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| ID | Type | Description | Link |
|---|---|---|---|
| RIPH 2023-04 | Other Identifier | centre Psychothérapique de Nancy CPN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBTP group | Experimental |
| |
| TAU group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Distress related to psychotic symptoms | Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention | 3 months |
| Distress related to psychotic symptoms | Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention | 4 months |
| Distress related to psychotic symptoms | Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention | 6 months |
| Distress related to psychotic symptoms | Distress related to psychotic symptoms on the CAARMS scale at the end of therapeutic intervention | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of psychotic symptoms | Intensity of psychotic symptoms on the CAARMS scale | 3 months |
| Intensity of psychotic symptoms | Intensity of psychotic symptoms on the CAARMS scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William DALFIN, MD | Contact | 03 83 92 68 22 | William.DALFIN@cpn-laxou.com | |
| Naoual MELLOUKI BENDIMRED, PhD | Contact | 0383925267 | unic@cpn-laxou.com |
| Name | Affiliation | Role |
|---|---|---|
| Vincent Laprevote, PU.PH | Centre Psychothérapique de Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire (CHU) de Brest | Brest | 29200 | France |
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|
| 4 months |
| Intensity of psychotic symptoms | Intensity of psychotic symptoms on the CAARMS scale | 6 months |
| Intensity of psychotic symptoms | Intensity of psychotic symptoms on the CAARMS scale | 9 months |
| Distress related to psychotic symptoms | Distress related to psychotic symptoms on the CAARMS scale | 3 months |
| Distress related to psychotic symptoms | Distress related to psychotic symptoms on the CAARMS scale | 4 months |
| Distress related to psychotic symptoms | Distress related to psychotic symptoms on the CAARMS scale | 6 months |
| Distress related to psychotic symptoms | Distress related to psychotic symptoms on the CAARMS scale | 9 months |
| Number of patients making a transition to psychosis | Number of patients making a transition to psychosis | 3 months |
| Number of patients making a transition to psychosis | Number of patients making a transition to psychosis | 4 months |
| Number of patients making a transition to psychosis | Number of patients making a transition to psychosis | 6 months |
| Number of patients making a transition to psychosis | Number of patients making a transition to psychosis | 9 months |
| Cognitive functions | Cognitive functions measured by the Attentional Performance Tests (APT) | 3 months |
| Cognitive functions | Cognitive functions measured by the Attentional Performance Tests (APT) | 4 months |
| Cognitive functions | Cognitive functions measured by the Attentional Performance Tests (APT) | 6 months |
| Cognitive functions | Cognitive functions measured by the Attentional Performance Tests (APT) | 9 months |
| Cognitive functions | Cognitive functions measured by the California Verbal Learning Test (CVLT) | 3 months |
| Cognitive functions | Cognitive functions measured by the California Verbal Learning Test (CVLT) | 4 months |
| Cognitive functions | Cognitive functions measured by the California Verbal Learning Test (CVLT) | 6 months |
| Cognitive functions | Cognitive functions measured by the California Verbal Learning Test (CVLT) | 9 months |
| Anxiety | Anxiety measured by the State Trait Anxiety Inventory (STAI) | 3 months |
| Anxiety | Anxiety measured by the State Trait Anxiety Inventory (STAI) | 4 months |
| Anxiety | Anxiety measured by the State Trait Anxiety Inventory (STAI) | 6 months |
| Anxiety | Anxiety measured by the State Trait Anxiety Inventory (STAI) | 9 months |
| Functioning | Functioning measured by the Personal and Social Performance Scale (PSP) | 3 months |
| Functioning | Functioning measured by the Personal and Social Performance Scale (PSP) | 4 months |
| Functioning | Functioning measured by the Personal and Social Performance Scale (PSP) | 6 months |
| Functioning | Functioning measured by the Personal and Social Performance Scale (PSP) | 9 months |
| Health-related quality of life (HRQoL) | Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire | 3 months |
| Health-related quality of life (HRQoL) | Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire | 4 months |
| Health-related quality of life (HRQoL) | Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire | 6 months |
| Health-related quality of life (HRQoL) | Health-related quality of life (HRQoL) via the SF-12 (12-Item Short Form Health Survey) questionnaire | 9 months |
| Health-related quality of life (HRQoL) | Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire. | 3 months |
| Health-related quality of life (HRQoL) | Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire. | 4 months |
| Health-related quality of life (HRQoL) | Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire. | 6 months |
| Health-related quality of life (HRQoL) | Health-related quality of life (HRQoL) via MARS (medication adherence) questionnaire. | 9 months |
| Depressive symptoms | Depressive symptoms measured by the Beck Depression Inventory (BDI) | 3 months |
| Depressive symptoms | Depressive symptoms measured by the Beck Depression Inventory (BDI) | 4 months |
| Depressive symptoms | Depressive symptoms measured by the Beck Depression Inventory (BDI) | 6 months |
| Depressive symptoms | Depressive symptoms measured by the Beck Depression Inventory (BDI) | 9 months |
| Centre Psychothérapique de Nancy | Laxou | 54520 | France |
|
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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