NCT06801171 A Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders
| NCT ID | NCT06801171 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Cognitive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-04-30 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
SACCO GUILLAUME, Pr, MD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Nice
Frequently Asked Questions
Who can join the NCT06801171 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Cognitive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06801171 currently recruiting?
Yes, NCT06801171 is actively recruiting participants. Contact the research team at lemaire.j@chu-nice.fr for enrollment information.
Where is the NCT06801171 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT06801171 clinical trial?
NCT06801171 is sponsored by Centre Hospitalier Universitaire de Nice. The principal investigator is SACCO GUILLAUME, Pr, MD at Centre Hospitalier Universitaire de Nice. The trial plans to enroll 90 participants.