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Clinical Trials/NCT05329363
NCT05329363
Recruiting
Not Applicable

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

University Hospital, Tours2 sites in 1 country200 target enrollmentJune 17, 2022
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
University Hospital, Tours
Enrollment
200
Locations
2
Primary Endpoint
Evolution of insight
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 17, 2022
End Date
June 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Evolution of insight

Time Frame: From inclusion (T0) up to one year (T12) after randomisation

using the Introspection Self Assessment Questionnaire (IAQ)

Secondary Outcomes

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

Study Sites (2)

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