Effects of a Qi Gong Program on Dissociative Symptoms in Patients Who Have Experienced Childhood Trauma: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Reduction in dissociative symptoms
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •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).
排除标准
- •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
结局指标
主要结局
Reduction in dissociative symptoms
时间窗: 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).
To assess whether participation in the Qi-Gong program leads to a reduction in symptoms related to complex trauma
时间窗: 3 months after enrollment
Change in mean ITQ scores between T1 and T0 (T1-T0); this change will be calculated for each participant.
次要结局
- To assess whether participation in the Qigong program leads to an increase in the level of mindfulness(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(3 months after enrollment)
- To investigate whether the effect of the Qigong program on reducing dissociative symptoms persists over time(5 months after enrollement)
- To explore the experiences of patients who participated in Qi Gong sessions following the intervention.(3 month after enrollment)