Evaluation of an 8-day Intensive Treatment Programme for PTSD and CPTSD in the Swedish Mental Health Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Post Traumatic Checklist for DSM-5 (PCL-5)
研究概览
简要总结
Post-Traumatic Stress Disorder (PTSD) and Complex PTSD (C-PTSD) are conditions that may develop after a person has been exposed to extremely stressful experiences. The affected individual re-experiences the event despite attempts to avoid reminders of the experience and also experiences heightened tension. In C-PTSD, the individual also experiences significantly impaired ability to regulate emotions, severe negative change in self-image, and difficulty maintaining close relationships.
Traditional trauma-focused psychotherapy for PTSD typically involves one session per week over approximately 6-12 months. Intensive treatment models for both PTSD and C-PTSD have been developed and have shown promising results, with lower dropout rate from treatment compared to traditional treatments. The current project aims to compare the outcomes of an 8-day intensive treatment programme with treatment in a traditional format. Individuals with C-PTSD or PTSD who have not benefited from previous treatment attempts are included in the study. Participants are allocated to the respective treatment group according to principles of person-centered care, where participants are considered competent to make an informed choice of treatment method.
Diagnostic assessment and self-rating of symptoms of PTSD and C-PTSD are conducted before and after treatment, as well as at 3-month follow-up. The study is expected to provide increased knowledge on whether 8-day intensive treatment is a suitable alternative to treatment in a traditional format for PTSD and C-PTSD. The study is also expected to provide important data for considering whether 8-day intensive treatment should be widely implemented in Swedish psychiatry.
详细描述
- Study aims and research questions
The purpose of the study is to compare the outcomes and potential risks between two treatment methods for treatment-resistant PTSD and C-PTSD: 8-day intensive treatment and conventional treatment. Additionally, the study aims to investigate whether there are individual factors that influence the outcomes of each treatment format.
Specific research questions:
• Can a difference in the severity of PTSD and C-PTSD be observed after 8-day intensive treatment? Does the outcome differ compared to conventional treatment for PTSD and C-PTSD?
• Are there individual factors that influence the treatment outcome? Does the impact of these factors differ between the study groups?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •CPTSD according to ICD-11
- •PTSD with at least one comorbid disorder requiring psychiatric outpatient treatment
- •PTSD with previous unsuccessful trauma-focused treatment
排除标准
- •ongoing substance or alcohol abuse
- •use of benzodiazepines
- •acute suicidality
- •dissociative identity disorder (DID)
- •insufficient knowledge of the Swedish language to complete questionnaires
结局指标
主要结局
Post Traumatic Checklist for DSM-5 (PCL-5)
时间窗: Pre-treatment: 2 weeks before start. Posttreatment: 1 week after treatment. Follow-up: 3 months after treatment. Repeated measure at session 2,4,6,8,10,12,14. In ITP this corresponds to day 1-7 of treatment. TAU this corresponds to week 2-14 of treatm.
Self-report measure of PTSD symptoms according to DSM-5 criteria. PCL-5 contains 20 items, rated on a 5-point scale (0 = "not at all" to 4 ("extremely"). It has shown good internal reliability (.96) and test-retest reliability (.84) (Bovin et al., 2016). PCL-5 has also demonstrated sensitivity to clinical change during treatment (Marx et al., 2022)
次要结局
- International Trauma Questionnaire (ITQ)(Pre-treatment: 2 weeks before start. Posttreatment: 1 week after treatment. Follow-up: 3 months after treatment.)
研究者
Christina Blomdahl
R & D Strategic
Vastra Gotaland Region
