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Recruiting NCT04431531

EMDR Pre-treatment Yoga for Complex Trauma

No phase Interventional Trauma, Psychological

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 10 Sessions of yogatherapy associate with EMDR, The second group will have EMDR without yogatherapy.
Who it may be relevant to
Registry conditions: Trauma, Psychological. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • Other 10 Sessions of yogatherapy associate with EMDR
    The first group will have Yogatherapy plus EMDR treatment
  • Other The second group will have EMDR without yogatherapy
    the second one will have EMDR treatment

Primary outcome measures

  • PCL-5: Scale of post-traumatic stress disorder [Time frame: first week]
  • PCL-5: Scale of post-traumatic stress disorder [Time frame: At twenty week]
Secondary outcome measures (3)
  • CAPS-5: PTSD Scale Administered by Clinician [Time frame: First week]
  • CAPS-5: PTSD Scale Administered by Clinician [Time frame: At ten week]
  • CAPS-5: PTSD Scale Administered by Clinician [Time frame: At twenty week]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 2 centers
  • Ch Ville Evrard — Neuilly-sur-Marne
  • Center for Psychotherapy and Psychotraumatology — Saint-Denis

Identifiers

NCT: NCT04431531 · 10477M-YOGA-EMDR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗