About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
MBTP : Mindflulness based training for psychosis
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Distress related to psychotic symptoms
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Distress related to psychotic symptoms
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Distress related to psychotic symptoms
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Distress related to psychotic symptoms
Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention
Secondary outcomes
Intensity of psychotic symptoms
Intensity of psychotic symptoms on the CAARMS scale
Intensity of psychotic symptoms
Intensity of psychotic symptoms on the CAARMS scale
Intensity of psychotic symptoms
Intensity of psychotic symptoms on the CAARMS scale
Intensity of psychotic symptoms
Intensity of psychotic symptoms on the CAARMS scale
Sponsors and contacts
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