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

April 22, 2024 updated by: University Hospital, Tours

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Blois, France
        • Withdrawn
        • Serrvice de Psychiatrie
      • Chinon, France
        • Recruiting
        • Service de psychiatrie
        • Principal Investigator:
          • Emmanuelle BODIN
      • Dreux, France
        • Not yet recruiting
        • Service de psychiatrie
        • Contact:
          • Jessica PÉTÉ SARAROLS
        • Principal Investigator:
          • Jessica PÉTÉ SARAROLS
      • Fleury-les-Aubrais, France
        • Withdrawn
        • Service de psychiatrie
      • La Roche sur Yon, France
        • Recruiting
        • Service de psychiatrie
        • Contact:
          • Mathilde JOUIN
        • Principal Investigator:
          • Mathilde JOUIN
      • Neuilly-sur-Marne, France
        • Not yet recruiting
        • Service de psychiatrie
        • Contact:
          • Aurélie FLORENTIN
        • Principal Investigator:
          • Aurélie FLORENTIN
      • Rennes, France
        • Recruiting
        • Service de psychiatrie
        • Contact:
          • Béatrice SURGET
        • Principal Investigator:
          • Béatrice SURGET
      • Saint-Maurice, France
        • Not yet recruiting
        • Service de psychiatrie
        • Contact:
          • Damien CROGUENNEC
        • Principal Investigator:
          • Damien CROGUENNEC
      • Sainte-Gemmes-sur-Loire, France
        • Recruiting
        • Service de psychiatrie
        • Contact:
          • Efflam BREGEON
        • Principal Investigator:
          • Efflam BREGEON
      • Sotteville-lès-Rouen, France
        • Not yet recruiting
        • Service de psychiatrie
        • Contact:
          • Hélène LECUYER
        • Principal Investigator:
          • Hélène LECUYER
      • Tours, France
        • Recruiting
        • Service de psychiatrie
        • Contact:
          • Alex MONDOULET
        • Principal Investigator:
          • Alex MONDOULET

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual care
Other: Usual care
Patients will receive the same psychiatric care as the experimental group except of the PEPITS programme.
Experimental: PEPITS programme
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evolution of insight
Time Frame: From inclusion (T0) up to one year (T12) after randomisation
using the Introspection Self Assessment Questionnaire (IAQ)
From inclusion (T0) up to one year (T12) after randomisation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
From inclusion (T0) up to one year (T12) after randomisation
Medication compliance
Time Frame: From inclusion (T0) up to one year (T12) after randomisation
by the Medication Adherence Rating Scale (MARS)
From inclusion (T0) up to one year (T12) after randomisation
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.
From prior to their training in the programme up to 6 months after their first inclusion
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.
From prior to their training in the programme up to 6 months after their first inclusion
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.
From prior to their training in the programme up to 6 months after their first inclusion
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 .
From prior to their training in the programme up to 6 months after their first inclusion
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.
From prior to their training in the programme up to 6 months after their first inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DR190062

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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