Clinical trial NCT03887689: Early Psychological Intervention After Rape
Official title: Early Psychological Intervention After Rape: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
timeFrame: Change 2 months (primary endpoint) after intervention
Secondary outcomes:
measure: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
timeFrame: Change 2 months after intervention
measure: Beck Depression Inventory (BDI)
timeFrame: Change 2 months after intervention
measure: Adverse Events
timeFrame: Change 2 months after intervention
measure: WHO Disability Assessment Schedule (WHODAS)
timeFrame: Change 2 months after intervention
measure: Insomnia Severity Index (ISI)
timeFrame: Change 2 months after intervention
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Change 2 months after intervention
measure: Intrusion diary
timeFrame: Change at week 1, week 2 and week 3 of the intervention.
Other outcomes:
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