Eye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma

NCT ID: NCT04594434

Last Updated: 2022-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-12

Study Completion Date

2022-07-26

Brief Summary

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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

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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.

Conditions

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Complex Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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protocol EMDR + SB / SMP protocol (adjusted)

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

Group Type EXPERIMENTAL

Scale SUD

Intervention Type OTHER

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

VOC scale

Intervention Type OTHER

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

DES II scale

Intervention Type 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).

"recommended" therapy based on EMDR.

Group Type ACTIVE_COMPARATOR

Scale SUD

Intervention Type OTHER

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

VOC scale

Intervention Type OTHER

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

DES II scale

Intervention Type 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.

Interventions

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Scale SUD

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

Intervention Type OTHER

VOC scale

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique d'Yveline

Vieille-Église-en-Yvelines, , France

Site Status

Countries

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France

Other Identifiers

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2020-A01914-35

Identifier Type: -

Identifier Source: org_study_id

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