Schizophrenic Disorders Clinical Trial
— EMDRpsychoseOfficial title:
Interest of EMDR (Eye Movement Desensitization and Reprocessing) Psychotherapy in the Management of Schizophrenic Disorders
NCT number | NCT05164289 |
Other study ID # | CHRD 1721 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | December 10, 2021 |
Est. completion date | April 27, 2022 |
Verified date | May 2022 |
Source | Centre Hospitalier René Dubos |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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), |
Country | Name | City | State |
---|---|---|---|
France | Departement of Psychiatry - Hospital René Dubos | Pontoise | |
France | Departement of Psychiatry -Hospital Paul Guiraud | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier René Dubos |
France,
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) |
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