Schizophrenic DisordersEMDRpsychoseNCT05164289
Interest of EMDR Schizophrenic Disorders
An observational study of Schizophrenic Disorders, run by Hôpital NOVO at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenic Disorders
- What is being tested?
- EMDR group
- How many people
- 6 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Dec 2021to 27 Apr 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for decompensated psychotic disorder in the psychiatric departments of the Centers Hospitaliers of Pontoise or Villejuif.
Who may be able to join
- ≥ 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
Who cannot join
- < 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),
Trial locations and contacts
2 sites in 1 country.
France2 sites
Departement of Psychiatry - Hospital René Dubos
Pontoise, 95300
Departement of Psychiatry -Hospital Paul Guiraud
Villejuif, 94800
About this study
Official title: 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.
Read the 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
- Conditions
- Schizophrenic Disorders
- Being tested
- Control group, EMDR group
- Keywords
- Schizophrenic disorders, Psychosis, Eye Movement Desensitization and Reprocessing
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
Patients in the control group will have simple consultations on D15, D30, D45, D60 and D75
EMDR groupOther
Patients in the EMDR group will have EMDR session on D15, D30, D45, D60 and D75
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients in the control group will have simple consultations on D15, D30, D45, D60 and D75 Receives: Other: Control group | |
| EMDR group | Patients in the EMDR group will have EMDR session on D15, D30, D45, D60 and D75 Receives: Other: EMDR group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: At 6 month after Hospital discharge (M0)
Secondary outcomes (3)
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.
Measured: At 6 month after Hospital discharge (M0)
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.
Measured: At 6 month after Hospital discharge (M0)
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
Measured: At 6 month after Hospital discharge (M0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start10 Dec 2021
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Why it stopped: No patients included in the control group and inclusion rate too low.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Marie-Claire ASMAR, Principal investigator, Hospital René Dubos - Pontoise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164289
- Sponsor's protocol ID
- CHRD 1721
- Acronym
- EMDRpsychose
- Status last verified
- May 2022
- First submitted
- 6 Dec 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of EMDR (Eye Movement Desensitization and Reprocessing) Psychotherapy in the Management of Schizophrenic Disorders
- ClinicalTrials.gov ID
- NCT05164289
- Acronym / sponsor ID
- EMDRpsychose / CHRD 1721
- Conditions
- Schizophrenic Disorders
- Keywords
- Schizophrenic disorders, Psychosis, Eye Movement Desensitization and Reprocessing
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No patients included in the control group and inclusion rate too low.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Control groupPatients in the control group will have simple consultations on D15, D30, D45, D60 and D75 |
| EMDR group | – | Other: EMDR groupPatients in the EMDR group will have EMDR session on D15, D30, D45, D60 and D75 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for decompensated psychotic disorder in the psychiatric departments of the Centers Hospitaliers of Pontoise or Villejuif.
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (5 listed)
- < 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupPatients in the control group will have simple consultations on D15, D30, D45, D60 and D75 | Other | Control group |
| EMDR groupPatients in the EMDR group will have EMDR session on D15, D30, D45, D60 and D75 | Other | EMDR group |
Primary outcome
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%.
3 secondary outcomes
Assessment of the decrease in the intensity of dissociative symptoms.
Time frame: 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)
Quality of life assessment
Time frame: At 6 month after Hospital discharge (M0)
Results and safety
The study was stopped early (reason given: No patients included in the control group and inclusion rate too low.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Marie-Claire ASMAR principal investigator
Hospital René Dubos - Pontoise
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenic Disorders, run by Hôpital NOVO at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No patients included in the control group and inclusion rate too low.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the decrease in the severity of positive or negative symptoms of schizophrenia (time frame: At 6 month after Hospital discharge (M0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.