Early Psychological Intervention After Rape
1 other identifier
interventional
10
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2017
CompletedFirst Submitted
Initial submission to the registry
March 21, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedAugust 16, 2019
August 1, 2019
3 months
March 21, 2019
August 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Change 2 months after intervention
Beck Depression Inventory (BDI)
Change 2 months after intervention
Adverse Events
Change 2 months after intervention
WHO Disability Assessment Schedule (WHODAS)
Change 2 months after intervention
Insomnia Severity Index (ISI)
Change 2 months after intervention
- +2 more secondary outcomes
Study Arms (1)
Modified prolonged exposure
EXPERIMENTALParticipants will receive three sessions of modified prolonged exposure therapy.
Interventions
Participants will receive three sessions of modified prolonged exposure therapy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 21, 2019
First Posted
March 25, 2019
Study Start
January 11, 2017
Primary Completion
April 4, 2017
Study Completion
April 4, 2017
Last Updated
August 16, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share