Eye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma

NCT04594434 | Completed

• 1 other identifier: 2020-A01914-35
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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).

Conditions

Complex Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Disturbance felt

  6 months

• Level of dissociation

  6 months

Study Arms (2)

protocol EMDR + SB / SMP protocol (adjusted)

EXPERIMENTAL

Association of a positive memory with the "recommended" therapy based on EMDR.

Other: Scale SUD; Other: VOC scale; Other: DES II scale

protocol EMDR (standard).

ACTIVE COMPARATOR

"recommended" therapy based on EMDR.

Other: Scale SUD; Other: VOC scale; Other: DES II scale

Interventions

Scale SUD OTHER

Subjective Units of Distress Scale ou Subjective Units of Disturbance Scale is a scale of subjective appreciation of emotions

protocol EMDR (standard).; protocol EMDR + SB / SMP protocol (adjusted)

VOC scale OTHER

The VOC (Validity Of Cognition) scale is a scale of value given to cognition.

protocol EMDR (standard).; protocol EMDR + SB / SMP protocol (adjusted)

DES II scale OTHER

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.

protocol EMDR (standard).; protocol EMDR + SB / SMP protocol (adjusted)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Pregnant or likely to be (of childbearing age, without effective contraception) or breastfeeding;
• Patient not beneficiary of a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique d'Yveline

Vieille-Église-en-Yvelines, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: December 12, 2020
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

FR (1)