Clinical trial NCT04594434: Eye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma
Official title: Efficiency of the Use of Benevolent Memories in the EMDR Protocol in Complex Psychotrauma (Benevolence Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Post-Traumatic Stress Disorder
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of the combination of SB and / or PMS with EMDR technique on reducing the disturbance experienced by patients with complex psychotrauma.
timeFrame: 6 months
Secondary outcomes:
measure: Disturbance felt
timeFrame: 6 months
measure: Level of dissociation
timeFrame: 6 months
Other outcomes:
Locations:
city: Vieille-eglise-en Yvelines
country: France
facility: Clinique d'Yveline
Study officials:
References: