A Feasibility Study for Written Exposure Therapy for Patients With Post-traumatic Stress Disorder in a Regular Health Care Setting
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
研究概览
简要总结
To investigate if written exposure therapy is feasible for patients with post-traumatic stress disorder
详细描述
A non-inferiority trial in JAMA Psychiatry showed that written exposure therapy (WET) was non-inferior to a gold standard CBT treatment. In comparison to other trauma-focused CBT protocols, WET generally demands less therapist-time, and specifically, less than half compared to CBT that consists of 12 weekly sessions á 60 minutes. The aim of this study is to translate and replicate these results in a Swedish context. This first step is a small feasibility trial which will guide a subsequent large-scale trial.
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
- •Meet criteria for PTSD.
- •If taking psychotropic medication, then the dose must be stable for at least 4 weeks prior to study entry.
- •≥ 18 years
- •Situated in Sweden
- •Be able to express themselves in Swedish, both in verbally and written form.
- •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)
- •Ongoing CBT for trauma
- •Ongoing trauma-related threat (e.g. living with a violent spouse)
结局指标
主要结局
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
时间窗: Time Frame: Baseline, week 5 and follow-up at 6 months
Change in symptoms of post traumatic stress from baseline to post treatment and follow up (6 months). The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. All items are scored on a 0-4 scale. Higher score indicate worse severity
次要结局
- Euroqol, EQ-5D(Time Frame: Baseline, week 5 and follow-up at 6 months)
- Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)(Time Frame: Baseline, week 5 and follow-up at 6 months)
研究者
Erik Andersson
Principal investigator
Karolinska Institutet