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Completed

NCT Number: NCT03887689

Early Psychological Intervention After Rape

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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified prolonged exposure

Behavioral

Participants will receive three sessions of modified prolonged exposure therapy.

Primary outcomes

  1. CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)

    Time frame: Change 2 months (primary endpoint) after intervention

    Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD

Secondary outcomes

  1. PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)

    Time frame: Change 2 months after intervention

    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.

  2. Beck Depression Inventory (BDI)

    Time frame: Change 2 months after intervention

    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.

  3. Adverse Events

    Time frame: Change 2 months after intervention

    Number of adverse events from baseline to follow up 2 months

  4. WHO Disability Assessment Schedule (WHODAS)

    Time frame: Change 2 months after intervention

    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.

  5. Insomnia Severity Index (ISI)

    Time frame: Change 2 months after intervention

    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.

  6. Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: Change 2 months after intervention

    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.

  7. Intrusion diary

    Time frame: Change at week 1, week 2 and week 3 of the intervention.

    Change in self-report assessment of daily intrusions using a pen and stencil diary.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Early Psychological Intervention After Rape: a Feasibility Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 25, 2019
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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