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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorCentre Psychothérapique de Nancy

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • MBTP : Mindflulness based training for psychosis

    Other intervention

    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.

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: MBTP groupExperimental treatment 1 intervention
Group B: TAU groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Distress related to psychotic symptoms

Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention

Time frame
3 months
2

Distress related to psychotic symptoms

Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention

Time frame
4 months
3

Distress related to psychotic symptoms

Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention

Time frame
6 months
4

Distress related to psychotic symptoms

Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention

Time frame
9 months

Secondary outcomes

1

Intensity of psychotic symptoms

Intensity of psychotic symptoms on the CAARMS scale

Time frame
3 months
2

Intensity of psychotic symptoms

Intensity of psychotic symptoms on the CAARMS scale

Time frame
4 months
3

Intensity of psychotic symptoms

Intensity of psychotic symptoms on the CAARMS scale

Time frame
6 months
4

Intensity of psychotic symptoms

Intensity of psychotic symptoms on the CAARMS scale

Time frame
9 months

Other outcomes

Sponsors and contacts

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