Early Intervention After Rape to Prevent Post-traumatic Stress Disorder - a Multicenter Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 166
- 试验地点
- 8
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
Rape is a common cause of post-traumatic stress disorder (PTSD) among women, as around 30-50% will develop PTSD in the aftermath of rape. A modified protocol based on Prolonged Exposure Therapy (mPE), has been developed, consisting of three to five once or twice weekly 60 minutes sessions, and studies indicate that if implemented early after rape, mPE may prevent the development of PTSD. The aim of the study is to conduct a multi-site (4 Sexual assault care centers in Norway) randomized control trial (RCT) in which patients are recruited early after rape, and randomized to intervention (mPE) or treatment as usual (TAU).
详细描述
Rape is a common cause of post-traumatic stress disorder (PTSD) among women, as around 30-50% will develop PTSD in the aftermath of rape, leading to severe mental and physical suffering. There is a lack of evidence-based knowledge how to prevent the development of PTSD after rape. Women may suffer from PTSD for years before receiving therapy.
Prolonged Exposure Therapy (PE) is well documented as a therapy. However, preventing the development of PTSD have the potential to spare women of the suffering, prevent both mental and somatic health problems, and also reduce health care costs. Currently a brief protocol based on PE, has been developed, modified prolonged exposure (mPE), consisting of three to five once or twice weekly 60 minutes sessions, and studies indicate that if implemented early after rape, mPE may prevent the development of PTSD.
Specialized services for victims, Sexual Assault Care (SAC) centers have been established in Norway, offering forensic documentation, medical treatment and psychosocial follow-up. The follow-up service varies widely and no evidence-based preventive measures have been implemented.
The investigators propose to conduct a multi-site (SAC centers in Trondheim, Oslo, and Sandefjord) randomized control trial (RCT) in which patients are recruited early after a rape, and randomized within 2 weeks to intervention (mPE) or treatment as usual (TAU).
The patients will be stratified by treatment center and randomized in permuted blocks of varying sizes according to a computer-generated randomization key prepared by the Clinical Research Unit at .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 16 years of age
- •attending after a trauma meeting the DSM V trauma definition criterion "sexual violation" (in this context, characterized by penetration in any body orifice, by penis, finger, foreign body, but also attempted penetration leading to a sufficient mental reaction, helplessness, without control, intense fear etc.)
排除标准
- •Age < 16 years
- •male biological gender
- •cognitive disability
- •acute psychosis
- •acute suicidal
- •severe alcohol/drug abuse
- •current treatment for PTSD
- •non-Norwegian speaking
- •total amnesia for the event
研究组 & 干预措施
Treatment as usual (TAU)
Standard care at the sexual assault center (SAC), that is mostly nurse-/social worker-led psychoeducation at varying intervals and extent, and medical follow-up at the SAC.
Modified prolonged exposure (add on)
The psychological intervention modified Prolonged Exposure Therapy (mPE) is applied, in addition to Treatment as usual (TAU) (that is, an Add-on). mPE is a trauma-focused evidence-based cognitive behavioral therapy (CBT) shown to be effective in treating PTSD. We will use imaginal exposure in the sessions with the patient describing the traumatic event in detail while being recorded for later listening and homework, and in vivo exposure for visiting specific places or people. Psychoeducation and controlled breathing exercises play a secondary role in PE. We have adapted the mPE to the current SAC settings in Norway where nurses or social workers, not psychologist, as a rule are performing the psychosocial follow-up for rape victims. In this project we plan for three to five once or twice weekly nurse-/social worker-led mPE interventions, given early after the assault.
干预措施: Modified prolonged exposure (Behavioral)
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: At 3 months follow-up
The PCL-5 is a self-report questionnaire consisting of 20 items corresponding to the 20 symptoms of PTSD as defined by DSM-5. Patients rate their posttraumatic symptoms on a Likert scale from 0-4. The continuous sum score of the PCL-5 will de the primary outcome.
PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5)
时间窗: At 3 months follow-up
The PSS-I-5 is a clinician-administered diagnostic interview measuring the 20 symptoms of PTSD as defined by DSM-5.
次要结局
- General Anxiety Disorder-7 (GAD-7)(At 6 weeks, 3, 6 and 12 months)
- Patient Health Questionnaire-9 (PHQ-9)(At 6 weeks, 3, 6 and 12 months)
- Female Sexual Function Index (FSFI)(At 6 weeks, 3, 6 and 12 months)
- EQ-5D-5L(At 6 weeks, 3, 6 and 12 months)
- The Amsterdam Hyperactive Pelvic Floor Scale for Women(At 6 weeks, 3, 6 and 12 months)
- Bergen insomnia scale (BIS)(At 6 weeks, 3, 6 and 12 months)
- PTSD Checklist for DSM-5 (PCL-5)(At 6 weeks, 3, 6 and 12 months)
- PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5)(At 6 weeks, 3, 6 and 12 months)