Early Psychological Intervention After Rape

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Behavioral: Modified prolonged exposure

• Registration Number: NCT03887689
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-11
• Primary Completion: 2017-04-04
• Study Completion: 2017-04-04
• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-25
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified prolonged exposure	Modified prolonged exposure	Participants will receive three sessions of modified prolonged exposure therapy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)	Change 2 months after intervention	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.
Beck Depression Inventory (BDI)	Change 2 months after intervention	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.
Adverse Events	Change 2 months after intervention	Number of adverse events from baseline to follow up 2 months
WHO Disability Assessment Schedule (WHODAS)	Change 2 months after intervention	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.
Insomnia Severity Index (ISI)	Change 2 months after intervention	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.
Multidimensional Scale of Perceived Social Support (MSPSS)	Change 2 months after intervention	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.
Intrusion diary	Change at week 1, week 2 and week 3 of the intervention.	Change in self-report assessment of daily intrusions using a pen and stencil diary.