NCT06870305

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Apr 2029

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
4.1 years until next milestone

Study Start

First participant enrolled

April 1, 2029

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

March 6, 2025

Last Update Submit

March 24, 2026

Conditions

Clinical High Risk for Psychosis (CHR)

Keywords

Psychosismindfulness

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (40)

  • Intensity of psychotic symptoms

    3 months

  • Intensity of psychotic symptoms

    4 months

  • Intensity of psychotic symptoms

    6 months

  • Intensity of psychotic symptoms

    9 months

  • Distress related to psychotic symptoms

    3 months

  • +35 more secondary outcomes

Study Arms (2)

MBTP group

EXPERIMENTAL
Other: MBTP : Mindflulness based training for psychosis

TAU group

NO INTERVENTION

Interventions

MBTP : Mindflulness based training for psychosisOTHER

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.

MBTP group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire (CHU) de Brest

Brest, 29200, France

Location

Centre Psychothérapique de Nancy

Laxou, 54520, France

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Vincent Laprevote, PU.PH

    Centre Psychothérapique de Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William DALFIN, MD

CONTACT

03 83 92 68 22William.DALFIN@cpn-laxou.com

Naoual MELLOUKI BENDIMRED, PhD

CONTACT

0383925267unic@cpn-laxou.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 11, 2025

Study Start (Estimated)

April 1, 2029

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)