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Effects of a Qi Gong Program on Dissociative Symptoms in Patients Who Have Experienced Childhood Trauma: a Randomized Controlled Trial (Qi-T) (Qi-T)

Effects of a Qi Gong Program on Dissociative Symptoms in Patients Who Have Experienced Childhood Trauma: a Randomized Controlled Trial

The goal of this clinical trial is to evaluate whether participation in 12 Qi Gong sessions (intervention group), compared with usual care without Qi Gong (control group), reduces dissociative symptoms, as measured by the Dissociative Experience Scale-II (DES-II), between T0 and T1, in outpatients hospitalized for psychiatric disorders related to aversive experiences during childhood.

The main questions it aims to answer are:

- a) To assess whether participation in the Qi Gong program leads to a reduction in symptoms related to complex trauma, b) To assess whether participation in the Qi Gong program leads to an increase in the level of mindfulness c) To explore whether the effect of the Qi Gong program on reducing dissociative symptoms varies according to participants' baseline level of dissociation (Dissociative Experiences Scale-II ) d) To explore whether the effect of the Qi Gong program on reducing dissociative symptoms is sustained over time e) To explore the experiences of patients who participated in the Qi Gong sessions following the intervention.

This is a randomized controlled trial with parallel groups:

  • Intervention group: participation in 12 Qi Gong sessions led by a trained professional, in addition to standard care
  • Control group: standard care, without access to Qi Gong sessions during the study period.

Participants will be required to:

  • complete 3 questionnaires (DES-II, ITQ, MAAS)
  • attend one Qi Gong session per week for 12 weeks (including a group debriefing) or receive standard care at a medical-psychological center (without Qi Gong)
  • complete the same questionnaires (DES-II, ITQ, MAAS) after the 12 weeks
  • complete the DES-II questionnaire 2 months later

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

90

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 18 years of age or older
  • A score above the 10th percentile on the Dissociative Experience Scale-II (DES-II)
  • A score above 2 on the ACE scale (Adverse Childhood Experiences by Felitti et al., 1998)
  • A medical certificate attesting to the participant's fitness to practice Qigong
  • A person enrolled in or receiving benefits from a social security program
  • Free, informed, and written consent signed by the participant and the investigator (no later than the day of enrollment and prior to any examination required by the study).

Exclusion Criteria:

  • In a suicidal crisis
  • In a hallucinatory crisis
  • Experiencing a major depressive episode
  • Unstabilized
  • Pregnant women
  • Those who do not understand French
  • Under guardianship or conservatorship
  • Under judicial protection

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Qi-gong
One Qi Gong session per week for 12 weeks, in groups of six, led by a certified professional.
1 Qi Gong session per week for 12 weeks
无干预:Routine Care (without Qi Gong)
Routine care at a medical-psychological center (appointments with psychologists, doctors, and registered nurses scheduled as part of standard care), excluding participation in Qi Gong sessions

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Reduction in dissociative symptoms
大体时间:3 months after enrollment
Symptoms of dissociation, as measured by the Dissociative Experiences Scale-II (DES-II), will be compared between the intervention group (Qi Gong sessions) and the control group (usual care without Qi Gong).
3 months after enrollment
To assess whether participation in the Qi-Gong program leads to a reduction in symptoms related to complex trauma
大体时间:3 months after enrollment
Change in mean ITQ scores between T1 and T0 (T1-T0); this change will be calculated for each participant.
3 months after enrollment

次要结果测量

结果测量
措施说明
大体时间
To assess whether participation in the Qigong program leads to an increase in the level of mindfulness
大体时间:3 months after enrollement
Change in mean MAAS scores between T1 and T0 (T1-T0); this change will be calculated for each participant.
3 months after enrollement
To investigate whether the effect of the Qigong program on reducing dissociative symptoms varies depending on participants' initial level of dissociation
大体时间:3 months after enrollment
Change in the mean DES-II score between T1 and T0 (T1-T0), according to the baseline level of dissociation, as measured by the DES-II. This change will be calculated for each participant.
3 months after enrollment
To investigate whether the effect of the Qigong program on reducing dissociative symptoms persists over time
大体时间:5 months after enrollement
Change in the mean DES-II score between T2 and T1 (T2 - T1). This change will be calculated for each participant.
5 months after enrollement
To explore the experiences of patients who participated in Qi Gong sessions following the intervention.
大体时间:3 month after enrollment
The experiences of patients who participated in Qi Gong sessions were assessed through focus groups held after each Qi Gong session, in the form of a debriefing,
3 month after enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2029年1月1日

研究完成 (估计的)

2029年3月1日

研究注册日期

首次提交

2026年6月22日

首先提交符合 QC 标准的

2026年6月22日

首次发布 (实际的)

2026年6月26日

研究记录更新

最后更新发布 (实际的)

2026年6月26日

上次提交的符合 QC 标准的更新

2026年6月22日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2025/RUN/0030

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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