跳至主要内容
临床试验/NCT06535243
NCT06535243招募中不适用

Evaluation of the Efficacy of "Lifespan Integration" Therapy in Patients With Complex Post-Traumatic Stress Disorder

Centre Hospitalier St Anne1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
38
试验地点
1
主要终点
change of the scores of International Trauma Questionnaire

研究概览

简要总结

The study aims to evaluate the efficacy of a relatively new type of psychotherapy called Lifespan Integration (LI) in patients suffering of complex PTSD

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • •patients diagnosed with complex PTSD
  • •French speaking
  • •first time following an LI type of therapy
  • •psychotropic treatment is allowed

排除标准

  • •no other parallel psychotherapy is accepted (if the patient underwent recently any other type of psychotherapy, a "wash out " period of minimum 4 weeks is required )
  • •no active manic episode at the time of inclusion
  • •no active psychotic episode at the time of inclusion
  • •no chronic psychotic disorder diagnosis
  • •no autistic spectrum disorder diagnosis ,
  • •no intellectual deficit

研究组 & 干预措施

LI Therapy

Experimental

LI Therapy will be delivered in two recruiting centers by experienced LI Therapy trained psychologists or psychiatrists (a minimum level three of training is required) The intervention will consist in delivering 15 "Basic" Protocol therapy sessions targeting symptoms of complex PTSD The study contains one single arm. One extra-session called PTSD protocol could be optionally delivered if the patient had a very recent trauma that could exacerbate his PTSD symptoms. This session is delivered in the beginning of the research protocol.

干预措施: Lifespan Integration Therapy (LI) (Behavioral)

结局指标

主要结局

change of the scores of International Trauma Questionnaire

时间窗: maximum one year

International Trauma Questionnaire measures subscores of simple and complex PTSD, the score is calculated using an algorithm, a minimum score of 8 for the PTSD simple part and of 8 for PTSD complex part is needed in order to diagnose a complex PTSD; the maximum score for simple PTSD is 16, same for complex PTSD.

次要结局

  • Difficulties in Emotion Regulation Scale (DERS) Score(maximum one year)

研究者

发起方
Centre Hospitalier St Anne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandru GAMAN

Medic Doctor MD

Centre Hospitalier St Anne

研究点 (1)

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