NCT05329363

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
12mo left

Started Jun 2022

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jun 2022Jun 2027

First Submitted

Initial submission to the registry

March 18, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 17, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

4 years

First QC Date

March 18, 2022

Last Update Submit

April 22, 2024

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Evolution of insight

    using the Introspection Self Assessment Questionnaire (IAQ)

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

Secondary Outcomes (7)

  • 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 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

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

  • Evolution of job satisfaction

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

  • +2 more secondary outcomes

Study Arms (2)

PEPITS programme

EXPERIMENTAL
Diagnostic Test: PEPITS Programme

Usual care

ACTIVE COMPARATOR
Other: Usual care

Interventions

PEPITS ProgrammeDIAGNOSTIC_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.

PEPITS programme
Usual careOTHER

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

Usual care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Serrvice de Psychiatrie

Blois, France

WITHDRAWN

Service de psychiatrie

Chinon, France

RECRUITING

Service de psychiatrie

Dreux, France

NOT YET RECRUITING

Service de psychiatrie

Fleury-les-Aubrais, France

WITHDRAWN

Service de psychiatrie

La Roche-sur-Yon, France

RECRUITING

Service de psychiatrie

Neuilly-sur-Marne, France

NOT YET RECRUITING

Service de psychiatrie

Rennes, France

RECRUITING

Service de psychiatrie

Saint-Maurice, France

NOT YET RECRUITING

Service de psychiatrie

Sainte-Gemmes-sur-Loire, France

RECRUITING

Service de psychiatrie

Sotteville-lès-Rouen, France

NOT YET RECRUITING

Service de psychiatrie

Tours, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Arnaud CHESSE

CONTACT

+33(0)2.34.37.89.68A.CHESSE@chu-tours.fr

Marie LECLERC

CONTACT

+33(0)2.47.47.46.64m.leclerc@chu-tours.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2022

First Posted

April 15, 2022

Study Start

June 17, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

FR(11)