator
• The Research Council of Norway: collaborator
• Norwegian Women's Public Health Association (Norske Kvinners Sanitetsforening): collaborator
• National Centre for Emergency Primary Health Care, NORCE: collaborator
• UiT The Arctic University of Norway: collaborator

Study Sites (4)

Overgrepsmottaket Sør-Rogaland

Stavanger, In, Norway

RECRUITING

Oslo Emergency Medical Agency (Oslo kommune, Legevakten, Overgrepsmottaket i Oslo)

Oslo, 0182, Norway

RECRUITING

Sandefjord Emergency Medical Agency (Legevakten, Overgrepsmottaket i Vestfold)

Sandefjord, 3247, Norway

RECRUITING

Department of Obstetrics and Gynecology, St. Olavs hospital (Overgrepsmottaket)

Trondheim, 7006, Norway

RECRUITING

Related Publications (3)

• Haugen T, Halvorsen JO, Friborg O, Mork PJ, Mikkelsen G, Schei B, Hagemann C. Early Intervention after Rape to prevent post-traumatic stress symptoms (the EIR-study): an internal pilot study of a randomized controlled trial. Pilot Feasibility Stud. 2024 Sep 2;10(1):118. doi: 10.1186/s40814-024-01541-0.

  PMID: 39223617 RESULT

• Haugen T, Halvorsen JO, Friborg O, Simpson MR, Mork PJ, Mikkelsen G, Elklit A, Rothbaum BO, Schei B, Hagemann C. Modified prolonged exposure therapy as Early Intervention after Rape (The EIR-study): study protocol for a multicenter randomized add-on superiority trial. Trials. 2023 Feb 21;24(1):126. doi: 10.1186/s13063-023-07147-w.

  PMID: 36810120 RESULT

• Haugen T, Halvorsen JO, Friborg O, Schei B, Hagemann CT, Kjelsvik M. Therapists perspectives on the Early Intervention after Rape study: a qualitative process evaluation of a randomized controlled trial. Eur J Psychotraumatol. 2025 Dec;16(1):2443279. doi: 10.1080/20008066.2024.2443279. Epub 2025 Jan 7.

  PMID: 39773406 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sexual Dysfunctions, Psychological; Vaginismus; Depression; Anxiety Disorders; Parasomnias; Motor Activity

Interventions

Crisis Intervention; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Behavioral Symptoms; Behavior; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy

Study Officials

• Cecilie T Hagemann

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

• Joar Ø Halvorsen

  St. Olavs Hospital

  STUDY DIRECTOR

Central Study Contacts

Cecilie T Hagemann, PhD

CONTACT

95829490; cecilie.hagemann@ntnu.no

Joar Ø Halvorsen, PhD

CONTACT

92256656; joar.halvorsen@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Primary objective is to test whether a psychological intervention with modified prolonged exposure (mPE) therapy is superior to treatment as usual (TAU) to prevent the development of PTSD.

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: August 5, 2022
• Study Start: June 14, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (4)