Clinical High Risk for Psychosis (CHR)EMIPNCT07499934
Experience of UHR and PEP Individuals During Mindfulness: a Qualitative Phenomenological Study
A study testing Qualitative interview in people with Clinical High Risk for Psychosis (CHR), run by Centre Psychothérapique de Nancy at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Clinical High Risk for Psychosis (CHR)
- What is being tested?
- Qualitative interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Jan 2026to 19 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- - 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Psychothérapique de Nancy
Laxou, 54520
william DALFIN, MD, +33 3 83 92 68 22, william.dalfin@cpn-laxou.com
william DALFIN, MD
- Recruiting
Clinique Fondation Santé des Etudiants de France
Vitry-le-François
Tatiana ONEA, MD, 01 45 89 43 39, tatiana.onea@fsef.net
Tatiana ONEA, MD
About this study
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.
- Conditions
- Clinical High Risk for Psychosis (CHR)
- Being tested
- Qualitative interview
- Keywords
- Psychosis, mindfulness
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interviewOther
analysis of interview data using the IPSE (Inductive Process to analyze the Structure of lived Experience) method
| Study group | Role | What they receive |
|---|---|---|
| Qualitative interview | Other | qualitative interview Receives: Other: Qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The qualitative interview takes place between one week and three months after the final session of the mindfulness-based program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start19 Jan 2026
- Primary completion19 Jan 2027 (estimated)
- Study completion19 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical High Risk for Psychosis (CHR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- william DALFIN, Principal investigator, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499934
- Sponsor's protocol ID
- 2025-A01426-43
- Other IDs
- RIPH 2024-03
- Acronym
- EMIP
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of UHR and PEP Individuals During Mindfulness: a Qualitative Phenomenological Study
- ClinicalTrials.gov ID
- NCT07499934
- Acronym / sponsor ID
- EMIP / 2025-A01426-43
- Conditions
- Clinical High Risk for Psychosis (CHR)
- Keywords
- Psychosis, mindfulness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 19 Jan 2027 (estimated)
- Study completion
- 19 Jul 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualitative interview | Other | Other: Qualitative interviewqualitative interview |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (12 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative interviewanalysis of interview data using the IPSE (Inductive Process to analyze the Structure of lived Experience) method | Other | Qualitative interview |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
william DALFIN principal investigator
Centre Psychothérapique de Nancy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative interview in people with Clinical High Risk for Psychosis (CHR), run by Centre Psychothérapique de Nancy at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William DALFIN, MD (+33 3 83 92 68 22, william.dalfin@cpn-laxou.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lived experiences (time frame: The qualitative interview takes place between one week and three months after the final session of the mindfulness-based program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.