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NCT Number: NCT06870305

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

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.

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Key information

Conditions

Clinical High Risk for Psychosis (CHR) Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire (CHU) de Brest, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBTP : Mindflulness based training for psychosis

Other

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.

Primary outcomes

  1. Distress related to psychotic symptoms

    Time frame: 3 months

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

  2. Distress related to psychotic symptoms

    Time frame: 4 months

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

  3. Distress related to psychotic symptoms

    Time frame: 6 months

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

  4. Distress related to psychotic symptoms

    Time frame: 9 months

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

Secondary outcomes

  1. Intensity of psychotic symptoms

    Time frame: 3 months

    Intensity of psychotic symptoms on the CAARMS scale

  2. Intensity of psychotic symptoms

    Time frame: 4 months

    Intensity of psychotic symptoms on the CAARMS scale

  3. Intensity of psychotic symptoms

    Time frame: 6 months

    Intensity of psychotic symptoms on the CAARMS scale

  4. Intensity of psychotic symptoms

    Time frame: 9 months

    Intensity of psychotic symptoms on the CAARMS scale

  5. Distress related to psychotic symptoms

    Time frame: 3 months

    Distress related to psychotic symptoms on the CAARMS scale

  6. Distress related to psychotic symptoms

    Time frame: 4 months

    Distress related to psychotic symptoms on the CAARMS scale

  7. Distress related to psychotic symptoms

    Time frame: 6 months

    Distress related to psychotic symptoms on the CAARMS scale

  8. Distress related to psychotic symptoms

    Time frame: 9 months

    Distress related to psychotic symptoms on the CAARMS scale

  9. Number of patients making a transition to psychosis

    Time frame: 3 months

    Number of patients making a transition to psychosis

  10. Number of patients making a transition to psychosis

    Time frame: 4 months

    Number of patients making a transition to psychosis

  11. Number of patients making a transition to psychosis

    Time frame: 6 months

    Number of patients making a transition to psychosis

  12. Number of patients making a transition to psychosis

    Time frame: 9 months

    Number of patients making a transition to psychosis

  13. Cognitive functions

    Time frame: 3 months

    Cognitive functions measured by the Attentional Performance Tests (APT)

  14. Cognitive functions

    Time frame: 4 months

    Cognitive functions measured by the Attentional Performance Tests (APT)

  15. Cognitive functions

    Time frame: 6 months

    Cognitive functions measured by the Attentional Performance Tests (APT)

  16. Cognitive functions

    Time frame: 9 months

    Cognitive functions measured by the Attentional Performance Tests (APT)

  17. Cognitive functions

    Time frame: 3 months

    Cognitive functions measured by the California Verbal Learning Test (CVLT)

  18. Cognitive functions

    Time frame: 4 months

    Cognitive functions measured by the California Verbal Learning Test (CVLT)

  19. Cognitive functions

    Time frame: 6 months

    Cognitive functions measured by the California Verbal Learning Test (CVLT)

  20. Cognitive functions

    Time frame: 9 months

    Cognitive functions measured by the California Verbal Learning Test (CVLT)

  21. Anxiety

    Time frame: 3 months

    Anxiety measured by the State Trait Anxiety Inventory (STAI)

  22. Anxiety

    Time frame: 4 months

    Anxiety measured by the State Trait Anxiety Inventory (STAI)

  23. Anxiety

    Time frame: 6 months

    Anxiety measured by the State Trait Anxiety Inventory (STAI)

  24. Anxiety

    Time frame: 9 months

    Anxiety measured by the State Trait Anxiety Inventory (STAI)

  25. Functioning

    Time frame: 3 months

    Functioning measured by the Personal and Social Performance Scale (PSP)

  26. Functioning

    Time frame: 4 months

    Functioning measured by the Personal and Social Performance Scale (PSP)

  27. Functioning

    Time frame: 6 months

    Functioning measured by the Personal and Social Performance Scale (PSP)

  28. Functioning

    Time frame: 9 months

    Functioning measured by the Personal and Social Performance Scale (PSP)

  29. Health-related quality of life (HRQoL)

    Time frame: 3 months

    Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire

  30. Health-related quality of life (HRQoL)

    Time frame: 4 months

    Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire

  31. Health-related quality of life (HRQoL)

    Time frame: 6 months

    Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire

  32. Health-related quality of life (HRQoL)

    Time frame: 9 months

    Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire

  33. Health-related quality of life (HRQoL)

    Time frame: 3 months

    Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.

  34. Health-related quality of life (HRQoL)

    Time frame: 4 months

    Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.

  35. Health-related quality of life (HRQoL)

    Time frame: 6 months

    Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.

  36. Health-related quality of life (HRQoL)

    Time frame: 9 months

    Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire.

  37. Depressive symptoms

    Time frame: 3 months

    Depressive symptoms measured by the Beck Depression Inventory (BDI)

  38. Depressive symptoms

    Time frame: 4 months

    Depressive symptoms measured by the Beck Depression Inventory (BDI)

  39. Depressive symptoms

    Time frame: 6 months

    Depressive symptoms measured by the Beck Depression Inventory (BDI)

  40. Depressive symptoms

    Time frame: 9 months

    Depressive symptoms measured by the Beck Depression Inventory (BDI)

Study contacts

Contact information is provided by the study sponsor or research team.

Naoual MELLOUKI BENDIMRED, PhD

CONTACT

[email protected]

0383925267

William DALFIN, MD

CONTACT

[email protected]

03 83 92 68 22

Sponsors and collaborators

Lead sponsor

Centre Psychothérapique de Nancy

Other

Registry information

Acronym: EM-PREPS

Important dates

Study start
2029
Primary completion
2029
Study completion
2029
First posted
Mar 11, 2025
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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