NCT07499934

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jan 2026

Geographic Reach
1 country

2 active sites

Status
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

Study Progress27%
Jan 2026Jul 2027

Study Start

First participant enrolled

January 19, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 24, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

Psychosismindfulness

Outcome Measures

Primary Outcomes (1)

  • Lived experiences

    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

Study Arms (1)

Qualitative interview

OTHER

qualitative interview

Other: Qualitative interview

Interventions

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

Qualitative interview

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Psychothérapique de Nancy

Laxou, 54520, France

RECRUITING

Clinique Fondation Santé des Etudiants de France

Vitry-le-François, France

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • william DALFIN

    Centre Psychothérapique de Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naoual MELLOUKI BENDIMRED, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

January 19, 2026

Primary Completion (Estimated)

January 19, 2027

Study Completion (Estimated)

July 19, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations