Clinical trial NCT06801171: A Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders
Official title: Randomized Clinical Trial Testing a Mixed Intervention to Improve Resilience in People Aged Over 60 Years With Neurocognitive Disorders.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Disorder
Keywords: neurocognitive disorder
resilience
mixed intervention
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: monocentric interventional study with minimal risks randomized into three parallel groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Subject already practicing meditation and/or yoga and/or Tai Chi
2. Subject currently undergoing psychological therapy (whatever the approach)
3. Subject with a major hearing, visual or motor disability likely to interfere with the proposed interventions or the performance of assessments;
4. 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.)
5. If taking psychotropic treatment, the dose must have been stable for 4 weeks
6. Vulnerable persons are defined in Articles L1121-5 to -8

Primary outcomes:
measure: Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention).
timeFrame: Pre intervention
measure: Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention).
timeFrame: Pre intervention
measure: Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention).
timeFrame: Pre intervention
Secondary outcomes:
measure: Persistence of improvement in resilience over time
timeFrame: Through study completion, an average of 3 months
measure: Persistence of improvement in resilience over time
timeFrame: Through study completion, an average of 3 months
measure: Persistence of improvement in resilience over time
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: SACCO GUILLAUME, Pr, MD
role: PRINCIPAL_INVESTIGATOR
References: