Post Traumatic Stress Disorder
Conditions
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.
Interventions
BEHAVIORALModified prolonged exposure
Participants will receive three sessions of modified prolonged exposure therapy.
Sponsors
Karolinska Institutet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS) | Change 2 months (primary endpoint) after intervention | Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) | 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. |
| Beck Depression Inventory (BDI) | 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. |
| Adverse Events | Change 2 months after intervention | Number of adverse events from baseline to follow up 2 months |
| Insomnia Severity Index (ISI) | 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. |
| Multidimensional Scale of Perceived Social Support (MSPSS) | 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. |
| Intrusion diary | 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. |
| WHO Disability Assessment Schedule (WHODAS) | 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. |
Outcome results
None listed