Early Psychological Intervention After Rape

NCT ID: NCT03887689

Last Updated: 2019-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-11

Study Completion Date

2017-04-04

Brief Summary

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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

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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.

Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Modified prolonged exposure

Participants will receive three sessions of modified prolonged exposure therapy.

Group Type EXPERIMENTAL

Modified prolonged exposure

Intervention Type BEHAVIORAL

Participants will receive three sessions of modified prolonged exposure therapy.

Interventions

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Modified prolonged exposure

Participants will receive three sessions of modified prolonged exposure therapy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Erik Andersson

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2016/2194-31

Identifier Type: -

Identifier Source: org_study_id

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