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

March 24, 2026 updated by: Centre Psychothérapique de Nancy
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Naoual MELLOUKI BENDIMRED, PhD
  • Phone Number: 33 0383925267
  • Email: unic@cpn-laxou.com

Study Contact Backup

Study Locations

  • France
      • Laxou, France, 54520
        • Recruiting
        • Centre Psychothérapique de Nancy
        • Contact:
        • Principal Investigator:
          • william DALFIN, MD
      • Vitry-le-François, France
        • Recruiting
        • Clinique Fondation Santé des Etudiants de France
        • Contact:
        • Principal Investigator:
          • Tatiana ONEA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Qualitative interview
qualitative interview
Other: Qualitative interview
analysis of interview data using the IPSE (Inductive Process to analyze the Structure of lived Experience) method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lived experiences
Time Frame: The qualitative interview takes place between one week and three months after the final session of the mindfulness-based program
To explore and describe the lived experiences of individuals with UHR or FEP who have participated in a group-based mindfulness intervention using the IPSE method.
The qualitative interview takes place between one week and three months after the final session of the mindfulness-based program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Psychothérapique de Nancy

Investigators

  • Principal Investigator: william DALFIN, Centre Psychothérapique de Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2026

Primary Completion (Estimated)

January 19, 2027

Study Completion (Estimated)

July 19, 2027

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A01426-43
  • RIPH 2024-03 (Other Identifier: centre Psychothérapique de Nancy CPN)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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