Early Psychological Intervention After Rape

Study Overview
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Brief Summary
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The aim of the study is to translate and adapt a brief treatment protocol based on prolonged exposure provided within 72 hours after a rape to a Swedish context and pilot test feasibility and delivery in ten executive patients recruited at the Emergency Clinic for Rape victims in Stockholm.

Detailed Description
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The aim of the study is to translate and adapt a brief treatment protocol based on prolonged exposure provided within 72 hours after a rape to a Swedish context and pilot test feasibility and delivery in ten executive patients recruited at the Emergency Clinic for Rape victims in Stockholm. ENDPOINTS The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), Beck Depression Inventory (BDI) at baseline and post-treatment. Insomnia Severity Index (ISI) , Multidimensional Scale of Perceived Social Support (MSPSS), World Health Organization Disability Assessment Schedule(WHODAS-12) at post-treatment.The clinician-administered PTSD scale for DSM-5 (CAPS-5) at follow up. Data on feasibility aspects of the intervention will also be collected: compliance to the intervention/homework/assessments, possibilities to recruit, adverse events. Recruitment The investigatorors will recruit ten consecutive patients attending at the Emergency Clinic for Rape victims at Stockholm South Hospital, Sweden. Safety parameters Participants had the opportunity to report any adverse events during treatment, at posttreatment and follow-up.

Official Title
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Early Psychological Intervention After Rape: a Feasibility Study

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Modified prolonged exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Attending at the Emergency Clinic for Rape victims at Stockholm South Hospital, Sweden within 72 hours after experiencing a rape) Remembered the event. Exclusion Criteria: ongoing suicidal ideation or attempted suicide within the last two months ongoing self-harm behavior ongoing intoxication other serious psychiatric comorbidity (ongoing psychotic symptoms or manic episode) low cognitive capacity not fluent in Swedish subjected to ongoing violence or threat

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified prolonged exposure<br>Participants will receive three sessions of modified prolonged exposure therapy. | Behavioral: Modified prolonged exposure<br>* Participants will receive three sessions of modified prolonged exposure therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS) | Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD | Change 2 months (primary endpoint) after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) | Change in symptoms of post traumatic stress from post treatment and follow up (2 months). The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. All items are scored on a 0-4 scale. Higher score indicate worse severity. | Change 2 months after intervention | 
| Beck Depression Inventory (BDI) | Change in depressive symptoms from baseline to post treatment and follow up (2 months). The BDI is a 21 item self-report measure that assesses the presence and severity of depressive symptoms. All items are scored on a 0-3 scale. Higher score indicate worse severity. | Change 2 months after intervention | 
| Adverse Events | Number of adverse events from baseline to follow up 2 months | Change 2 months after intervention | 
| WHO Disability Assessment Schedule (WHODAS) | Measure of general health and function. The WHODAS-12 is a 12 item self-report measure that assesses overall health and functioning. All items are scored on a 0-4 scale. Higher score indicate worse severity. | Change 2 months after intervention | 
| Insomnia Severity Index (ISI) | Self-report questionnaire regarding insomnia. The ISI is a 12 item self-report measure that assesses sleep quality. All items are scored on a 0-4 scale. Higher score indicate worse severity. | Change 2 months after intervention | 
| Multidimensional Scale of Perceived Social Support (MSPSS) | A measure to assess for social support. MSPSS is a 7 item self-report measure that assesses aspects of social support. All items are scored on a 0-7 scale. Lower score indicate worse severity. | Change 2 months after intervention | 
| Intrusion diary | Change in self-report assessment of daily intrusions using a pen and stencil diary. | Change at week 1, week 2 and week 3 of the intervention. |