Eye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma

Not Applicable

Completed

• Conditions: Complex Post-Traumatic Stress Disorder
• Interventions: Other: Scale SUD; Other: VOC scale; Other: DES II scale

• Registration Number: NCT04594434
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Study Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-20
• Study Start: 2020-12-12
• Primary Completion: 2022-07-26
• Study Completion: 2022-07-26
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
protocol EMDR (standard).	VOC scale	"recommended" therapy based on EMDR.
protocol EMDR + SB / SMP protocol (adjusted)	DES II scale	Association of a positive memory with the "recommended" therapy based on EMDR.
protocol EMDR + SB / SMP protocol (adjusted)	Scale SUD	Association of a positive memory with the "recommended" therapy based on EMDR.
protocol EMDR (standard).	Scale SUD	"recommended" therapy based on EMDR.
protocol EMDR + SB / SMP protocol (adjusted)	VOC scale	Association of a positive memory with the "recommended" therapy based on EMDR.
protocol EMDR (standard).	DES II scale	"recommended" therapy based on EMDR.

Primary Outcome Measures

Name	Time	Method
Effectiveness of the combination of SB and / or PMS with EMDR technique on reducing the disturbance experienced by patients with complex psychotrauma.	6 months	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

Name	Time	Method
Disturbance felt	6 months	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	6 months	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;

Trial Locations

Locations (1)

Clinique d'Yveline; 🇫🇷 Vieille-eglise-en Yvelines, France