Early Psychological Intervention After Rape

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Modified prolonged exposure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified prolonged exposure (add on)<br>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<br>* Imaginary and in vivo expo, in addition to psychoeducation<br>* Other names: cognitive behavioral therapy;|
| No Intervention: Treatment as usual (TAU)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a self-report questionnaire consisting of nine items measuring the severity of depressive symptoms. | At 6 weeks, 3, 6 and 12 months | 
| General Anxiety Disorder-7 (GAD-7) | GAD-7 is a self-report questionnaire consisting of seven items measuring the severity of symptoms of anxiety. | At 6 weeks, 3, 6 and 12 months | 
| Female Sexual Function Index (FSFI) | 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. | At 6 weeks, 3, 6 and 12 months | 
| Bergen insomnia scale (BIS) | 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 | 
| EQ-5D-5L | 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 | 
| The Amsterdam Hyperactive Pelvic Floor Scale for Women | 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 | 
| 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 6 weeks, 3, 6 and 12 months | 
| 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 6 weeks, 3, 6 and 12 months |