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

Sponsor
University Hospital, Tours (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05329363
Collaborator
(none)
200
8
2
36
25
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PEPITS Programme
  • Other: Usual care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients: A Randomized, Multicenter Trial
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

Active Comparator: Usual care

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

Outcome Measures

Primary Outcome Measures

  1. Evolution of insight [From inclusion (T0) up to one year (T12) after randomisation]

    using the Introspection Self Assessment Questionnaire (IAQ)

Secondary Outcome Measures

  1. Evolution of patient's quality of life [From inclusion (T0) up to one year (T12) after randomisation]

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

  2. Medication compliance [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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 3 years

  • Patient under legal protection or guardianship

Contacts and Locations

Locations

Site City State Country Postal Code
1 Serrvice de Psychiatrie Blois France
2 Service de psychiatrie Chinon France
3 Service de psychiatrie Dreux France
4 Service de psychiatrie Fleury-les-Aubrais France
5 Service de psychiatrie La Roche sur Yon France
6 Service de psychiatrie Rennes France
7 Service de psychiatrie Sainte-Gemmes-sur-Loire France
8 Service de psychiatrie Tours France

Sponsors and Collaborators

  • University Hospital, Tours

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT05329363
Other Study ID Numbers:
  • DR190062
First Posted:
Apr 15, 2022
Last Update Posted:
Apr 15, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022