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Recruiting NCT05329363

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

No phase Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PEPITS Programme, Usual care.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients: A Randomized, Multicenter Trial

Overview

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.

Interventions

  • Diagnostic test 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.
  • Other Usual care
    Patients will receive the same psychiatric care as the experimental group except of the PEPITS programme.

Primary outcome measures

  • Evolution of insight [Time frame: From inclusion (T0) up to one year (T12) after randomisation]
Secondary outcome measures (7)
  • Evolution of patient's quality of life [Time frame: From inclusion (T0) up to one year (T12) after randomisation]
  • Medication compliance [Time frame: From inclusion (T0) up to one year (T12) after randomisation]
  • Evolution of quality of life at work [Time frame: From prior to their training in the programme up to 6 months after their first inclusion]
  • Evolution of psychological well-being at work [Time frame: From prior to their training in the programme up to 6 months after their first inclusion]
  • Evolution of job satisfaction [Time frame: From prior to their training in the programme up to 6 months after their first inclusion]
  • Evolution of sense of self-efficacy [Time frame: From prior to their training in the programme up to 6 months after their first inclusion]
  • Evolution of commitment to work [Time frame: From prior to their training in the programme up to 6 months after their first inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 11 centers
  • Serrvice de Psychiatrie — Blois
  • Service de psychiatrie — Chinon
  • Service de psychiatrie — Dreux
  • Service de psychiatrie — Fleury-les-Aubrais
  • Service de psychiatrie — La Roche-sur-Yon
  • Service de psychiatrie — Neuilly-sur-Marne
  • Service de psychiatrie — Rennes
  • Service de psychiatrie — Saint-Maurice
  • … and 3 more centers

Identifiers

NCT: NCT05329363 · DR190062

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗