Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients

NCT ID: NCT05329363

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-17

Study Completion Date

2027-06-30

Brief Summary

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Schizophrenia affects about 0.7% of the population. Poor insight, which is common in this disease, linked to poor drug compliance is leads to rehospitalisation with major impact on quality of life. Indeed, many patients relapse with exacerbation of symptoms.

Psychoeducation can improve therapeutic alliance and medication compliance.

In this context, an individual psycho-education program (PEPITS) has been developed. PEPITS carried out by nurses during the initial stages of hospitalisation.

The hypothesis is that PEPITS program will decrease relapse and improve the compliance and insight and and so the quality of life.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PEPITS programme

Group Type EXPERIMENTAL

PEPITS Programme

Intervention Type DIAGNOSTIC_TEST

The programme has three main phases:

Phase I: Introduction phase (Session 1) Phase II: Pathology and care work phase (Sessions 2 - 3 - 4) Phase III: Recovery and "stepping stone" phase (Sessions 5 - 6 - 7) The programme provides information, keys and new skills to the patient through 3 phases focusing on pathology and recovery.

Usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Patients will receive the same psychiatric care as the experimental group except of the PEPITS programme.

Interventions

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PEPITS Programme

The programme has three main phases:

Phase I: Introduction phase (Session 1) Phase II: Pathology and care work phase (Sessions 2 - 3 - 4) Phase III: Recovery and "stepping stone" phase (Sessions 5 - 6 - 7) The programme provides information, keys and new skills to the patient through 3 phases focusing on pathology and recovery.

Intervention Type DIAGNOSTIC_TEST

Usual care

Patients will receive the same psychiatric care as the experimental group except of the PEPITS programme.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 65 years
* Patient with a diagnosed and reported schizophrenic disorder announced :

* Schizophrenia
* Schizoaffective disorder
* Or a diagnosed and reported Delusional Disorder
* Express written consent by the participant after receiving information about the study
* Be able to communicate verbally
* Participant affiliated to a social security scheme

Exclusion Criteria

* Pregnant or breastfeeding woman
* Patient who does not speak French
* Participation in a psycho-education group in the last 2 years
* Patient under legal protection or guardianship
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Serrvice de Psychiatrie

Blois, , France

Site Status WITHDRAWN

Service de psychiatrie

Chinon, , France

Site Status RECRUITING

Service de psychiatrie

Dreux, , France

Site Status NOT_YET_RECRUITING

Service de psychiatrie

Fleury-les-Aubrais, , France

Site Status WITHDRAWN

Service de psychiatrie

La Roche-sur-Yon, , France

Site Status RECRUITING

Service de psychiatrie

Neuilly-sur-Marne, , France

Site Status NOT_YET_RECRUITING

Service de psychiatrie

Rennes, , France

Site Status RECRUITING

Service de psychiatrie

Saint-Maurice, , France

Site Status NOT_YET_RECRUITING

Service de psychiatrie

Sainte-Gemmes-sur-Loire, , France

Site Status RECRUITING

Service de psychiatrie

Sotteville-lès-Rouen, , France

Site Status NOT_YET_RECRUITING

Service de psychiatrie

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Arnaud CHESSE

Role: CONTACT

+33(0)2.34.37.89.68

Marie LECLERC

Role: CONTACT

+33(0)2.47.47.46.64

Facility Contacts

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Jessica PÉTÉ SARAROLS

Role: primary

Mathilde JOUIN

Role: primary

Aurélie FLORENTIN

Role: primary

Béatrice SURGET

Role: primary

Damien CROGUENNEC

Role: primary

Efflam BREGEON

Role: primary

Hélène LECUYER

Role: primary

Alex MONDOULET

Role: primary

Other Identifiers

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DR190062

Identifier Type: -

Identifier Source: org_study_id

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