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Completed

NCT Number: NCT04594434

Eye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique d'Yveline

Vieille-Église-en-Yvelines, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scale SUD

Other

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

VOC scale

Other

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

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.

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.

    Time frame: 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 outcomes

  1. Disturbance felt

    Time frame: 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.

  2. Level of dissociation

    Time frame: 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;

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 20, 2020
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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