Clinical trial NCT06870305: Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis
Official title: Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clinical High Risk for Psychosis (CHR)
Keywords: Psychosis
mindfulness
Lead sponsor: Centre Psychothérapique de Nancy
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is to evaluate the efficacy of a group-based mindfulness therapy programme in reducing distress associated with symptoms of UHR (Ultra High Risk) or FEP (first psychotic episode) compared with usual treatment. The secondary objectives were to study the efficacy of a group-based mindfulness intervention: on the reduction of psychotic symptoms; on the maintenance over time (6 months of follow-up) of the efficacy of the intervention on the distress associated with the symptoms of the UHR or PEP state; and on various dimensions associated with care: cognitive functions, anxiety, quality of life.


Eligibility criteria: Inclusion Criteria:

* People aged between 18 and 30 validating the criteria for UHR or PEP status on the CAARMS scale and having a social functional impact (SOFAS score below 50 or a reduction of more than 30% in the score)

Exclusion Criteria:

* Previous episode of schizophrenic disorder, schizoaffective disorder or bipolar disorder
* Previous antipsychotic treatment for more than 12 months
* Organic mental disorder or intellectual disability
* Serious suicidal/homicidal risk (but admissible if this risk has been resolved)
* Insufficient French language skills
* Adult incapable of giving consent and not under legal protection
* Protection measure (guardianship/curatorship/court supervision) or under court supervision
* Person deprived of liberty by judicial or administrative decision (including forced hospitalisation)
* Persons in a life-threatening emergency
* Not affiliated to a social security regime

Primary outcomes:
measure: Distress related to psychotic symptoms
timeFrame: 3 months
measure: Distress related to psychotic symptoms
timeFrame: 4 months
measure: Distress related to psychotic symptoms
timeFrame: 6 months
measure: Distress related to psychotic symptoms
timeFrame: 9 months
Secondary outcomes:
measure: Intensity of psychotic symptoms
timeFrame: 3 months
measure: Intensity of psychotic symptoms
timeFrame: 4 months
measure: Intensity of psychotic symptoms
timeFrame: 6 months
measure: Intensity of psychotic symptoms
timeFrame: 9 months
measure: Distress related to psychotic symptoms
timeFrame: 3 months
measure: Distress related to psychotic symptoms
timeFrame: 4 months
measure: Distress related to psychotic symptoms
timeFrame: 6 months
measure: Distress related to psychotic symptoms
timeFrame: 9 months
measure: Number of patients making a transition to psychosis
timeFrame: 3 months
measure: Number of patients making a transition to psychosis
timeFrame: 4 months
measure: Number of patients making a transition to psychosis
timeFrame: 6 months
measure: Number of patients making a transition to psychosis
timeFrame: 9 months
measure: Cognitive functions
timeFrame: 3 months
measure: Cognitive functions
timeFrame: 4 months
measure: Cognitive functions
timeFrame: 6 months
measure: Cognitive functions
timeFrame: 9 months
measure: Cognitive functions
timeFrame: 3 months
measure: Cognitive functions
timeFrame: 4 months
measure: Cognitive functions
timeFrame: 6 months
measure: Cognitive functions
timeFrame: 9 months
measure: Anxiety
timeFrame: 3 months
measure: Anxiety
timeFrame: 4 months
measure: Anxiety
timeFrame: 6 months
measure: Anxiety
timeFrame: 9 months
measure: Functioning
timeFrame: 3 months
measure: Functioning
timeFrame: 4 months
measure: Functioning
timeFrame: 6 months
measure: Functioning
timeFrame: 9 months
measure: Health-related quality of life (HRQoL)
timeFrame: 3 months
measure: Health-related quality of life (HRQoL)
timeFrame: 4 months
measure: Health-related quality of life (HRQoL)
timeFrame: 6 months
measure: Health-related quality of life (HRQoL)
timeFrame: 9 months
measure: Health-related quality of life (HRQoL)
timeFrame: 3 months
measure: Health-related quality of life (HRQoL)
timeFrame: 4 months
measure: Health-related quality of life (HRQoL)
timeFrame: 6 months
measure: Health-related quality of life (HRQoL)
timeFrame: 9 months
measure: Depressive symptoms
timeFrame: 3 months
measure: Depressive symptoms
timeFrame: 4 months
measure: Depressive symptoms
timeFrame: 6 months
measure: Depressive symptoms
timeFrame: 9 months
Other outcomes:
Locations:
city: Brest
country: France
facility: Centre Hospitalier Universitaire (CHU) de Brest
city: Laxou
country: France
facility: Centre Psychothérapique de Nancy
Study officials:
affiliation: Centre Psychothérapique de Nancy
name: Vincent Laprevote, PU.PH
role: PRINCIPAL_INVESTIGATOR
References: