跳至主要内容
临床试验/NCT04431531
NCT04431531招募中不适用

EMDR Pre-treatment Yoga for Complex Trauma Randomized Controlled Comparative Study

Dominique JANUEL4 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2016年9月20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
66
试验地点
4
主要终点
PCL-5: Scale of post-traumatic stress disorder

研究概览

简要总结

yoga is a technique of hope. Indeed, it is a practice that specifically combines postures, breathing technique and a state meditative. The combination of these elements produces multiple effects that are exposed to detailed in the publications of Bessel Van der Kolk (Price et al., 2017; Rhodes, Spinazzola, & van der Kolk, 2016; Van der Kolk, 2014; Van Der Kolk et al., 2014) and whose four main effects are summarized here:

  • A regulation of the level of vigilance
  • An improvement in self-awareness
  • An increased sense of self-efficacy
  • Improved metacognition, awareness and regulation emotional

详细描述

Yoga practice has shown benefits in treating multiple physical or mental disorders (Barnes, Bloom, & Nahin, 2008; Khalsa, 2004; Ross, Friedmann, Bevans, & Thomas, 2013) and has recently been evaluated for PTSD. We identified six randomized controlled studies measuring the effect of yoga in women (mostly) who experienced childhood violence (see table). With the exception of one pilot study (Dick, Niles, Street, Dimartino, & Mitchell, 2014; Mitchell et al., 2014), all studies show a significant reduction in PTSD symptoms compared to the pre-treatment period and compared to the control group (waiting list group). In particular, it was shown that this reduction in symptomatology was comparable to that of other commonly practiced psychotherapies, such as the exposure techniques of Behavioural and Cognitive Therapies or EMDR, and comparable to pharmacological treatments (Van Der Kolk et al., 2014). Prolonged yoga therapy would also significantly improve dissociative symptoms (Price et al., 2017). However, all these studies tested the effect of yoga therapy in isolation, without associating it with conventional and recommended treatments for trauma. However, given the fields of action of the yoga listed above, we think that it could be the ideal tool to prepare (in the pre-treatment phase) the work on traumatic memory. We believe that the combination of yoga therapy and EMDR would work in synergy to reduce complex PTSD and achieve a higher success rate than these individual approaches. In this work, we will use a yoga technique adapted to the treatment of psycho-trauma called "trauma sensitive yoga" (Emerson, 2015).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Meets diagnostic criteria for Complex Post-traumatic Stress Disorder according to ICD-11 criteria, related to childhood sexual abuse
  • PCL-5 must be at least 45
  • Age between 18 and
  • Free, informed and signed consent.

排除标准

  • Neurological disorders
  • Pregnant women
  • Severe and/or unstable somatic diseases
  • Diseases resulting in serious motor disorders (e.g. people paralyzed)
  • Patient not affiliated with social security, State Medical Aid (AME)
  • Patient hospitalized under stress in psychiatric care at the decision of the state representative or in psychiatric care at the request of a third party,
  • Patient under guardianship, curatorship and protection of justice
  • Patient participating in parallel biomedical research
  • French language not mastered
  • Persons unable to give consent

研究组 & 干预措施

yogatherapy-EMDR

Active Comparator

one of the two groups will have yogatherapy treatment and Eye movement desensibilization reprocessing (EMDR)

干预措施: 10 Sessions of yogatherapy associate with EMDR (Other)

waiting list and EMDR

Active Comparator

The other group will have Eye movement desensibilization reprocessing

干预措施: The second group will have EMDR without yogatherapy (Other)

结局指标

主要结局

PCL-5: Scale of post-traumatic stress disorder

时间窗: At twenty week

PTSD Scale : Evaluation of clinical symptomatology and severity of PTSD

次要结局

  • CAPS-5: PTSD Scale Administered by Clinician(At twenty week)

研究者

发起方
Dominique JANUEL
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dominique JANUEL

chief of Clinical Center Research

Centre hospitalier de Ville-Evrard, France

研究点 (4)

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