Interest of EMDR Schizophrenic Disorders (EMDRpsychose)

May 4, 2022 updated by: Centre Hospitalier René Dubos

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

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.

Study Overview

Status

Terminated

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

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pontoise, France, 95300
        • Departement of Psychiatry - Hospital René Dubos
      • Villejuif, France, 94800
        • Departement of Psychiatry -Hospital Paul Guiraud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized for decompensated psychotic disorder in the psychiatric departments of the Centers Hospitaliers of Pontoise or Villejuif.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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)
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dr Marie-Claire ASMAR, Hospital René Dubos - Pontoise

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 10, 2021

Primary Completion (ACTUAL)

April 27, 2022

Study Completion (ACTUAL)

April 27, 2022

Study Registration Dates

First Submitted

December 6, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (ACTUAL)

December 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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