Internet Delivered Condensed Cognitive Behavioral Treatment (Prolonged Exposure) for Individuals Treated Within Somatic Trauma Care.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
研究概览
简要总结
The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment.
详细描述
The study is un-controlled with 250 participants that will undergo a brief trauma-focused Internet-based CBT treatment, delivered as a three-week treatment comprising of four modules (psychoeducation/rational, in vivo exposure, imaginal exposure and relapse prevention). The primary outcome is the PCL-5. Secondary outcomes are level of depression (PHQ-9), quality of life (WSAS) and predictors, moderators and mediators of clinically meaningful change in symptoms, dropout rate, rates of inclusion, attrition, adherence,and negative effects.
Self-reported, qualitative data from participants will be gathered at treatment completion to capture participants' experiences of participating in the intervention, as well as their views on how to further improve the intervention. The treatment effects will be evaluated using a within-group design with repeated measurements. Participants in the study will be will recruited from patients treated in the somatic trauma care at the Karolinska University Hospital in Stockholm, 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exposed to trauma in the past two months according to criterion A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence).
- •PCL-5 total sum score>10
- •≥ 18 years
- •Situated in Sweden
- •Signed informed consent
排除标准
- •Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the MINI)
- •Unable to read and write in Swedish
- •Receiving other psychological trauma-focused treatment
- •Ongoing trauma-related threat (e.g., living with a violent spouse)
- •Not stable dose of antidepressant medication the last two weeks
结局指标
主要结局
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
时间窗: week -3, -2 and -1 before treatment start, immediately before start of treatment, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month and 6 months follow up.
The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
次要结局
- Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)(week -3 before treatment start, immediately before start of treatment, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month and 6 months follow up.)
- Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress.(week -3 before treatment start, immediately before start of treatment, , weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month and 6 months follow up.)
研究者
Maria Bragesjo
PhD, Licensed Psychologist
Karolinska Institutet