A Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders

Not Applicable

Recruiting

• Conditions: Cognitive Disorder

• Registration Number: NCT06801171
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-29
• Study First Posted: 2025-01-30
• Study Start: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2027-05-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention).	Pre intervention	Comparison of scores at Brief-COPE between group control and mixed intervention mixed The Brief-COPE is a self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. Coping" is defined broadly as an effort used to minimise distress associated with negative life experiences.; The questionnaire contains 28 questions. Each question is measured using a 4-point Likert scale from 1 I haven't been doing this at all to 4= I've been doing this a lot Higher scores indicate a better coping.

Secondary Outcome Measures

Name	Time	Method
Persistence of improvement in resilience over time	Through study completion, an average of 3 months	Comparison of scores at Brief-COPE at different time points The Brief-COPE is a self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. Coping" is defined broadly as an effort used to minimise distress associated with negative life experiences.; The questionnaire contains 28 questions. Each question is measured using a 4-point Likert scale from 1 I haven't been doing this at all to 4= I've been doing this a lot; Higher scores indicate a better coping.

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France