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

Schizophrenia Clinical Trial

— PEPITS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05329363
• Other study ID #: DR190062
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: June 2027

Study information

• Verified date: April 2024
• Source: University Hospital, Tours
• Contact: Arnaud CHESSE
• Phone: +33(0)2.34.37.89.68
• Email: A.CHESSE[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
France	Serrvice de Psychiatrie	Blois
France	Service de psychiatrie	Chinon
France	Service de psychiatrie	Dreux
France	Service de psychiatrie	Fleury-les-Aubrais
France	Service de psychiatrie	La Roche sur Yon
France	Service de psychiatrie	Neuilly-sur-Marne
France	Service de psychiatrie	Rennes
France	Service de psychiatrie	Saint-Maurice
France	Service de psychiatrie	Sainte-Gemmes-sur-Loire
France	Service de psychiatrie	Sotteville-lès-Rouen
France	Service de psychiatrie	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of insight	using the Introspection Self Assessment Questionnaire (IAQ)	From inclusion (T0) up to one year (T12) after randomisation
Secondary	Evolution of patient's quality of life	using the S-QOL (Subjective - Quality of Life)	From inclusion (T0) up to one year (T12) after randomisation
Secondary	Medication compliance	by the Medication Adherence Rating Scale (MARS)	From inclusion (T0) up to one year (T12) after randomisation
Secondary	Evolution of quality of life at work	Measured by the Quality of life at work scale (Elizur and Shye scale, validated in French by Delmas, 2001) for nurses. Score from 1 to 6 per question.; Average of all scores.The higher the average, the higher the level of quality of life at work.	From prior to their training in the programme up to 6 months after their first inclusion
Secondary	Evolution of psychological well-being at work	Scale of psychological well-being at work (Gilbert, Dagenais-Desmarais, & Savoie, 2011) for nurses. Score from 1 to 5 per question.; Average of all scores.The higher the average, the higher the Psychological well-being at work.	From prior to their training in the programme up to 6 months after their first inclusion
Secondary	Evolution of job satisfaction	Job satisfaction scale (Fouquereau & Rioux, 2002) for nurses. Score from 1 to 7 per question. Average of all scores. The higher the average, the higher the job satisfaction.	From prior to their training in the programme up to 6 months after their first inclusion
Secondary	Evolution of sense of self-efficacy	Self-efficacy scale (Nagels, 2008). Score from 1 to 4 per question. Average of all scores. The higher the average, the higher the sense of self-efficacy .	From prior to their training in the programme up to 6 months after their first inclusion
Secondary	Evolution of commitment to work	Work Engagement Scale (Scaufeli, Baker, & Salanova, 2006) for nurses. score from 1 to 6 per question. Average score. The higher the average, the higher the work vigour, dedication to work and absorption at work.	From prior to their training in the programme up to 6 months after their first inclusion