Early Psychological Intervention After Rape

Early Psychological Intervention After Rape: a Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Modified prolonged exposure

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified prolonged exposure; Participants will receive three sessions of modified prolonged exposure therapy.	Behavioral: Modified prolonged exposure; Participants will receive three sessions of modified prolonged exposure therapy.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2017
• Primary Completion (Actual): April 4, 2017
• Study Completion (Actual): April 4, 2017

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2016/2194-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No