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Not yet recruiting NCT06870305

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

No phase Interventional Clinical High Risk for Psychosis (CHR)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MBTP : Mindflulness based training for psychosis.
Who it may be relevant to
Registry conditions: Clinical High Risk for Psychosis (CHR). Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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

Primary outcome measures

  • Distress related to psychotic symptoms [Time frame: 3 months]
  • Distress related to psychotic symptoms [Time frame: 4 months]
  • Distress related to psychotic symptoms [Time frame: 6 months]
  • Distress related to psychotic symptoms [Time frame: 9 months]
Secondary outcome measures (12)
  • Intensity of psychotic symptoms [Time frame: 3 months]
  • Intensity of psychotic symptoms [Time frame: 4 months]
  • Intensity of psychotic symptoms [Time frame: 6 months]
  • Intensity of psychotic symptoms [Time frame: 9 months]
  • Distress related to psychotic symptoms [Time frame: 3 months]
  • Distress related to psychotic symptoms [Time frame: 4 months]
  • Distress related to psychotic symptoms [Time frame: 6 months]
  • Distress related to psychotic symptoms [Time frame: 9 months]
  • Number of patients making a transition to psychosis [Time frame: 3 months]
  • Number of patients making a transition to psychosis [Time frame: 4 months]
  • Number of patients making a transition to psychosis [Time frame: 6 months]
  • Number of patients making a transition to psychosis [Time frame: 9 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 2 centers
  • Centre Hospitalier Universitaire (CHU) de Brest — Brest
  • Centre Psychothérapique de Nancy — Laxou

Identifiers

NCT: NCT06870305 · 2023-A02766-39 · RIPH 2023-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗