Study of the Impact on the Therapeutic Alliance of a Short Initial Psychoeducation Programme in Patients With Early Schizophrenia

NCT ID: NCT04867681

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-08
• Study Completion Date: 2026-04-24

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Administration of a short psycho-education programme

Group Type: EXPERIMENTAL

Psycho-education programme

Intervention Type: BEHAVIORAL

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.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psycho-education programme

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno GIORDANA, Dr

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nice

Locations

CHU de Nice

Nice, , France

Countries

France

Other Identifiers

18-AOI-06

Identifier Type: -

Identifier Source: org_study_id