Clinical trial NCT05329363: Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients
Official title: Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients: A Randomized, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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

Primary outcomes:
measure: Evolution of insight
timeFrame: From inclusion (T0) up to one year (T12) after randomisation
Secondary outcomes:
measure: Evolution of patient's quality of life
timeFrame: From inclusion (T0) up to one year (T12) after randomisation
measure: Medication compliance
timeFrame: From inclusion (T0) up to one year (T12) after randomisation
measure: Evolution of quality of life at work
timeFrame: From prior to their training in the programme up to 6 months after their first inclusion
measure: Evolution of psychological well-being at work
timeFrame: From prior to their training in the programme up to 6 months after their first inclusion
measure: Evolution of job satisfaction
timeFrame: From prior to their training in the programme up to 6 months after their first inclusion
measure: Evolution of sense of self-efficacy
timeFrame: From prior to their training in the programme up to 6 months after their first inclusion
measure: Evolution of commitment to work
timeFrame: From prior to their training in the programme up to 6 months after their first inclusion
Other outcomes:
Locations:
city: Blois
country: France
facility: Serrvice de Psychiatrie
city: Chinon
country: France
facility: Service de psychiatrie
city: Dreux
country: France
facility: Service de psychiatrie
city: Fleury-les-Aubrais
country: France
facility: Service de psychiatrie
city: La Roche sur Yon
country: France
facility: Service de psychiatrie
city: Neuilly-sur-Marne
country: France
facility: Service de psychiatrie
city: Rennes
country: France
facility: Service de psychiatrie
city: Saint-Maurice
country: France
facility: Service de psychiatrie
city: Sainte-Gemmes-sur-Loire
country: France
facility: Service de psychiatrie
city: Sotteville-lès-Rouen
country: France
facility: Service de psychiatrie
city: Tours
country: France
facility: Service de psychiatrie
Study officials:
References: