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Clinical Trials/NCT04867681
NCT04867681
Active, not recruiting
Not Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country40 target enrollmentDecember 8, 2021
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
40
Locations
1
Primary Endpoint
Therapeutic alliance scale
Status
Active, not recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 8, 2021
End Date
April 24, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Therapeutic alliance scale

Time Frame: 3 months

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 ").

Study Sites (1)

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