Early Support After Exposure to Trauma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 31
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5; Norwegian version)
研究概览
简要总结
A significant proportion of people who are exposed to traumatic events suffer from post-traumatic sequelae, such as post-traumatic stress disorder (PTSD). Indicated preventive interventions soon after trauma could be appropriate. Yet, there is limited evidence for the efficacy of such interventions. Moreover, no evidence-based preventive interventions are readily available for victims in the aftermath of crises and disasters in Norway. Condensed Internet-delivered Prolonged Exposure (CIPE) is a preventive intervention designed for victims with symptoms of PTSD (PTSS) approximately one month after a traumatic event. The treatment is an internet-delivered, therapist assisted intervention, based on principles from Prolonged Exposure. CIPE has proven to be feasible, safe, and effective in previous studies. This study aims to test the effectiveness and cost-effectiveness of CIPE in the context of psychosocial crisis services in Norwegian municipalities.
Hypotheses Effectiveness H1 Participants receiving CIPE + treatment as usual (TAU) will have significantly less PTSS than participants receiving TAU at 6 weeks post T1, and at 6-, and 12- months after the traumatic incident.
H2 Significantly fewer participants receiving CIPE+TAU will fulfill the criteria for PTSD compared to participants receiving TAU, at 6- and 12-months post trauma.
H3 Participants receiving CIPE+TAU will have significantly less symptoms of depression and insomnia than participants receiving TAU at 6 weeks post T1, and at 6-, and 12- months after the traumatic incident.
H4 Participants in the CIPE+TAU-condition will report significantly higher treatment satisfaction at post-treatment, compared to those in the TAU-condition.
H5 Participants with traumatic loss receiving CIPE+TAU will have significantly less symptoms of prolonged grief than such participants receiving TAU 12 months after the loss.
Cost-effectiveness H6 Fewer participants in the CIPE+TAU-condition will be referred to second-tier specialty mental health services, and more will achieve improved quality of life within the first year after the traumatic incident, compared to participants in the TAU-condition.
H7 The CIPE+TAU implementation is more cost-effective compared to the TAU in the short run and may even dominate TAU in the long run (i.e., more effective and less costly).
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)
盲法说明
Investigator: senior statistician will be blinded for condition. Junior statistician will not, due to practical barriers (double role as the study coordinator). The person responsible for randomization will be blinded for the outcome of the screening (T0) and baseline (T1) assessments.
Outcome assessors: graduate psychology students who will perform the clinical interviews will be blinded for condition.
入排标准
- 年龄范围
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receives support from a municipal crisis team
- •Exposure to a traumatic event (as defined by criteria A for the diagnosis of post-traumatic stress disorder (PTSD) in the DSM-5) within the last seven weeks before randomization
- •A total score of 10 or above on the PTSD Symptom Checklist-5 at the time of randomization
- •Age 16 or above
- •Written informed consent
- •Writes and speaks English and/or Norwegian
排除标准
- •Severe psychopathology in need of specialized health care (e.g., psychotic symptoms, or high suicide risk) or substance dependence syndrome in need of specialized health care
- •Known or evident severe cognitive impairment
- •Ongoing traumatization, violence, or threats
- •Unstable dose of psychotropic medication two weeks prior to randomization
- •Concurrent therapy elsewhere before randomization
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5; Norwegian version)
时间窗: Post-treatment (10 - 13 weeks after trauma)
20-item questionnaire that measures DSM-5-specified symptoms of post-traumatic stress disorder (PTSD). The total score ranges from 0 to 80, with higher scores indicating more severe symptoms. Items are rated on a 0 ("not at all") to 4 ("extremely") Likert type scale. The PCL-5 has demonstrated satisfactory psychometric properties in various trauma populations. This study will administer a Norwegian version of the PCL-5. Recall period: one month.
次要结局
- PTSD Checklist for DSM-5 (PCL-5; Norwegian version)(12 months follow-up)
- Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version)(12-months follow-up)
- Patient Health Questionnaire (PHQ-9; Norwegian version)(12-months follow-up)
- Insomnia Severity Index (ISI; Norwegian version)(12-months follow-up)
- Client Satisfaction Questionnaire (CSQ-8; Norwegian version)(Post-treatment (10 - 13 weeks after trauma))
- EQ-5D-5L (Norwegian version)(12-months follow-up)
- The Recovering Quality of Life (ReQoL; Norwegian version)(12-months follow-up)
- Traumatic grief inventory self report, TGI-SR+(12-months follow-up)
- PTSD Checklist for DSM-5 (PCL-5; Norwegian version)(6 months follow-up)
- Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version)(6-months follow-up)
- Patient Health Questionnaire (PHQ-9; Norwegian version)(Post-treatment (10 - 13 weeks after trauma))
- Patient Health Questionnaire (PHQ-9; Norwegian version)(6-months follow-up)
- Insomnia Severity Index (ISI; Norwegian version)(Post-treatment (10 - 13 weeks after trauma))
- Insomnia Severity Index (ISI; Norwegian version)(6-months follow-up)
- EQ-5D-5L (Norwegian version)(Post-treatment (10 - 13 weeks after trauma))
- EQ-5D-5L (Norwegian version)(6-months follow-up)
- The Recovering Quality of Life (ReQoL; Norwegian version)(Post-treatment (10 - 13 weeks after trauma))
- The Recovering Quality of Life (ReQoL; Norwegian version)(6-months follow-up)