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

Study Overview
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Diagnostic Test: PEPITS Programme
* Other: Usual care


Participation Criteria
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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 3 years Patient under legal protection or guardianship

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEPITS programme<br> | Diagnostic Test: PEPITS Programme<br>* 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.<br>|
| Active Comparator: Usual care<br> | Other: Usual care<br>* Patients will receive the same psychiatric care as the experimental group except of the PEPITS programme.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of insight | using the Introspection Self Assessment Questionnaire (IAQ) | From inclusion (T0) up to one year (T12) after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Medication compliance | by the Medication Adherence Rating Scale (MARS) | From inclusion (T0) up to one year (T12) after randomisation | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |