Early Psychological Intervention After Rape

Early Intervention After Rape to Prevent Post-traumatic Stress Disorder - a Multicenter Randomized Control Trial

Sponsors

Lead Sponsor: St. Olavs Hospital

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

Source St. Olavs Hospital
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, Sandefjord, and Fredrikstad) 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.

Overall Status Recruiting
Start Date 2022-06-14
Completion Date 2027-12-01
Primary Completion Date 2025-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
PTSD Checklist for DSM-5 (PCL-5) At 3 months follow-up
PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5) At 3 months follow-up
Secondary Outcome
Measure Time Frame
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
The Amsterdam Hyperactive Pelvic Floor Scale for Women At 6 weeks, 3, 6 and 12 months
PTSD Checklist for DSM-5 (PCL-5) At 6 weeks, 3, 6 and 12 months
PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5) At 6 weeks, 3, 6 and 12 months
Enrollment 200
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Modified prolonged exposure

Description: Imaginary and in vivo expo, in addition to psychoeducation

Arm Group Label: Modified prolonged exposure (add on)

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

Gender:

Female

Gender Based:

Yes

Gender Description:

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

Minimum Age:

16 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Cecilie T Hagemann, PhD

Phone: 95829490

Phone Ext.: +47

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup:
Fredrikstad Emergency Medical Agency (legevakt) (Overgrepsmottaket i Østfold) | Fredrikstad, 1671, Norway Not yet recruiting Ann H Lomsdalen +4795430873 [email protected]
Oslo Emergency Medical Agency (Oslo kommune, Legevakten, Overgrepsmottaket i Oslo) | Oslo, 0182, Norway Not yet recruiting Tone Jeksrud, Master +4745295360 [email protected]
Sandefjord Emergency Medical Agency (Legevakten, Overgrepsmottaket i Vestfold) | Sandefjord, 3247, Norway Not yet recruiting Linda M Gustavsen +4797596797 [email protected]
Department of Obstetrics and Gynecology, St. Olavs hospital (Overgrepsmottaket) | Trondheim, 7006, Norway Recruiting Cecilie Hagemann, PhD +4795829490 [email protected]
Location Countries

Norway

Verification Date

2022-08-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Modified prolonged exposure (add on)

Type: Experimental

Description: 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.

Label: Treatment as usual (TAU)

Type: No Intervention

Description: 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.

Acronym EIR
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Masking: Double (Investigator, Outcomes Assessor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Traumatic Stress Disorder

Clinical Trials on Modified prolonged exposure