Early Psychological Intervention After Rape

Post Traumatic Stress Disorder Clinical Trial

Official title:

Early Psychological Intervention After Rape: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887689
• Other study ID #: 2016/2194-31
• Status: Completed
• Phase: N/A
• Start date: January 11, 2017
• Est. completion date: April 4, 2017

Study information

• Verified date: August 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 4, 2017
• Est. primary completion date: April 4, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Modified prolonged exposure
Participants will receive three sessions of modified prolonged exposure therapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Adverse Events	Number of adverse events from baseline to follow up 2 months	Change 2 months after intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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.