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Eye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma

G

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Completed

Conditions

Complex Post-Traumatic Stress Disorder

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04594434
2020-A01914-35

Details and patient eligibility

About

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).

Full 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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 2 patient groups

protocol EMDR + SB / SMP protocol (adjusted)
Experimental group
Description:
Association of a positive memory with the "recommended" therapy based on EMDR.
Treatment:
Other: VOC scale
Other: Scale SUD
Other: DES II scale
protocol EMDR (standard).
Active Comparator group
Description:
"recommended" therapy based on EMDR.
Treatment:
Other: VOC scale
Other: Scale SUD
Other: DES II scale

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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