Interest of EMDR Schizophrenic Disorders

Schizophrenic Disorders Clinical Trial

— EMDRpsychose  

Official title:

Interest of EMDR (Eye Movement Desensitization and Reprocessing) Psychotherapy in the Management of Schizophrenic Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05164289
• Other study ID #: CHRD 1721
• Status: Terminated
• Start date: December 10, 2021
• Est. completion date: April 27, 2022

Study information

• Verified date: May 2022
• Source: Centre Hospitalier René Dubos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to determine the interest of the use of EMDR (Eye Movement Desensitization and Reprocessing) psychotherapy in the management of psychotic disorders, in particular schizophrenic disorders.

Description:

Since 2015 more and more studies conducted by researchers, especially Dutch and English, are interested in the use of EMDR (Eye Movement Desensitization and Reprocessing) for other pathologies such as bipolar disorder, unipolar depression, anxiety disorders, psychotic disorders, substance use disorders and chronic pain. These studies show that EMDR appears to be a technique that is both effective, capable of significantly improving symptoms, and without risk for patients, while respecting the protocol and the clinical stabilization provided during the procedure. To date, the use of EMDR for the management of psychotic patients has not been the subject of any prospective study in France and the authors' conclusions converge on the fact that it is essential to carry out more research on the subject. For this, the investigators wish to evaluate the effect of EMDR on the management of patients with schizophrenic disorders, on the basis that this psychotherapy would improve their quality of life (improvement of all the specific scores used in psychiatry). : PANSS, DES, HAD and WEMWBS scales). Finally, the investigators believe that it is relevant to assess the benefit of EMDR six months after hospitalization of patients, in order to measure the maintenance of this efficacy in the medium term

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years and over,
• Hospitalized for decompensated psychotic disorder, Positive diagnosis of schizophrenia or schizoaffective disorder (according to the DSM-V psychiatry manual),
• With positive or negative symptoms according to the Positive and Negative Syndrome Scale (PANSS),
• Stabilized clinical condition (considered compatible with hospital discharge),
• With ambulatory follow-up planned after hospitalization

Exclusion Criteria:

• < 18 years,
• Patients who do not meet the diagnostic criteria (according to the DSM-V psychiatry manual) for schizophrenic or schizoaffective disorder),
• Non-French speaking or illiterate patients,
• Cognitive disorders making it impossible the understanding and the none- opposition to the study,
• Non-stabilized clinical condition (incompatible with hospital discharge),

Related Conditions & MeSH terms

• Disease
• Schizophrenia
• Schizophrenic Disorders

Intervention

Other:
• Control group
Patients in the control group will have simple consultations on D15, D30, D45, D60 and D75
• EMDR group
Patients in the EMDR group will have EMDR session on D15, D30, D45, D60 and D75

Locations

Country	Name	City	State
France	Departement of Psychiatry - Hospital René Dubos	Pontoise
France	Departement of Psychiatry -Hospital Paul Guiraud	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier René Dubos

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the decrease in the severity of positive or negative symptoms of schizophrenia	The decrease in the severity of positive or negative symptoms of schizophrenia is assessed using the "Positive and Negative Syndrome Scale" (PANSS) between M0 and M6.This decrease will be considered effective if it's greater than or equal to 20%.	At 6 month after Hospital discharge (M0)
Secondary	Assessment of the decrease in the intensity of dissociative symptoms.	The decrease in the intensity of dissociative symptoms is assessed using the Dissociative Experience Scale (DES) between M0 and M6.; The DES is a short written questionnaire. It consists of 28 items that assess the frequency of various dissociative symptoms in the patient's daily life.; 0 corresponds to the answer "Never" and 100 to the answer "All the time". The total score is obtained by adding the scores of the 28 items and then dividing by 28. This gives a score between 0 and 100.	At 6 month after Hospital discharge (M0)
Secondary	Assessment of the decrease in the intensity of anxiety and depressive symptoms.	The decrease in the intensity of anxiety and depressive symptoms is assessed using the Hospital Anxiety and Depression (HAD) between M0 and M6 The HAD scale is a short written questionnaire, consisting of 14 items to assess the patient's symptoms of anxiety and depression.; The total anxiety score is obtained by adding the scores of items 1, 3, 5, 7, 9, 11 and 13 and the total depression score by adding the scores of the remaining items.; The interpretation of the results is as follows: Score = 7 = absence of symptomatology, 8 = Score = 10 = questionable symptomatology Score = 11 = certain symptomatology.	At 6 month after Hospital discharge (M0)
Secondary	Quality of life assessment	The quality of life is assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).; The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) assesses the psychological well-being of individuals. It consists of 14 items on a likert scale of 5 (1: never, 2: rarely, 3: sometimes, 4: often, 5: all the time).; In this scale, there is no threshold score, but the higher the score, the stronger the psychological well-being of the individual.; An improvement in the quality of life is measured by an increase in the scale score between M0 and M6	At 6 month after Hospital discharge (M0)