NCT06870305Not yet recruiting
Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 6 Mar 2025
- Start date
- Apr 2029
- Primary completion date
- Apr 2029
- Lead sponsor
- Centre Psychothérapique de Nancy
- Diseases
- Schizophrenia
- NCT number
- NCT06870305
What you commit to
- Study type: Interventional
- Planned participants: 270
- From Apr 2029 to the primary completion date, Apr 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous episode of schizophrenic disorder, schizoaffective disorder or bipolar disorder
- Previous antipsychotic treatment for more than 12 months
Other illness
- Organic mental disorder or intellectual disability
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 30 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire (CHU) de Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Centre Psychothérapique de Nancy Coordinator of this site? Confirm its status | Laxou | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.