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Recruiting NCT07499934

Experience of UHR and PEP Individuals During Mindfulness: a Qualitative Phenomenological Study

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: Qualitative interview.
Who it may be relevant to
Registry conditions: Clinical High Risk for Psychosis (CHR). Basic parameters: 15 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 →

Unsure about the terms? Read our patient guide →

Overview

The goal of this qualitative study is to explore and describe the lived experiences of individuals at ultra-high risk (UHR) or first episode of psychosis (FEP) who have participated in a group-based mindfulness-based intervention. Secondary objectives include identifying potential adverse effects of a group-based mindfulness-based intervention among UHR or FEP.

Interventions

  • Other Qualitative interview
    analysis of interview data using the IPSE (Inductive Process to analyze the Structure of lived Experience) method

Primary outcome measures

  • Lived experiences [Time frame: The qualitative interview takes place between one week and three months after the final session of the mindfulness-based program]

Eligibility criteria

Inclusion criteria

  • People aged between 15 and 30 years who meet the criteria for UHR or PEP status on the CAARMS scale and have a social functional impact (SOFAS score less than 50 or a decrease of more than 30% in the score)

Exclusion criteria

  • \- Previous episode of schizophrenia, schizoaffective disorder, or bipolar disorder
  • Previous antipsychotic treatment for more than 12 months
  • Organic mental disorder or intellectual disability
  • Serious suicide/homicidal risk (but admissible if this risk has been resolved)
  • Insufficient French language skills
  • Adult unable to give consent and not under legal guardianship
  • Protective measure (guardianship/conservatorship/judicial protection) or under judicial supervision
  • Person deprived of liberty by judicial or administrative decision (including actual involuntary hospitalization)
  • Persons in a life-threatening emergency
  • Not affiliated with a social security scheme
  • Minors without parental authorization
  • Person who refused the audio recording of the interview

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 2 centers
  • Centre Psychothérapique de Nancy — Laxou
  • Clinique Fondation Santé des Etudiants de France — Vitry-le-François

Identifiers

NCT: NCT07499934 · 2025-A01426-43 · RIPH 2024-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗