Clinical High Risk for Psychosis (CHR)EM-PREPSNCT06870305
Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis
A study testing MBTP : Mindflulness based training for psychosis in people with Clinical High Risk for Psychosis (CHR), run by Centre Psychothérapique de Nancy at 2 sites in France.
Trial summary
The main objective is to evaluate the efficacy of a group-based mindfulness therapy programme in reducing distress associated with symptoms of UHR (Ultra High Risk) or FEP (first psychotic episode) compared with usual treatment. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Clinical High Risk for Psychosis (CHR)
- What is being tested?
- MBTP : Mindflulness based training for psychosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2029to Dec 2029
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People aged between 18 and 30 validating the criteria for UHR or PEP status on the CAARMS scale and having a social functional impact (SOFAS score below 50 or a reduction of more than 30% in the score)
Who cannot join
- Previous episode of schizophrenic disorder, schizoaffective disorder or bipolar disorder
- Previous antipsychotic treatment for more than 12 months
- Organic mental disorder or intellectual disability
- Serious suicidal/homicidal risk (but admissible if this risk has been resolved)
- Insufficient French language skills
- Adult incapable of giving consent and not under legal protection
Show all 10Show fewer
- Protection measure (guardianship/curatorship/court supervision) or under court supervision
- Person deprived of liberty by judicial or administrative decision (including forced hospitalisation)
- Persons in a life-threatening emergency
- Not affiliated to a social security regime
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
Centre Hospitalier Universitaire (CHU) de Brest
Brest, 29200
Christophe LEMEY, MD
Centre Psychothérapique de Nancy
Laxou, 54520
William DALFIN, PU.PH, 03 83 92 68 22, william.dalfin@cpn-laxou.com
vincent LAPREVOTE, PU.PH
About this study
The main objective is to evaluate the efficacy of a group-based mindfulness therapy programme in reducing distress associated with symptoms of UHR (Ultra High Risk) or FEP (first psychotic episode) compared with usual treatment. The secondary objectives were to study the efficacy of a group-based mindfulness intervention: on the reduction of psychotic symptoms; on the maintenance over time (6 months of follow-up) of the efficacy of the intervention on the distress associated with the symptoms of the UHR or PEP state; and on various dimensions associated with care: cognitive functions, anxiety, quality of life.
- Conditions
- Clinical High Risk for Psychosis (CHR)
- Being tested
- MBTP : Mindflulness based training for psychosis
- 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.
MBTP : Mindflulness based training for psychosisOther
The group-based mindfulness programme is called MBTP (Mindfulness based training for psychosis). The MBTP programme consists of 5 sessions over a period of one month (2 sessions in the first week, then one session a week). Each session lasts approximately 1h30 and is carried out in a group of 5 participants. The sessions cover informal and formal mindfulness tasks, elements of psycho-education on emotions, meditation exercises on emotions, and thought defusion and acceptance tasks. Participants are encouraged to meditate at home between sessions.
| Study group | Role | What they receive |
|---|---|---|
| MBTP group | Experimental | Not described Receives: Other: MBTP : Mindflulness based training for psychosis |
| TAU group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress related to psychotic symptoms
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Measured: 3 months
Distress related to psychotic symptoms
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Measured: 4 months
Distress related to psychotic symptoms
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Measured: 6 months
Distress related to psychotic symptoms
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Measured: 9 months
Secondary outcomes (40)
Intensity of psychotic symptoms
Intensity of psychotic symptoms on the CAARMS scale
Measured: 3 months
Intensity of psychotic symptoms
Intensity of psychotic symptoms on the CAARMS scale
Measured: 4 months
Intensity of psychotic symptoms
Intensity of psychotic symptoms on the CAARMS scale
Measured: 6 months
Intensity of psychotic symptoms
Intensity of psychotic symptoms on the CAARMS scale
Measured: 9 months
Distress related to psychotic symptoms
Distress related to psychotic symptoms on the CAARMS scale
Measured: 3 months
Distress related to psychotic symptoms
Distress related to psychotic symptoms on the CAARMS scale
Measured: 4 months
Distress related to psychotic symptoms
Distress related to psychotic symptoms on the CAARMS scale
Measured: 6 months
Distress related to psychotic symptoms
Distress related to psychotic symptoms on the CAARMS scale
Measured: 9 months
Number of patients making a transition to psychosis
Number of patients making a transition to psychosis
Measured: 3 months
Number of patients making a transition to psychosis
Number of patients making a transition to psychosis
Measured: 4 months
Number of patients making a transition to psychosis
Number of patients making a transition to psychosis
Measured: 6 months
Number of patients making a transition to psychosis
Number of patients making a transition to psychosis
Measured: 9 months
Cognitive functions
Cognitive functions measured by the Attentional Performance Tests (APT)
Measured: 3 months
Cognitive functions
Cognitive functions measured by the Attentional Performance Tests (APT)
Measured: 4 months
Cognitive functions
Cognitive functions measured by the Attentional Performance Tests (APT)
Measured: 6 months
Cognitive functions
Cognitive functions measured by the Attentional Performance Tests (APT)
Measured: 9 months
Cognitive functions
Cognitive functions measured by the California Verbal Learning Test (CVLT)
Measured: 3 months
Cognitive functions
Cognitive functions measured by the California Verbal Learning Test (CVLT)
Measured: 4 months
Cognitive functions
Cognitive functions measured by the California Verbal Learning Test (CVLT)
Measured: 6 months
Cognitive functions
Cognitive functions measured by the California Verbal Learning Test (CVLT)
Measured: 9 months
Anxiety
Anxiety measured by the State Trait Anxiety Inventory (STAI)
Measured: 3 months
Anxiety
Anxiety measured by the State Trait Anxiety Inventory (STAI)
Measured: 4 months
Anxiety
Anxiety measured by the State Trait Anxiety Inventory (STAI)
Measured: 6 months
Anxiety
Anxiety measured by the State Trait Anxiety Inventory (STAI)
Measured: 9 months
Functioning
Functioning measured by the Personal and Social Performance Scale (PSP)
Measured: 3 months
Functioning
Functioning measured by the Personal and Social Performance Scale (PSP)
Measured: 4 months
Functioning
Functioning measured by the Personal and Social Performance Scale (PSP)
Measured: 6 months
Functioning
Functioning measured by the Personal and Social Performance Scale (PSP)
Measured: 9 months
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire
Measured: 3 months
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire
Measured: 4 months
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire
Measured: 6 months
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire
Measured: 9 months
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.
Measured: 3 months
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.
Measured: 4 months
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.
Measured: 6 months
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.
Measured: 9 months
Depressive symptoms
Depressive symptoms measured by the Beck Depression Inventory (BDI)
Measured: 3 months
Depressive symptoms
Depressive symptoms measured by the Beck Depression Inventory (BDI)
Measured: 4 months
Depressive symptoms
Depressive symptoms measured by the Beck Depression Inventory (BDI)
Measured: 6 months
Depressive symptoms
Depressive symptoms measured by the Beck Depression Inventory (BDI)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study startApr 2029 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionDec 2029 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Laprevote, PU.PH, Principal investigator, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870305
- Sponsor's protocol ID
- 2023-A02766-39
- Other IDs
- RIPH 2023-04
- Acronym
- EM-PREPS
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis
- ClinicalTrials.gov ID
- NCT06870305
- Acronym / sponsor ID
- EM-PREPS / 2023-A02766-39
- Conditions
- Clinical High Risk for Psychosis (CHR)
- Keywords
- Psychosis, mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Study start
- Apr 2029 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 11 Mar 2025 (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 main objective is to evaluate the efficacy of a group-based mindfulness therapy programme in reducing distress associated with symptoms of UHR (Ultra High Risk) or FEP (first psychotic episode) compared with usual treatment. The secondary objectives were to study the efficacy of a group-based mindfulness intervention: on the reduction of psychotic symptoms; on the maintenance over time (6 months of follow-up) of the efficacy of the intervention on the distress associated with the symptoms of the UHR or PEP state; and on various dimensions associated with care: cognitive functions, anxiety, quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBTP group | Experimental | Other: MBTP : Mindflulness based training for psychosis |
| TAU group | No intervention | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- People aged between 18 and 30 validating the criteria for UHR or PEP status on the CAARMS scale and having a social functional impact (SOFAS score below 50 or a reduction of more than 30% in the score)
Key exclusion criteria (10 listed)
- Previous episode of schizophrenic disorder, schizoaffective disorder or bipolar disorder
- Previous antipsychotic treatment for more than 12 months
- Organic mental disorder or intellectual disability
- Serious suicidal/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 |
|---|---|---|
| MBTP : Mindflulness based training for psychosisThe group-based mindfulness programme is called MBTP (Mindfulness based training for psychosis). The MBTP programme consists of 5 sessions over a period of one month (2 sessions in the first week, then one session a week). Each session lasts approximately 1h30 and is carried out in a group of 5 participants. The sessions cover informal and formal mindfulness tasks, elements of psycho-education on emotions, meditation exercises on emotions, and thought defusion and acceptance tasks. Participants are encouraged to meditate at home between sessions. | Other | MBTP group |
Primary outcome
Distress related to psychotic symptoms
Time frame: 3 months
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Distress related to psychotic symptoms
Time frame: 4 months
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Distress related to psychotic symptoms
Time frame: 6 months
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Distress related to psychotic symptoms
Time frame: 9 months
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
40 secondary outcomes
Intensity of psychotic symptoms
Time frame: 3 months
Intensity of psychotic symptoms
Time frame: 4 months
Intensity of psychotic symptoms
Time frame: 6 months
Intensity of psychotic symptoms
Time frame: 9 months
Distress related to psychotic symptoms
Time frame: 3 months
Distress related to psychotic symptoms
Time frame: 4 months
Distress related to psychotic symptoms
Time frame: 6 months
Distress related to psychotic symptoms
Time frame: 9 months
Number of patients making a transition to psychosis
Time frame: 3 months
Number of patients making a transition to psychosis
Time frame: 4 months
Number of patients making a transition to psychosis
Time frame: 6 months
Number of patients making a transition to psychosis
Time frame: 9 months
Cognitive functions
Time frame: 3 months
Cognitive functions
Time frame: 4 months
Cognitive functions
Time frame: 6 months
Cognitive functions
Time frame: 9 months
Cognitive functions
Time frame: 3 months
Cognitive functions
Time frame: 4 months
Cognitive functions
Time frame: 6 months
Cognitive functions
Time frame: 9 months
Anxiety
Time frame: 3 months
Anxiety
Time frame: 4 months
Anxiety
Time frame: 6 months
Anxiety
Time frame: 9 months
Functioning
Time frame: 3 months
Functioning
Time frame: 4 months
Functioning
Time frame: 6 months
Functioning
Time frame: 9 months
Health-related quality of life (HRQoL)
Time frame: 3 months
Health-related quality of life (HRQoL)
Time frame: 4 months
Health-related quality of life (HRQoL)
Time frame: 6 months
Health-related quality of life (HRQoL)
Time frame: 9 months
Health-related quality of life (HRQoL)
Time frame: 3 months
Health-related quality of life (HRQoL)
Time frame: 4 months
Health-related quality of life (HRQoL)
Time frame: 6 months
Health-related quality of life (HRQoL)
Time frame: 9 months
Depressive symptoms
Time frame: 3 months
Depressive symptoms
Time frame: 4 months
Depressive symptoms
Time frame: 6 months
Depressive symptoms
Time frame: 9 months
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 25 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Vincent Laprevote, PU.PH 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 MBTP : Mindflulness based training for psychosis 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 10 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: opening soon, as of the sponsor's last update on 25 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 (03 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?
Distress related to psychotic symptoms (time frame: 3 months). The study lists 4 primary outcomes in all. 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 25 Mar 2026.