A Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders

Официальное название

Randomized Clinical Trial Testing a Mixed Intervention to Improve Resilience in People Aged Over 60 Years With Neurocognitive Disorders.

Обзор

The study aims to test a program combining cognitive behavioral therapy techniques, positive psychology techniques, mindfulness meditation and yoga, in order to improve resilience in patient with minor cognitive disorder. This intervention will be compared to a control group, but also with a group testing another intervention (an intervention that does not improve resilience in the elderly, namely a "cognitive stimulation" intervention) in order to ensure that the effect potentially obtained is not due to the simple management of the participant. The duration of the intervention will be 3 months, with an evaluation directly before and after the intervention. In addition, in order to best evaluate the effectiveness of the interventions over time, two follow-up measurements will be proposed: a measurement one month after the intervention, then a final one three months after the intervention.

Вмешательства

• Другое cognitive stimulation
  12 sessions (one per week for 12 weeks) in group of cognitive stimulation
• Другое mixed intervention
  12 sessions (one per week for 12 weeks) in group of mixte stimulation (yoga, cognitive behavioral therapy, mindfullness meditation, positive psychology)

Первичные конечные точки

• Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention). [Срок оценки: Pre intervention]
• Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention). [Срок оценки: Pre intervention]
• Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention). [Срок оценки: Pre intervention]

Вторичные конечные точки (3)

• Persistence of improvement in resilience over time [Срок оценки: Through study completion, an average of 3 months]
• Persistence of improvement in resilience over time [Срок оценки: Through study completion, an average of 3 months]
• Persistence of improvement in resilience over time [Срок оценки: Through study completion, an average of 3 months]

Критерии участия

Критерии включения

• Man or Woman aged > 60 years
• Have a minor neurocognitive disorder according to the criteria of the DSM 5
• Score of 145 or less on the Wagnild and Young Resilience Scale (RS) (Wagnild, 2009).
• Subject able to read and write French;
• Subject beneficiaries of a social security scheme;
• Ability to understand and sign free and informed consent.

Критерии исключения

• Subject already practicing meditation and/or yoga and/or Tai Chi
• Subject currently undergoing psychological therapy (whatever the approach)
• Subject with a major hearing, visual or motor disability likely to interfere with the proposed interventions or the performance of assessments;
• Presence and/or recent history (within the last 5 years prior to inclusion in the study) of major psychiatric disorders (e.g., schizophrenia, severe depression, addiction, bipolar disorders, psychotic disorders, risk of dissociation, panic attack, generalized anxiety disorder, etc.)
• If taking psychotropic treatment, the dose must have been stable for 4 weeks
• Vulnerable persons are defined in Articles L1121-5 to -8

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• CHU de Nice — Nice

Идентификаторы

NCT: NCT06801171 · 24-AOI-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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