Study of the Impact on the Therapeutic Alliance of a Short Initial Psychoeducation Programme in Patients With Early Schizophrenia (EPPICS)
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psycho-education programme
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- French speaking
Presenting a first or second acute psychotic episode, corresponding according to DSM 5 criteria to:
- A brief psychotic disorder
- And/or a schizophrenic disorder evolving for less than 2 years,
- Hospitalized in full time or in day care,
- Understanding and accepting the constraints of the study,
Exclusion Criteria:
- Patient under guardianship
- Patient participating in another study
- Patient in hospital under restraint
Sites / Locations
- CHU de NiceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Administration of a short psycho-education programme
Control group
Arm Description
Outcomes
Primary Outcome Measures
Therapeutic alliance scale
Mean change in the HAq-IIp therapeutic alliance score at 3 months after administration of the psycoeducation programme, compared between the active and control arms.
This is a self-questionnaire evaluating the patient's subjective perception of his relationship with his therapist using 19 items, graded from 1 ("totally disagree") to 6 ("completely All right ").
Secondary Outcome Measures
Full Information
NCT ID
NCT04867681
First Posted
April 28, 2021
Last Updated
June 13, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04867681
Brief Title
Study of the Impact on the Therapeutic Alliance of a Short Initial Psychoeducation Programme in Patients With Early Schizophrenia
Acronym
EPPICS
Official Title
Study of the Impact on the Therapeutic Alliance of a Short Initial Psychoeducation Programme in Patients With Early Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Schizophrenia is a serious, disabling and unfortunately common disease. Its prevalence is in the order of 0.6 to 1% in the general population, a figure that remains relatively stable in the various cultures. The overall prognosis, particularly in terms of function, remains largely negative. The investigators know that a global management can considerably slow down this unfavourable evolution: according to the recommendations, the patient suffering from schizophrenia requires an effective and well-tolerated pharmacotherapy, associated with an adapted psychotherapy as well as cognitive remediation workshops, training in social skills, and psycho-education. There are indeed a large number of studies that have shown these elements in patients with schizophrenic disorders that have been present for several years. The investigators now know that early treatment is a key prognostic element. Indeed, the earlier care is provided during the first psychotic episode, the better the subsequent prognosis: the probability of further decompensation is reduced, as is the risk of developing deficits, such as cognitive difficulties. However, there is a lack of access to all the recommended aspects of management in the initial phase of the disorder, particularly concerning early psycho-educational programmes for patients, which have been relatively little studied in clinical research. In this context, it seems relevant to study the impact of a new programme of this type on a fundamental parameter, conditioning the subsequent access to care: the therapeutic alliance. "PPIC" is a short psycho-educational programme in 4 sessions, specifically designed to accompany young patients, and focused on the issues of this crucial period of the care process.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Administration of a short psycho-education programme
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Psycho-education programme
Intervention Description
4 individual sessions (S1, S2, S3, S4) of one hour each spread over 2 weeks, i.e. 2 sessions per week. S1 explains the different clinical signs and discusses the prognosis of the disease, S2 deals with the question of drug treatments, their different forms and their mechanisms of action. S3 discusses the evolution of the disease and the organisation of the care pathway. Finally, S4 looks at the aspects of quality of life, lifestyle and the fight against addictive co-morbidities, and concludes with a review of the patient's motivation and involvement in the subjects covered.
Primary Outcome Measure Information:
Title
Therapeutic alliance scale
Description
Mean change in the HAq-IIp therapeutic alliance score at 3 months after administration of the psycoeducation programme, compared between the active and control arms.
This is a self-questionnaire evaluating the patient's subjective perception of his relationship with his therapist using 19 items, graded from 1 ("totally disagree") to 6 ("completely All right ").
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
French speaking
Presenting a first or second acute psychotic episode, corresponding according to DSM 5 criteria to:
A brief psychotic disorder
And/or a schizophrenic disorder evolving for less than 2 years,
Hospitalized in full time or in day care,
Understanding and accepting the constraints of the study,
Exclusion Criteria:
Patient under guardianship
Patient participating in another study
Patient in hospital under restraint
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno GIORDANA, Dr
Phone
4 92 03 87 75
Ext
+33
Email
giordana.b@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno GIORDANA, Dr
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno GIORDANA, Dr
Phone
4 92 03 87 75
Ext
+33
Email
giordana.b@chu-nice.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Impact on the Therapeutic Alliance of a Short Initial Psychoeducation Programme in Patients With Early Schizophrenia
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