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ClinicalTrials.gov ID

NCT06870305

Lead Sponsor

Centre Psychothérapique de NancyOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

270Estimated

Last Update Posted

Mar 25, 2026Actual

Start Date

Apr 2029Estimated

Primary Completion Date

Apr 2029Estimated

Completion Date

Dec 2029Estimated

Official Title

Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis

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.

• Clinical High Risk for Psychosis (CHR)

• MBTP : Mindflulness based training for psychosis

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Centre Psychothérapique de NancyOTHER

william.dalfin@cpn-laxou.com03 83 92 68 22