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RecruitingNCT04431531YOGA-EMDRUpdated Mar 6, 2024

EMDR Pre-treatment Yoga for Complex Trauma

An interventional study of 10 Sessions of yogatherapy associate with EMDR and The second group will have EMDR without yogatherapy in Trauma, Psychological, sponsored by Dominique JANUEL. Recruiting at 2 sites in France. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Dominique JANUEL · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as recruiting.
  • Registered 3 years 8 months after the study started (first participant enrolled Sep 2016, registered Jun 2020).
  • Started Sep 2016; still recruiting 10 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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
Read the 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).

02

Conditions studied

  • Trauma, Psychological

Keywords

  • Yogatherapy-EMDR-psychiatry
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's planned enrollment of 66 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Dominique JANUEL is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • 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

  • Active comparator
    waiting list and EMDR

    The other group will have Eye movement desensibilization reprocessing

    Other: The second group will have EMDR without yogatherapy

Interventions

  • Other10 Sessions of yogatherapy associate with EMDR

    The first group will have Yogatherapy plus EMDR treatment

    Also known as: The second group will have EMDR without yogatherapy

  • OtherThe second group will have EMDR without yogatherapy

    the second one will have EMDR treatment

06

What researchers measure

Primary outcomes

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

    PTSD Scale : Evaluation of clinical symptomatology and severity of PTSD

    Time frame: first week

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

    PTSD Scale : Evaluation of clinical symptomatology and severity of PTSD

    Time frame: At twenty week

Secondary outcomes

  1. CAPS-5: PTSD Scale Administered by Clinician

    Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities

    Time frame: First week

  2. CAPS-5: PTSD Scale Administered by Clinician

    Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities

    Time frame: At ten week

  3. CAPS-5: PTSD Scale Administered by Clinician

    Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities

    Time frame: At twenty week

Other outcomes

  1. CGI : Clinical global Impression

    Evaluation of overall clinical improvement.

    Time frame: At first week

  2. CGI : Clinical global Impression

    Evaluation of overall clinical improvement.

    Time frame: At ten week

  3. CGI : Clinical global Impression

    Evaluation of overall clinical improvement.

    Time frame: At twenty week

07

Study locations

2 of 2 sites recruiting
  • Ch Ville Evrard
    Neuilly-sur-Marne, 93330, France
    • Florence Durand, MSC · Contact · f.durand@epsve.fr
    • Dominique Januel, MBBS · Principal investigator
    Recruiting
  • Center for Psychotherapy and Psychotraumatology
    Saint-Denis, 93200, France
    • camille ALLENE, MSC · Contact · c.allene@epsve.fr
    • khalid KALALOU, MBBS · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04431531
Lead sponsor
Dominique JANUEL
Responsible party
Dominique JANUEL (chief of Clinical Center Research, Centre hospitalier de Ville-Evrard, France) — Sponsor-investigator
First posted
Jun 16, 2020
Start date
Sep 20, 2016
Primary completion
Sep 30, 2024 (estimated)
Completion
Sep 6, 2026 (estimated)
Last update
Mar 6, 2024

Study contacts

Rusheenthira THAVASEELAN, MSC
Contact
r.thavaseelan@epsve.fr
0143093232
Youcef BENCHERIF, MSC
Contact
y.bencherif@epsve.fr
0143093232

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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