A Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cognitive stimulation, mixed intervention.
- Who it may be relevant to
- Registry conditions: Cognitive Disorder. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Clinical Trial Testing a Mixed Intervention to Improve Resilience in People Aged Over 60 Years With Neurocognitive Disorders.
Overview
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.
Interventions
- Other cognitive stimulation
12 sessions (one per week for 12 weeks) in group of cognitive stimulation - Other mixed intervention
12 sessions (one per week for 12 weeks) in group of mixte stimulation (yoga, cognitive behavioral therapy, mindfullness meditation, positive psychology)
Primary outcome measures
- Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention). [Time frame: Pre intervention]
- Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention). [Time frame: Pre intervention]
- Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention). [Time frame: Pre intervention]
Secondary outcome measures (3)
- Persistence of improvement in resilience over time [Time frame: Through study completion, an average of 3 months]
- Persistence of improvement in resilience over time [Time frame: Through study completion, an average of 3 months]
- Persistence of improvement in resilience over time [Time frame: Through study completion, an average of 3 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- CHU de Nice — Nice
Identifiers
NCT: NCT06801171 · 24-AOI-02