Early Support After Exposure to Trauma
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Post-traumatic Stress Disorder
- 发起方
- Norwegian Center for Violence and Traumatic Stress Studies
- 入组人数
- 360
- 试验地点
- 31
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5; Norwegian version)
- 状态
- 招募中
- 最后更新
- 上个月
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).
研究者
入排标准
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)