Back to resultsEye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma
Primary Purpose
Complex Post-Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Scale SUD
VOC scale
DES II scale
Sponsored by
About this trial
This is an interventional other trial for Complex Post-Traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- Patient suffering from a combination of a period of complex trauma and a disturbance triggered by situations in adulthood;
- Having signed an informed consent form to participate in the study.
Exclusion Criteria:
- Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- Patient seeking legal benefit from participating in the study;
- Patient previously treated with EMDR;
- Patient unable to understand the information related to the study (linguistic, psychological, cognitive reason, etc.);
- Untreated epileptic patient;
- Patient with severe oculomotor disorders;
- Patient in hypomanic phase;
- Patient treated with high dose corticosteroids;
- Patient with alcohol and / or drug misuse in the 7 days preceding inclusion;
- Pregnant or likely to be (of childbearing age, without effective contraception) or breastfeeding;
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- Patient not beneficiary of a social security scheme.
Sites / Locations
- Clinique d'Yveline
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
protocol EMDR + SB / SMP protocol (adjusted)
protocol EMDR (standard).
Arm Description
Association of a positive memory with the "recommended" therapy based on EMDR.
"recommended" therapy based on EMDR.
Outcomes
Primary Outcome Measures
Effectiveness of the combination of SB and / or PMS with EMDR technique on reducing the disturbance experienced by patients with complex psychotrauma.
Percentage of patients with a 50% reduction in the SUD score(44/5000 measured by the SUD scale ranging from 0 to 10) at the end of the 3rd "active" EMDR session compared to the pre-treatment score of the 1st "active" session
Secondary Outcome Measures
Disturbance felt
The % of patients responding to therapy (with SUD scores = 0 and VOC = 7) at M1, M3 and M6 will be compared between the 2 groups by a Cochran-Mantel-Haenszel test.
Level of dissociation
The change in the level of dissociation by the DES II scale (score from 0 to 100) after therapy will be compared between the 2 groups by an analysis of covariance with adjustment for the score at inclusion;
Full Information
NCT ID
NCT04594434
First Posted
October 13, 2020
Last Updated
August 16, 2022
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT04594434
Brief Title
Eye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma
Official Title
Efficiency of the Use of Benevolent Memories in the EMDR Protocol in Complex Psychotrauma (Benevolence Study)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 12, 2020 (Actual)
Primary Completion Date
July 26, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study wants to demonstrate the effectiveness of combining a positive memory with "recommended" therapy based on EMDR in reducing the disturbance that patients with complex psychotrauma may experience. The positive memory will be called "benevolent memory" (SB) or "less worse memory" (SMP).
Detailed Description
This is an interventional study, prospective, exploratory, comparative, randomized, controlled versus reference treatment protocol, open.
Patients will be seen 16 times for the purposes of the study. They will be hospitalized during therapy. Discharge from hospitalization occurs during follow-up depending on the patient's condition.
They will be evaluated over a period of 4 to 6 weeks between the start (Day 0 = Week 1) and the end of treatment (visit week 12). These visits will coincide with treatment sessions with the EMDR ± SB / SMP protocol, as part of the support of their complex psychotrauma. At the end of treatment, the patient will be evaluated during follow-up visits at Month 1, Month 3 and Month 6.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Post-Traumatic Stress Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
protocol EMDR + SB / SMP protocol (adjusted)
Arm Type
Experimental
Arm Description
Association of a positive memory with the "recommended" therapy based on EMDR.
Arm Title
protocol EMDR (standard).
Arm Type
Active Comparator
Arm Description
"recommended" therapy based on EMDR.
Intervention Type
Other
Intervention Name(s)
Scale SUD
Intervention Description
Subjective Units of Distress Scale ou Subjective Units of Disturbance Scale is a scale of subjective appreciation of emotions
Intervention Type
Other
Intervention Name(s)
VOC scale
Intervention Description
The VOC (Validity Of Cognition) scale is a scale of value given to cognition.
Intervention Type
Other
Intervention Name(s)
DES II scale
Intervention Description
The Dissociative Experiences Scale (DES), which is translated as the Dissociative Experiences Scale, is a self-questionnaire to assess the frequency of various dissociative symptoms in the patient's daily life.
Primary Outcome Measure Information:
Title
Effectiveness of the combination of SB and / or PMS with EMDR technique on reducing the disturbance experienced by patients with complex psychotrauma.
Description
Percentage of patients with a 50% reduction in the SUD score(44/5000 measured by the SUD scale ranging from 0 to 10) at the end of the 3rd "active" EMDR session compared to the pre-treatment score of the 1st "active" session
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Disturbance felt
Description
The % of patients responding to therapy (with SUD scores = 0 and VOC = 7) at M1, M3 and M6 will be compared between the 2 groups by a Cochran-Mantel-Haenszel test.
Time Frame
6 months
Title
Level of dissociation
Description
The change in the level of dissociation by the DES II scale (score from 0 to 100) after therapy will be compared between the 2 groups by an analysis of covariance with adjustment for the score at inclusion;
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient suffering from a combination of a period of complex trauma and a disturbance triggered by situations in adulthood;
Having signed an informed consent form to participate in the study.
Exclusion Criteria:
Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
Patient seeking legal benefit from participating in the study;
Patient previously treated with EMDR;
Patient unable to understand the information related to the study (linguistic, psychological, cognitive reason, etc.);
Untreated epileptic patient;
Patient with severe oculomotor disorders;
Patient in hypomanic phase;
Patient treated with high dose corticosteroids;
Patient with alcohol and / or drug misuse in the 7 days preceding inclusion;
Pregnant or likely to be (of childbearing age, without effective contraception) or breastfeeding;
Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
Patient not beneficiary of a social security scheme.
Facility Information:
Facility Name
Clinique d'Yveline
City
Vieille-eglise-en Yvelines
Country
France
12. IPD Sharing Statement
Learn more about this trial
Eye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma
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