Clinical trial NCT05489133: Early Psychological Intervention After Rape
Official title: Early Intervention After Rape to Prevent Post-traumatic Stress Disorder - a Multicenter Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: The Research Council of Norway
name: Norwegian Women's Public Health Association (Norske Kvinners Sanitetsforening)
name: National Centre for Emergency Primary Health Care, NORCE
name: UiT The Arctic University of Norway
First posted: 2022-08-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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).

Detailed description: 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, leading to severe mental and physical suffering. There is a lack of evidence-based knowledge how to prevent the development of PTSD after rape. Women may suffer from PTSD for years before receiving therapy.

Prolonged Exposure Therapy (PE) is well documented as a therapy. However, preventing the development of PTSD have the potential to spare women of the suffering, prevent both mental and somatic health problems, and also reduce health care costs. Currently a brief protocol based on PE, has been developed, modified prolonged exposure (mPE), 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.

Specialized services for victims, Sexual Assault Care (SAC) centers have been established in Norway, offering forensic documentation, medical treatment and psychosocial follow-up. The follow-up service varies widely and no evidence-based preventive measures have been implemented.

The investigators propose to conduct a multi-site (SAC centers in Trondheim, Oslo, and Sandefjord) randomized control trial (RCT) in which patients are recruited early after a rape, and randomized within 2 weeks to intervention (mPE) or treatment as usual (TAU).

The patients will be stratified by treatment center and randomized in permuted blocks of varying sizes according to a computer-generated randomization key prepared by the Clinical Research Unit at .

Around 800 patients will attend one of the four SACs per year. Based on experience from others the investigators anticipate that approximately 200 patients will be eligible and consenting to participation in this study and that around 50% of participants will dropout during the study period. A final sample size of 100 completed participants (50 in the intervention and 50 in TAU) will achieve 80% power to detect a standardized mean difference (SMD) of 0.44 for each of the primary outcomes in a design with 3 repeated measurements assuming an autoregressive, AR(1), covariance structure when the standard deviation is 1, the correlation between observations on the same subject is 0.5, and the alpha level is 0.05 (PASS Sample Size software - Tests for Two Means in Repeated Measures Design). Given the rather conservative estimate for inclusion, the investigators will need 1.5-2 years to recruit sufficient numbers.

Given the nested structure of the data - e.g., multiple measurement points nested within patients, patients nested within therapists, therapists nested within study sites - data will be analyzed by multilevel modeling. In addition, multilevel modeling is a robust method to deal with the missing data given the expected high percentage of drop-out from the study. The primary analysis will be an intention-to-treat analysis.

Predictors and moderators of the intervention, like stress response (measured by level of cortisol in hair and saliva) and sleep patterns (measured with actigraphy), will be explored.

The planned intervention is a brief and simple program, with large potential to be implemented as routines if proven effective, and thus inform clinical guidelines.

Eligibility 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

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: At 3 months follow-up
measure: PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5)
timeFrame: At 3 months follow-up
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: At 6 weeks, 3, 6 and 12 months
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: At 6 weeks, 3, 6 and 12 months
measure: Female Sexual Function Index (FSFI)
timeFrame: At 6 weeks, 3, 6 and 12 months
measure: Bergen insomnia scale (BIS)
timeFrame: At 6 weeks, 3, 6 and 12 months
measure: EQ-5D-5L
timeFrame: At 6 weeks, 3, 6 and 12 months
measure: The Amsterdam Hyperactive Pelvic Floor Scale for Women
timeFrame: At 6 weeks, 3, 6 and 12 months
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: At 6 weeks, 3, 6 and 12 months
measure: PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5)
timeFrame: At 6 weeks, 3, 6 and 12 months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Overgrepsmottaket Sør-Rogaland
state: In
city: Oslo
country: Norway
facility: Oslo Emergency Medical Agency (Oslo kommune, Legevakten, Overgrepsmottaket i Oslo)
city: Sandefjord
country: Norway
facility: Sandefjord Emergency Medical Agency (Legevakten, Overgrepsmottaket i Vestfold)
city: Trondheim
country: Norway
facility: Department of Obstetrics and Gynecology, St. Olavs hospital (Overgrepsmottaket)
Study officials:
affiliation: St. Olavs Hospital
name: Cecilie T Hagemann
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Olavs Hospital
name: Joar Ø Halvorsen
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.