Early Psychological Intervention After Rape: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Modified prolonged exposure
Participants will receive three sessions of modified prolonged exposure therapy.
干预措施: Modified prolonged exposure (Behavioral)
结局指标
主要结局
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
时间窗: Change 2 months (primary endpoint) after intervention
Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
次要结局
- PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)(Change 2 months after intervention)
- Beck Depression Inventory (BDI)(Change 2 months after intervention)
- Adverse Events(Change 2 months after intervention)
- WHO Disability Assessment Schedule (WHODAS)(Change 2 months after intervention)
- Insomnia Severity Index (ISI)(Change 2 months after intervention)
- Multidimensional Scale of Perceived Social Support (MSPSS)(Change 2 months after intervention)
- Intrusion diary(Change at week 1, week 2 and week 3 of the intervention.)
研究者
Erik Andersson
Principal investigator
Karolinska Institutet