Eye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma

Complex Post-Traumatic Stress Disorder Clinical Trial

Official title:

Efficiency of the Use of Benevolent Memories in the EMDR Protocol in Complex Psychotrauma (Benevolence Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04594434
• Other study ID #: 2020-A01914-35
• Status: Completed
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: July 26, 2022

Study information

• Verified date: August 2022
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 26, 2022
• Est. primary completion date: July 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complex Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Scale SUD
Subjective Units of Distress Scale ou Subjective Units of Disturbance Scale is a scale of subjective appreciation of emotions
• VOC scale
The VOC (Validity Of Cognition) scale is a scale of value given to cognition.
• DES II scale
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.

Locations

Country	Name	City	State
France	Clinique d'Yveline	Vieille-eglise-en Yvelines

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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.	6 months
Secondary	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;	6 months