- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05489133
Early Psychological Intervention After Rape (EIR)
Early Intervention After Rape to Prevent Post-traumatic Stress Disorder - a Multicenter Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cecilie T Hagemann, PhD
- Phone Number: +47 95829490
- Email: cecilie.hagemann@ntnu.no
Study Contact Backup
- Name: Joar Ø Halvorsen, PhD
- Phone Number: +47 92256656
- Email: joar.halvorsen@ntnu.no
Study Locations
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Oslo, Norway, 0182
- Not yet recruiting
- Oslo Emergency Medical Agency (Oslo kommune, Legevakten, Overgrepsmottaket i Oslo)
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Contact:
- Tone Jeksrud, Master
- Phone Number: +4745295360
- Email: tone.jeksrud@hel.oslo.kommune.no
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Contact:
- Anne B Lunde
- Email: anne.berit.lunde@hel.oslo.kommune.no
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Sandefjord, Norway, 3247
- Not yet recruiting
- Sandefjord Emergency Medical Agency (Legevakten, Overgrepsmottaket i Vestfold)
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Contact:
- Linda M Gustavsen
- Phone Number: +4797596797
- Email: linda.molgaard.gustavsen@sandefjord.kommune.no
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Contact:
- Ruth C Grude
- Email: Ruth.Cecilie.Grude@sandefjord.kommune.no
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Trondheim, Norway, 7006
- Recruiting
- Department of Obstetrics and Gynecology, St. Olavs hospital (Overgrepsmottaket)
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Contact:
- Cecilie Hagemann, PhD
- Phone Number: +4795829490
- Email: cecilie.hagemann@ntnu.no
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Contact:
- Coordinator
- Phone Number: +4748117289
- Email: EIRstudien@stolav.no
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Modified prolonged exposure (add on)
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.
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Imaginary and in vivo expo, in addition to psychoeducation
Other Names:
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No Intervention: Treatment as usual (TAU)
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: At 3 months follow-up
|
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.
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At 3 months follow-up
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PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5)
Time Frame: At 3 months follow-up
|
The PSS-I-5 is a clinician-administered diagnostic interview measuring the 20 symptoms of PTSD as defined by DSM-5.
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At 3 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: At 6 weeks, 3, 6 and 12 months
|
The PHQ-9 is a self-report questionnaire consisting of nine items measuring the severity of depressive symptoms.
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At 6 weeks, 3, 6 and 12 months
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General Anxiety Disorder-7 (GAD-7)
Time Frame: At 6 weeks, 3, 6 and 12 months
|
GAD-7 is a self-report questionnaire consisting of seven items measuring the severity of symptoms of anxiety.
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At 6 weeks, 3, 6 and 12 months
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Female Sexual Function Index (FSFI)
Time Frame: At 6 weeks, 3, 6 and 12 months
|
The FSFI is a multidimensional self-report instrument for the assessment of female sexual function.
It contains 19 items divided into six subscales, and gives a total score of 2-36 by multiplying the sum of each subscale with a factor.
Mapi Research Trust, a non-profit, full-service provider, promoting the use of Clinical Outcomes Assessments (COAs) have given us permission to use the Norwegian version of the FSFI questionnaire in our study, a version we consider better than the one available on the FHI web-pages.
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At 6 weeks, 3, 6 and 12 months
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Bergen insomnia scale (BIS)
Time Frame: At 6 weeks, 3, 6 and 12 months
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Insomnia, questionnaire, quantitative, continous measure. The questionnaire contains 6 items relating to sleep and tiredness. Score 0 -7 (0 means no days during the course of a week, 7 means every day during the course of a week) on each item are summarized. Diagnostics for Insomnia: score ≥ 3 on at least one of the items 1 -4, and score ≥ 3 on at least one of the items 5-6) vs. No insomnia: score ≤ 2 on all items 1-4 or score ≤ 2 on both items 5-6 |
At 6 weeks, 3, 6 and 12 months
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EQ-5D-5L
Time Frame: At 6 weeks, 3, 6 and 12 months
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Quality of life: five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems (each scored 1-5). Included also is the EQ VAS that records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' (0-100). The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. |
At 6 weeks, 3, 6 and 12 months
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The Amsterdam Hyperactive Pelvic Floor Scale for Women
Time Frame: At 6 weeks, 3, 6 and 12 months
|
Questionnaire, translated and validated Norwegian version: The original questionnaire includes 30 items. Each item deals with one symptom and has a 5-point Likert scale varying from never (score 1) to very often (score 5). 25 of the 30 items are categorized into six different subscales: 1) vulvar pain symptoms; 2) abdominal pain and defecation symptoms; 3) micturition problems; 4) urinary tract infection; 5) rectal problems; and 6) physiological symptoms of general stress/tension. A total score is given from 6 to 30 where a low score (6,0 - 10,9) means "no hyperactivity" in the pelvic floor muscles, a medium score (11,0 - 12,9) means "mild hyperactivity" in the pelvic floor and a high score (13,0 - 30,0) means "moderate to severe hyperactivity" in the pelvic floor. |
At 6 weeks, 3, 6 and 12 months
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PTSD Checklist for DSM-5 (PCL-5)
Time Frame: At 6 weeks, 3, 6 and 12 months
|
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 6 weeks, 3, 6 and 12 months
|
PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5)
Time Frame: At 6 weeks, 3, 6 and 12 months
|
The PSS-I-5 is a clinician-administered diagnostic interview measuring the 20 symptoms of PTSD as defined by DSM-5.
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At 6 weeks, 3, 6 and 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cecilie T Hagemann, St. Olavs Hospital
- Study Director: Joar Ø Halvorsen, St. Olavs Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Wake Disorders
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Musculoskeletal Pain
- Trauma and Stressor Related Disorders
- Sexual Dysfunction, Physiological
- Vaginal Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Myalgia
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Dyssomnias
- Parasomnias
- Sexual Dysfunctions, Psychological
- Pelvic Pain
- Vaginismus
Other Study ID Numbers
- 348496
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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