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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04867681
Acronym
EPPICS
Enrollment
21
Registered
2021-04-30
Start date
2021-12-08
Completion date
2026-05-19
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

BEHAVIORALPsycho-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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Therapeutic alliance scale3 monthsMean 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 ").

Countries

France

Contacts

STUDY_DIRECTORBruno GIORDANA, Dr

Centre Hospitalier Universitaire de Nice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026