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Recruiting Not applicable

A Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders

NCT06801171 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-04-30
Last updated
2025-05-04

Condition(s) studied

Cognitive Disorder

Investigational drug(s) / intervention(s)

cognitive stimulationmixed intervention

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

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

Study 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

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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 Resilience Scale for Older Adults (RSOA) between group control and mixed intervention mixed Questionnaire adapted for older adults to evaluate resilience. The RSOA questionnaire contains 33 questions which consists of four overarching factors and 11 facets. The Intrapersonal factor consists of Perseverance and Determination, Self-Efficacy and Independence, Purpose and Meaning, and Positive Perspective. The Interpersonal factor consists of Sense of Community, Family Support, and Friend/Neighbour Support. The Spiritual factor consists of Faith and Prayer, and the Experiential factor consists of Previous Adversity and Proactivity. Each question is measured using a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) Higher scores indicate a higher resilience.
  • 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 Resilience Scale (RS) between group control and mixed intervention mixed The RS questionnaire contains 25 questions. The items in the resilience scale address different aspects of the ability to cope with difficulties and bounce back. For example, some statements concern the ability to find meaning in stressful situations, to remain hopeful for the future, or to feel supported by those around one. Each question is measured using a 5-point Likert scale from 1 (strongly disagree) to 7(strongly agree) Higher scores indicate a higher resilience
  • 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.

Trial sites (1)

FacilityCityRegionStatus
CHU de Nice Nice France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06801171 on ClinicalTrials.gov ↗ ← All trials in France