EMDR Pre-treatment Yoga for Complex Trauma

Trauma, Psychological Clinical Trial

— YOGA-EMDR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04431531
• Other study ID #: 10477M-YOGA-EMDR
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2016
• Est. completion date: September 6, 2026

Study information

• Verified date: March 2024
• Source: Centre hospitalier de Ville-Evrard, France
• Contact: Rusheenthira THAVASEELAN, MSC
• Phone: 0143093232
• Email: r.thavaseelan[@]epsve.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: September 6, 2026
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychological Trauma
• Trauma, Psychological
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	Ch Ville Evrard	Neuilly-sur-Marne
France	Center for Psychotherapy and Psychotraumatology	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
Dominique JANUEL

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CGI : Clinical global Impression	Evaluation of overall clinical improvement.	At first week
Other	CGI : Clinical global Impression	Evaluation of overall clinical improvement.	At ten week
Other	CGI : Clinical global Impression	Evaluation of overall clinical improvement.	At twenty week
Primary	PCL-5: Scale of post-traumatic stress disorder	PTSD Scale : Evaluation of clinical symptomatology and severity of PTSD	first week
Primary	PCL-5: Scale of post-traumatic stress disorder	PTSD Scale : Evaluation of clinical symptomatology and severity of PTSD	At twenty week
Secondary	CAPS-5: PTSD Scale Administered by Clinician	Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities	First week
Secondary	CAPS-5: PTSD Scale Administered by Clinician	Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities	At ten week
Secondary	CAPS-5: PTSD Scale Administered by Clinician	Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities	At twenty week