NCT04431531

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Sep 2016Sep 2026

Study Start

First participant enrolled

September 20, 2016

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2026

Expected
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

8 years

First QC Date

June 11, 2020

Last Update Submit

March 3, 2024

Conditions

Trauma, Psychological

Keywords

Yogatherapy-EMDR-psychiatry

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • CAPS-5: PTSD Scale Administered by Clinician

    First week

  • CAPS-5: PTSD Scale Administered by Clinician

    At ten week

  • CAPS-5: PTSD Scale Administered by Clinician

    At twenty week

Other Outcomes (3)

  • CGI : Clinical global Impression

    At first week

  • CGI : Clinical global Impression

    At ten week

  • CGI : Clinical global Impression

    At twenty week

Study Arms (2)

yogatherapy-EMDR

ACTIVE COMPARATOR

one of the two groups will have yogatherapy treatment and Eye movement desensibilization reprocessing (EMDR)

Other: 10 Sessions of yogatherapy associate with EMDR

waiting list and EMDR

ACTIVE COMPARATOR

The other group will have Eye movement desensibilization reprocessing

Other: The second group will have EMDR without yogatherapy

Interventions

10 Sessions of yogatherapy associate with EMDROTHER

The first group will have Yogatherapy plus EMDR treatment

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

the second one will have EMDR treatment

waiting list and EMDR

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female can participate to this study
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ch Ville Evrard

Neuilly-sur-Marne, 93330, France

RECRUITING

Center for Psychotherapy and Psychotraumatology

Saint-Denis, 93200, France

RECRUITING

MeSH Terms

Conditions

Psychological Trauma

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Rusheenthira THAVASEELAN, MSC

CONTACT

0143093232r.thavaseelan@epsve.fr

Youcef BENCHERIF, MSC

CONTACT

0143093232y.bencherif@epsve.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: the first group is about EMDR treatment. The second group is about YOGATHERAPY
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
chief of Clinical Center Research

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 16, 2020

Study Start

September 20, 2016

Primary Completion

September 30, 2024

Study Completion (Estimated)

September 6, 2026

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

FR(2)