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临床试验/NCT06645028
NCT06645028进行中(未招募)不适用

Evaluation of an 8-day Intensive Treatment Programme for PTSD and CPTSD in the Swedish Mental Health Care

Christina Blomdahl2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2021年8月1日最近更新:
适应症

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

  1. 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

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

发起方
Christina Blomdahl
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Christina Blomdahl

R & D Strategic

Vastra Gotaland Region

研究点 (2)

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