EMDR Pre-treatment Yoga for Complex Trauma (YOGA-EMDR)
Primary Purpose
Trauma, Psychological
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
10 Sessions of yogatherapy associate with EMDR
The second group will have EMDR without yogatherapy
Sponsored by
About this trial
This is an interventional other trial for Trauma, Psychological focused on measuring Yogatherapy-EMDR-psychiatry
Eligibility Criteria
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
Sites / Locations
- Ch Ville Evrard
- Center for Psychotherapy and Psychotraumatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
yogatherapy-EMDR
waiting list and EMDR
Arm Description
one of the two groups will have yogatherapy treatment and Eye movement desensibilization reprocessing (EMDR)
The other group will have Eye movement desensibilization reprocessing
Outcomes
Primary Outcome Measures
PCL-5
Scale of post-traumatic stress disorder
PCL-5
Scale of post-traumatic stress disorder
Secondary Outcome Measures
CAPS-5
PTSD Scale Administered by Clinician
CAPS-5
PTSD Scale Administered by Clinician
CAPS-5
PTSD Scale Administered by Clinician
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04431531
Brief Title
EMDR Pre-treatment Yoga for Complex Trauma
Acronym
YOGA-EMDR
Official Title
EMDR Pre-treatment Yoga for Complex Trauma Randomized Controlled Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
May 29, 2022 (Anticipated)
Study Completion Date
May 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Januel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Psychological
Keywords
Yogatherapy-EMDR-psychiatry
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
the first group is about EMDR treatment. The second group is about YOGATHERAPY
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
yogatherapy-EMDR
Arm Type
Active Comparator
Arm Description
one of the two groups will have yogatherapy treatment and Eye movement desensibilization reprocessing (EMDR)
Arm Title
waiting list and EMDR
Arm Type
Active Comparator
Arm Description
The other group will have Eye movement desensibilization reprocessing
Intervention Type
Other
Intervention Name(s)
10 Sessions of yogatherapy associate with EMDR
Other Intervention Name(s)
The second group will have EMDR without yogatherapy
Intervention Description
The first group will have Yogatherapy plus EMDR treatment
Intervention Type
Other
Intervention Name(s)
The second group will have EMDR without yogatherapy
Intervention Description
the second one will have EMDR treatment
Primary Outcome Measure Information:
Title
PCL-5
Description
Scale of post-traumatic stress disorder
Time Frame
FIRST WEEK
Title
PCL-5
Description
Scale of post-traumatic stress disorder
Time Frame
AT TWENTY WEEK
Secondary Outcome Measure Information:
Title
CAPS-5
Description
PTSD Scale Administered by Clinician
Time Frame
FIRST WEEK
Title
CAPS-5
Description
PTSD Scale Administered by Clinician
Time Frame
AT TEN WEEK
Title
CAPS-5
Description
PTSD Scale Administered by Clinician
Time Frame
AT TWENTY WEEK
Other Pre-specified Outcome Measures:
Title
CGI
Description
Overall Clinical Print Scale
Time Frame
AT FIRST WEEK
Title
CGI
Description
Overall Clinical Print Scale
Time Frame
AT TEN WEEK
Title
CGI
Description
Overall Clinical Print Scale
Time Frame
AT TWENTY WEEK
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female can participate to this study
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ch Ville Evrard
City
Neuilly-sur-Marne
ZIP/Postal Code
93330
Country
France
Facility Name
Center for Psychotherapy and Psychotraumatology
City
Saint-Denis
ZIP/Postal Code
93200
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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EMDR Pre-treatment Yoga for Complex Trauma
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