SchizophreniaPEPITSNCT05329363
Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients
A study testing PEPITS Programme in people with Schizophrenia, run by University Hospital, Tours at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- PEPITS Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 11 sitesFrance
- Study dates
- 17 Jun 2022to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 9 recruiting
- Withdrawn
Serrvice de Psychiatrie
Blois
- Recruiting
Service de psychiatrie
Chinon
Emmanuelle BODIN
- Not yet recruiting
Service de psychiatrie
Dreux
Jessica PÉTÉ SARAROLS
Jessica PÉTÉ SARAROLS
- Withdrawn
Service de psychiatrie
Fleury-les-Aubrais
- Recruiting
Service de psychiatrie
La Roche-sur-Yon
Mathilde JOUIN
Mathilde JOUIN
- Not yet recruiting
Service de psychiatrie
Neuilly-sur-Marne
Aurélie FLORENTIN
Aurélie FLORENTIN
- Recruiting
Service de psychiatrie
Rennes
Béatrice SURGET
Béatrice SURGET
- Not yet recruiting
Service de psychiatrie
Saint-Maurice
Damien CROGUENNEC
Damien CROGUENNEC
- Recruiting
Service de psychiatrie
Sainte-Gemmes-sur-Loire
Efflam BREGEON
Efflam BREGEON
- Not yet recruiting
Service de psychiatrie
Sotteville-lès-Rouen
Hélène LECUYER
Hélène LECUYER
- Recruiting
Service de psychiatrie
Tours
Alex MONDOULET
Alex MONDOULET
About this study
Official title: 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.
- Conditions
- Schizophrenia
- Being tested
- PEPITS Programme, Usual care
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Usual careOther
Patients will receive the same psychiatric care as the experimental group except of the PEPITS programme.
| Study group | Role | What they receive |
|---|---|---|
| PEPITS programme | Experimental | Not described Receives: Diagnostic Test: PEPITS Programme |
| Usual care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of insight
using the Introspection Self Assessment Questionnaire (IAQ)
Measured: From inclusion (T0) up to one year (T12) after randomisation
Secondary outcomes (7)
Evolution of patient's quality of life
using the S-QOL (Subjective - Quality of Life)
Measured: From inclusion (T0) up to one year (T12) after randomisation
Medication compliance
by the Medication Adherence Rating Scale (MARS)
Measured: From inclusion (T0) up to one year (T12) after randomisation
Evolution of quality of life at work
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.
Measured: From prior to their training in the programme up to 6 months after their first inclusion
Evolution of psychological well-being at work
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.
Measured: From prior to their training in the programme up to 6 months after their first inclusion
Evolution of job satisfaction
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.
Measured: From prior to their training in the programme up to 6 months after their first inclusion
Evolution of sense of self-efficacy
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 .
Measured: From prior to their training in the programme up to 6 months after their first inclusion
Evolution of commitment to work
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.
Measured: From prior to their training in the programme up to 6 months after their first inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start17 Jun 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329363
- Sponsor's protocol ID
- DR190062
- Acronym
- PEPITS
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients: A Randomized, Multicenter Trial
- ClinicalTrials.gov ID
- NCT05329363
- Acronym / sponsor ID
- PEPITS / DR190062
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEPITS programme | Experimental | Diagnostic Test: PEPITS Programme |
| Usual care | Active comparator | Other: Usual care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 65 years
- Patient with a diagnosed and reported schizophrenic disorder announced :
- Or a diagnosed and reported Delusional Disorder
- Express written consent by the participant after receiving information about the study
- Be able to communicate verbally
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEPITS ProgrammeThe 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. | Diagnostic test | PEPITS programme |
| Usual carePatients will receive the same psychiatric care as the experimental group except of the PEPITS programme. | Other | Usual care |
Primary outcome
Evolution of insight
Time frame: From inclusion (T0) up to one year (T12) after randomisation
using the Introspection Self Assessment Questionnaire (IAQ)
7 secondary outcomes
Evolution of patient's quality of life
Time frame: From inclusion (T0) up to one year (T12) after randomisation
Medication compliance
Time frame: 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
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
Evolution of job satisfaction
Time frame: 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
Evolution of commitment to work
Time frame: From prior to their training in the programme up to 6 months after their first inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEPITS Programme in people with Schizophrenia, run by University Hospital, Tours at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnaud CHESSE (+33(0)2.34.37.89.68, A.CHESSE@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of insight (time frame: From inclusion (T0) up to one year (T12) after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.