NCT05164289

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

December 10, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
Last Updated

September 19, 2024

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

December 6, 2021

Last Update Submit

September 3, 2024

Conditions

Keywords

Schizophrenic disordersPsychosisEye Movement Desensitization and Reprocessing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Assessment of the decrease in the intensity of dissociative symptoms.

    At 6 month after Hospital discharge (M0)

  • Assessment of the decrease in the intensity of anxiety and depressive symptoms.

    At 6 month after Hospital discharge (M0)

  • Quality of life assessment

    At 6 month after Hospital discharge (M0)

Study Arms (2)

Control group

Patients in the control group will have simple consultations on D15, D30, D45, D60 and D75

Other: Control group

EMDR group

Patients in the EMDR group will have EMDR session on D15, D30, D45, D60 and D75

Other: EMDR group

Interventions

Patients in the control group will have simple consultations on D15, D30, D45, D60 and D75

Control group

Patients in the EMDR group will have EMDR session on D15, D30, D45, D60 and D75

EMDR group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ≥ 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

You may not qualify if:

  • \< 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),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Departement of Psychiatry - Hospital René Dubos

Pontoise, 95300, France

Location

Departement of Psychiatry -Hospital Paul Guiraud

Villejuif, 94800, France

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Dr Marie-Claire ASMAR

    Hospital René Dubos - Pontoise

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2021

First Posted

December 20, 2021

Study Start

December 10, 2021

Primary Completion

April 27, 2022

Study Completion

April 27, 2022

Last Updated

September 19, 2024

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations