A Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders

NCT ID: NCT06801171

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2027-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cognitive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

monocentric interventional study with minimal risks randomized into three parallel groups
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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control

group without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

cognitive stimulation

group with 12 sessions in group of cognitive stimulation

Group Type EXPERIMENTAL

cognitive stimulation

Intervention Type OTHER

12 sessions (one per week for 12 weeks) in group of cognitive stimulation

mixed intervention

group with 12 sessions in group of mixed stimulation (yoga, cognitive behavioral therapy, mindfulness meditation, positive psychology)

Group Type EXPERIMENTAL

mixed intervention

Intervention Type OTHER

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

Interventions

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cognitive stimulation

12 sessions (one per week for 12 weeks) in group of cognitive stimulation

Intervention Type OTHER

mixed intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SACCO GUILLAUME, Pr, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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LEMAIRE JUSTINE

Role: CONTACT

3392034778

foussat valérie

Role: CONTACT

Facility Contacts

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SACCO Guillaume, Pr, MD

Role: primary

Other Identifiers

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24-AOI-02

Identifier Type: -

Identifier Source: org_study_id

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