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Early Psychological Intervention After Rape

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified prolonged exposure
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Modified prolonged exposure

    Arm Description

    Participants will receive three sessions of modified prolonged exposure therapy.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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.
    Adverse Events
    Number of adverse events from baseline to follow up 2 months
    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.
    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.
    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.
    Intrusion diary
    Change in self-report assessment of daily intrusions using a pen and stencil diary.

    Full Information

    First Posted
    March 21, 2019
    Last Updated
    August 14, 2019
    Sponsor
    Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03887689
    Brief Title
    Early Psychological Intervention After Rape
    Official Title
    Early Psychological Intervention After Rape: a Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 11, 2017 (Actual)
    Primary Completion Date
    April 4, 2017 (Actual)
    Study Completion Date
    April 4, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Traumatic Stress Disorder

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Modified prolonged exposure
    Arm Type
    Experimental
    Arm Description
    Participants will receive three sessions of modified prolonged exposure therapy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Modified prolonged exposure
    Intervention Description
    Participants will receive three sessions of modified prolonged exposure therapy.
    Primary Outcome Measure Information:
    Title
    CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
    Description
    Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
    Time Frame
    Change 2 months (primary endpoint) after intervention
    Secondary Outcome Measure Information:
    Title
    PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
    Description
    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.
    Time Frame
    Change 2 months after intervention
    Title
    Beck Depression Inventory (BDI)
    Description
    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.
    Time Frame
    Change 2 months after intervention
    Title
    Adverse Events
    Description
    Number of adverse events from baseline to follow up 2 months
    Time Frame
    Change 2 months after intervention
    Title
    WHO Disability Assessment Schedule (WHODAS)
    Description
    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.
    Time Frame
    Change 2 months after intervention
    Title
    Insomnia Severity Index (ISI)
    Description
    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.
    Time Frame
    Change 2 months after intervention
    Title
    Multidimensional Scale of Perceived Social Support (MSPSS)
    Description
    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.
    Time Frame
    Change 2 months after intervention
    Title
    Intrusion diary
    Description
    Change in self-report assessment of daily intrusions using a pen and stencil diary.
    Time Frame
    Change at week 1, week 2 and week 3 of the intervention.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Early Psychological Intervention After Rape

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