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Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis

Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06870305
Acronym
EM-PREPS
Enrollment
270
Registered
2025-03-11
Start date
2029-04-01
Completion date
2029-12-01
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical High Risk for Psychosis (CHR)

Keywords

Psychosis, mindfulness

Brief 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. 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.

Interventions

OTHERMBTP : Mindflulness based training for psychosis

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.

Sponsors

Centre Psychothérapique de Nancy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Distress related to psychotic symptoms3 monthsDistress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention

Secondary

MeasureTime frameDescription
Intensity of psychotic symptoms3 monthsIntensity of psychotic symptoms on the CAARMS scale
Distress related to psychotic symptoms3 monthsDistress related to psychotic symptoms on the CAARMS scale
Number of patients making a transition to psychosis3 monthsNumber of patients making a transition to psychosis
Cognitive functions3 monthsCognitive functions measured by the Attentional Performance Tests (APT)
Anxiety3 monthsAnxiety measured by the State Trait Anxiety Inventory (STAI)
Functioning3 monthsFunctioning measured by the Personal and Social Performance Scale (PSP)
Health-related quality of life (HRQoL)3 monthsHealth-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire
Depressive symptoms3 monthsDepressive symptoms measured by the Beck Depression Inventory (BDI)

Countries

France

Contacts

CONTACTWilliam DALFIN, MD
William.DALFIN@cpn-laxou.com03 83 92 68 22
CONTACTNaoual MELLOUKI BENDIMRED, PhD
unic@cpn-laxou.com0383925267
PRINCIPAL_INVESTIGATORVincent Laprevote, PU.PH

Centre Psychothérapique de Nancy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026