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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05329363
Acronym
PEPITS
Enrollment
200
Registered
2022-04-15
Start date
2022-06-17
Completion date
2027-06-30
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

DIAGNOSTIC_TESTPEPITS 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.

OTHERUsual care

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

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evolution of insightFrom inclusion (T0) up to one year (T12) after randomisationusing the Introspection Self Assessment Questionnaire (IAQ)

Secondary

MeasureTime frameDescription
Medication complianceFrom inclusion (T0) up to one year (T12) after randomisationby the Medication Adherence Rating Scale (MARS)
Evolution of quality of life at workFrom prior to their training in the programme up to 6 months after their first inclusionMeasured 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.
Evolution of psychological well-being at workFrom prior to their training in the programme up to 6 months after their first inclusionScale 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.
Evolution of patient's quality of lifeFrom inclusion (T0) up to one year (T12) after randomisationusing the S-QOL (Subjective - Quality of Life)
Evolution of sense of self-efficacyFrom prior to their training in the programme up to 6 months after their first inclusionSelf-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 .
Evolution of commitment to workFrom prior to their training in the programme up to 6 months after their first inclusionWork 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.
Evolution of job satisfactionFrom prior to their training in the programme up to 6 months after their first inclusionJob 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.

Countries

France

Contacts

Primary ContactArnaud CHESSE
A.CHESSE@chu-tours.fr+33(0)2.34.37.89.68
Backup ContactMarie LECLERC
m.leclerc@chu-tours.fr+33(0)2.47.47.46.64

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026