Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT04594434
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2020-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma
Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Organization:
Study Overview
Official Title:
Efficiency of the Use of Benevolent Memories in the EMDR Protocol in Complex Psychotrauma (Benevolence Study)
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: