Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals with an Ultra High Risk for Psychosis (EM-PREPS)

Centre Psychothérapique de Nancy

Status: Not yet enrolling

Conditions: Clinical High Risk for Psychosis (CHR)

Treatments: Other: MBTP : Mindflulness based training for psychosis

Study type: Interventional

Funder types: Other

Identifiers

NCT06870305

RIPH 2023-04 (Other Identifier)

2023-A02766-39

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

270 participants in 2 patient groups

MBTP group

Experimental group

Treatment:

Other: MBTP : Mindflulness based training for psychosis

TAU group

No Intervention group