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A Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders

Randomized Clinical Trial Testing a Mixed Intervention to Improve Resilience in People Aged Over 60 Years With Neurocognitive Disorders.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06801171
Acronym
RESILIENCE
Enrollment
90
Registered
2025-01-30
Start date
2025-04-30
Completion date
2027-12-01
Last updated
2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Disorder

Keywords

neurocognitive disorder, resilience, mixed intervention

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.

Interventions

OTHERcognitive stimulation

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

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

monocentric interventional study with minimal risks randomized into three parallel groups

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention).Pre interventionComparison 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.

Secondary

MeasureTime frameDescription
Persistence of improvement in resilience over timeThrough study completion, an average of 3 monthsComparison of scores at Resilience Scale for Older Adults (RSOA) at different time points 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.

Countries

France

Contacts

Primary ContactLEMAIRE JUSTINE
lemaire.j@chu-nice.fr3392034778
Backup Contactfoussat valérie
foussat.v@chu-nice.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026