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NCT Number: NCT05329363

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Serrvice de Psychiatrie, Blois, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEPITS Programme

Diagnostic Test

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.

Usual Care

Other

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

Primary outcomes

  1. Evolution of insight

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

    using the Introspection Self Assessment Questionnaire (IAQ)

Secondary outcomes

  1. Evolution of patient's quality of life

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

    using the S-QOL (Subjective - Quality of Life)

  2. Medication compliance

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

    by the Medication Adherence Rating Scale (MARS)

  3. Evolution of quality of life at work

    Time frame: From prior to their training in the programme up to 6 months after their first inclusion

    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.

  4. Evolution of psychological well-being at work

    Time frame: From prior to their training in the programme up to 6 months after their first inclusion

    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.

  5. Evolution of job satisfaction

    Time frame: From prior to their training in the programme up to 6 months after their first inclusion

    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.

  6. Evolution of sense of self-efficacy

    Time frame: From prior to their training in the programme up to 6 months after their first inclusion

    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 .

  7. Evolution of commitment to work

    Time frame: From prior to their training in the programme up to 6 months after their first inclusion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Arnaud CHESSE

CONTACT

[email protected]

+33(0)2.34.37.89.68

Marie LECLERC

CONTACT

[email protected]

+33(0)2.47.47.46.64

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: PEPITS

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 15, 2022
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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