Clinical trial NCT04431531: EMDR Pre-treatment Yoga for Complex Trauma
Official title: EMDR Pre-treatment Yoga for Complex Trauma Randomized Controlled Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trauma, Psychological
Keywords: Yogatherapy-EMDR-psychiatry
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the first group is about EMDR treatment. The second group is about YOGATHERAPY
Primary purpose: OTHER

Brief summary: 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

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

. Women

* 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 70.
* Free, informed and signed consent.

Exclusion Criteria:

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

Primary outcomes:
measure: PCL-5: Scale of post-traumatic stress disorder
timeFrame: first week
measure: PCL-5: Scale of post-traumatic stress disorder
timeFrame: At twenty week
Secondary outcomes:
measure: CAPS-5: PTSD Scale Administered by Clinician
timeFrame: First week
measure: CAPS-5: PTSD Scale Administered by Clinician
timeFrame: At ten week
measure: CAPS-5: PTSD Scale Administered by Clinician
timeFrame: At twenty week
Other outcomes:
measure: CGI : Clinical global Impression
timeFrame: At first week
measure: CGI : Clinical global Impression
timeFrame: At ten week
measure: CGI : Clinical global Impression
timeFrame: At twenty week
Locations:
city: Neuilly-sur-Marne
country: France
facility: Ch Ville Evrard
city: Saint-Denis
country: France
facility: Center for Psychotherapy and Psychotraumatology
Study officials:
References: