- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05164289
Interest of EMDR Schizophrenic Disorders (EMDRpsychose)
Interest of EMDR (Eye Movement Desensitization and Reprocessing) Psychotherapy in the Management of Schizophrenic Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Pontoise, France, 95300
- Departement of Psychiatry - Hospital René Dubos
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Villejuif, France, 94800
- Departement of Psychiatry -Hospital Paul Guiraud
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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),
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
Patients in the control group will have simple consultations on D15, D30, D45, D60 and D75
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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
|
Patients in the EMDR group will have EMDR session on D15, D30, D45, D60 and D75
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the decrease in the severity of positive or negative symptoms of schizophrenia
Time Frame: At 6 month after Hospital discharge (M0)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the decrease in the intensity of dissociative symptoms.
Time Frame: At 6 month after Hospital discharge (M0)
|
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)
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Assessment of the decrease in the intensity of anxiety and depressive symptoms.
Time Frame: At 6 month after Hospital discharge (M0)
|
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)
|
Quality of life assessment
Time Frame: At 6 month after Hospital discharge (M0)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr Marie-Claire ASMAR, Hospital René Dubos - Pontoise
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRD 1721
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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