Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-30
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding. The intervention of case managers according to the recommendations of good practices will make it possible to propose the fundamental principles of early intervention to young patients and their families on a large scale throughout the territory, namely: personalized and proactive accompaniment, psycho-education of the pathology and treatments, involvement and support of the families, and support for socio-professional reintegration

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient or their close relative must have given their free and informed consent and signed the consent form

The patient must be a member or beneficiary of a health insurance plan

The patient is available for a 3-year follow-up.

Presence of positive psychotic symptoms (delusion(s) and/or hallucination(s) and/or conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ;

Disqualifiers

The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study

The subject, or one of the parents for minor patients, refuses to sign the consent

It is impossible to give the subject informed information

The patient is under safeguard of justice or state guardianship

Trial design

Design model

Parallel

Treatments tested in this trial

  • Case management

    Other intervention

    Regular and personalized follow-up by a case manager using a "case management" approach, updated every 3 months

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: Case manager groupExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate of patients with recurrence of psychotic episode at least once between groups

Recurrence of the psychotic episode will be defined as psychiatric hospitalization with a diagnosis of psychotic disorder and/or the presence of positive psychotic symptoms according to the Positive and Negative Symptom Scale (PANSS) ≥ 4 for item P1 (delusions) and/or P2 (conceptual disorganization) and/or P3 (hallucination)) over a period of at least one week.

Time frame
3 years

Secondary outcomes

1

Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

number

Time frame
1 year
2

Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

number

Time frame
2 years
3

Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

number

Time frame
3 years
4

Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient

number

Time frame
1 year

Other outcomes

Sponsors and contacts

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