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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Clinical High Risk for Psychosis (CHR)
• Intervention / Treatment: Other: MBTP : Mindflulness based training for psychosis

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naoual MELLOUKI BENDIMRED, PhD; Phone Number: 0383925267; Email: unic@cpn-laxou.com
• Study Contact Backup: Name: William DALFIN, MD; Phone Number: 03 83 92 68 22; Email: William.DALFIN@cpn-laxou.com

Study Locations

• France
  • Brest, France, 29200
    • Centre Hospitalier Universitaire (CHU) de Brest
    • Principal Investigator: Christophe LEMEY, MD
  • Laxou, France, 54520
    • Centre Psychothérapique de Nancy
    • Contact: William DALFIN, PU.PH; Phone Number: 03 83 92 68 22; Email: william.dalfin@cpn-laxou.com
    • Principal Investigator: vincent LAPREVOTE, PU.PH
    • Sub-Investigator: william DALFIN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBTP group	Other: MBTP : Mindflulness based training for psychosis; The group-based mindfulness programme is called MBTP (Mindfulness based training for psychosis). The MBTP programme consists of 5 sessions over a period of one month (2 sessions in the first week, then one session a week). Each session lasts approximately 1h30 and is carried out in a group of 5 participants. The sessions cover informal and formal mindfulness tasks, elements of psycho-education on emotions, meditation exercises on emotions, and thought defusion and acceptance tasks. Participants are encouraged to meditate at home between sessions.
No Intervention: TAU group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distress related to psychotic symptoms	Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention	3 months
Distress related to psychotic symptoms	Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention	4 months
Distress related to psychotic symptoms	Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention	6 months
Distress related to psychotic symptoms	Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of psychotic symptoms	Intensity of psychotic symptoms on the CAARMS scale	3 months
Intensity of psychotic symptoms	Intensity of psychotic symptoms on the CAARMS scale	4 months
Intensity of psychotic symptoms	Intensity of psychotic symptoms on the CAARMS scale	6 months
Intensity of psychotic symptoms	Intensity of psychotic symptoms on the CAARMS scale	9 months
Distress related to psychotic symptoms	Distress related to psychotic symptoms on the CAARMS scale	3 months
Distress related to psychotic symptoms	Distress related to psychotic symptoms on the CAARMS scale	4 months
Distress related to psychotic symptoms	Distress related to psychotic symptoms on the CAARMS scale	6 months
Distress related to psychotic symptoms	Distress related to psychotic symptoms on the CAARMS scale	9 months
Number of patients making a transition to psychosis	Number of patients making a transition to psychosis	3 months
Number of patients making a transition to psychosis	Number of patients making a transition to psychosis	4 months
Number of patients making a transition to psychosis	Number of patients making a transition to psychosis	6 months
Number of patients making a transition to psychosis	Number of patients making a transition to psychosis	9 months
Cognitive functions	Cognitive functions measured by the Attentional Performance Tests (APT)	3 months
Cognitive functions	Cognitive functions measured by the Attentional Performance Tests (APT)	4 months
Cognitive functions	Cognitive functions measured by the Attentional Performance Tests (APT)	6 months
Cognitive functions	Cognitive functions measured by the Attentional Performance Tests (APT)	9 months
Cognitive functions	Cognitive functions measured by the California Verbal Learning Test (CVLT)	3 months
Cognitive functions	Cognitive functions measured by the California Verbal Learning Test (CVLT)	4 months
Cognitive functions	Cognitive functions measured by the California Verbal Learning Test (CVLT)	6 months
Cognitive functions	Cognitive functions measured by the California Verbal Learning Test (CVLT)	9 months
Anxiety	Anxiety measured by the State Trait Anxiety Inventory (STAI)	3 months
Anxiety	Anxiety measured by the State Trait Anxiety Inventory (STAI)	4 months
Anxiety	Anxiety measured by the State Trait Anxiety Inventory (STAI)	6 months
Anxiety	Anxiety measured by the State Trait Anxiety Inventory (STAI)	9 months
Functioning	Functioning measured by the Personal and Social Performance Scale (PSP)	3 months
Functioning	Functioning measured by the Personal and Social Performance Scale (PSP)	4 months
Functioning	Functioning measured by the Personal and Social Performance Scale (PSP)	6 months
Functioning	Functioning measured by the Personal and Social Performance Scale (PSP)	9 months
Health-related quality of life (HRQoL)	Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire	3 months
Health-related quality of life (HRQoL)	Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire	4 months
Health-related quality of life (HRQoL)	Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire	6 months
Health-related quality of life (HRQoL)	Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire	9 months
Health-related quality of life (HRQoL)	Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.	3 months
Health-related quality of life (HRQoL)	Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.	4 months
Health-related quality of life (HRQoL)	Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.	6 months
Health-related quality of life (HRQoL)	Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.	9 months
Depressive symptoms	Depressive symptoms measured by the Beck Depression Inventory (BDI)	3 months
Depressive symptoms	Depressive symptoms measured by the Beck Depression Inventory (BDI)	4 months
Depressive symptoms	Depressive symptoms measured by the Beck Depression Inventory (BDI)	6 months
Depressive symptoms	Depressive symptoms measured by the Beck Depression Inventory (BDI)	9 months

Collaborators and Investigators

• Sponsor: Centre Psychothérapique de Nancy
• Investigators: Principal Investigator: Vincent Laprevote, PU.PH, Centre Psychothérapique de Nancy

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2029
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Psychosis; mindfulness
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Psychotic Disorders
• Other Study ID Numbers: 2023-A02766-39; RIPH 2023-04 (Other Identifier: centre Psychothérapique de Nancy CPN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No