EMDR Pre-treatment Yoga for Complex Trauma (YOGA-EMDR)

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

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

Study Overview

• Status: Recruiting
• Conditions: Trauma, Psychological
• Intervention / Treatment: Other: 10 Sessions of yogatherapy associate with EMDR; Other: The second group will have EMDR without yogatherapy

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).

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rusheenthira THAVASEELAN, Msc; Phone Number: 0143093232; Email: r.thavaseelan@epsve.fr
• Study Contact Backup: Name: Youcef BENCHERIF, MSC; Phone Number: 0143093232; Email: y.bencherif@epsve.fr

Study Locations

• France
  • Neuilly-sur-Marne, France, 93330
    • Recruiting
    • Ch Ville Evrard
    • Contact: Florence Durand, MSC; Email: f.durand@epsve.fr
    • Principal Investigator: Dominique Januel, MBBS
  • Saint-Denis, France, 93200
    • Recruiting
    • Center for Psychotherapy and Psychotraumatology
    • Contact: camille ALLENE, MSC; Email: c.allene@epsve.fr
    • Principal Investigator: khalid KALALOU, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: yogatherapy-EMDR; one of the two groups will have yogatherapy treatment and Eye movement desensibilization reprocessing (EMDR)	Other: 10 Sessions of yogatherapy associate with EMDR; The first group will have Yogatherapy plus EMDR treatment; Other Names: The second group will have EMDR without yogatherapy
Active Comparator: waiting list and EMDR; The other group will have Eye movement desensibilization reprocessing	Other: The second group will have EMDR without yogatherapy; the second one will have EMDR treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCL-5: Scale of post-traumatic stress disorder	PTSD Scale : Evaluation of clinical symptomatology and severity of PTSD	first week
PCL-5: Scale of post-traumatic stress disorder	PTSD Scale : Evaluation of clinical symptomatology and severity of PTSD	At twenty week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAPS-5: PTSD Scale Administered by Clinician	Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities	First week
CAPS-5: PTSD Scale Administered by Clinician	Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities	At ten week
CAPS-5: PTSD Scale Administered by Clinician	Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities	At twenty week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGI : Clinical global Impression	Evaluation of overall clinical improvement.	At first week
CGI : Clinical global Impression	Evaluation of overall clinical improvement.	At ten week
CGI : Clinical global Impression	Evaluation of overall clinical improvement.	At twenty week

Collaborators and Investigators

• Sponsor: Dominique JANUEL

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2016
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 6, 2026

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Yogatherapy-EMDR-psychiatry
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Wounds and Injuries; Psychological Trauma
• Other Study ID Numbers: 10477M-YOGA-EMDR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No