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NCT Number: NCT04431531

EMDR Pre-treatment Yoga for Complex Trauma

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

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ch Ville Evrard, Neuilly-sur-Marne, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10 Sessions of yogatherapy associate with EMDR

Other

The first group will have Yogatherapy plus EMDR treatment

Other names: The second group will have EMDR without yogatherapy

The second group will have EMDR without yogatherapy

Other

the second one will have EMDR treatment

Primary outcomes

  1. PCL-5: Scale of post-traumatic stress disorder

    Time frame: first week

    PTSD Scale :

    Evaluation of clinical symptomatology and severity of PTSD

  2. PCL-5: Scale of post-traumatic stress disorder

    Time frame: At twenty week

    PTSD Scale :

    Evaluation of clinical symptomatology and severity of PTSD

Secondary outcomes

  1. CAPS-5: PTSD Scale Administered by Clinician

    Time frame: First week

    Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities

  2. CAPS-5: PTSD Scale Administered by Clinician

    Time frame: At ten week

    Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities

  3. CAPS-5: PTSD Scale Administered by Clinician

    Time frame: At twenty week

    Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities

Other outcomes

  1. CGI : Clinical global Impression

    Time frame: At first week

    Evaluation of overall clinical improvement.

  2. CGI : Clinical global Impression

    Time frame: At ten week

    Evaluation of overall clinical improvement.

  3. CGI : Clinical global Impression

    Time frame: At twenty week

    Evaluation of overall clinical improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Rusheenthira THAVASEELAN, MSC

CONTACT

[email protected]

0143093232

Youcef BENCHERIF, MSC

CONTACT

[email protected]

0143093232

Sponsors and collaborators

Lead sponsor

Dominique JANUEL

Other

Registry information

Official study title

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

Acronym: YOGA-EMDR

Important dates

Study start
2016
Primary completion
2024
Study completion
2026
First posted
Jun 16, 2020
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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