Experience of UHR and PEP Individuals During Mindfulness:... | NCT07499934

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

NCT07499934

Sponsor

Centre Psychothérapique de Nancy

Status

Recruiting

Last Update Posted

Mar 30, 2026Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Clinical High Risk for Psychosis (CHR)

Interventions

Qualitative interview

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RIPH 2024-03	Other Identifier	centre Psychothérapique de Nancy CPN

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 2026Actual

Primary Completion Date

Jan 19, 2027Estimated

Completion Date

Jul 19, 2027Estimated

First Submitted Date

Mar 24, 2026

First Submission Date that Met QC Criteria

Mar 24, 2026

First Posted Date

Mar 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2026

Last Update Posted Date

Mar 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Qualitative interview	Other	qualitative interview	Other: Qualitative interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Qualitative interview	Other	analysis of interview data using the IPSE (Inductive Process to analyze the Structure of lived Experience) method	Qualitative interview

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
William DALFIN, MD	Contact	+33 3 83 92 68 22		william.dalfin@cpn-laxou.com
Naoual MELLOUKI BENDIMRED, PhD	Contact	0383925267	33	unic@cpn-laxou.com

Overall Officials

Name	Affiliation	Role
william DALFIN	Centre Psychothérapique de Nancy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Psychothérapique de Nancy	Recruiting	Laxou		54520	France

Condition Browse Module

MeSH Terms

ID	Term
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided