A Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders

NCT06801171 | Recruiting

• 1 other identifier: 24-AOI-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Disorder

Keywords

neurocognitive disorder; resilience; mixed intervention

Outcome Measures

Primary Outcomes (3)

• Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any 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.

  Pre intervention

• Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any 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

  Pre intervention

• Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any 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.

  Pre intervention

Secondary Outcomes (3)

• Persistence of improvement in resilience over time

  Through study completion, an average of 3 months

• Persistence of improvement in resilience over time

  Through study completion, an average of 3 months

• Persistence of improvement in resilience over time

  Through study completion, an average of 3 months

Study Arms (3)

control

NO INTERVENTION

group without intervention

cognitive stimulation

EXPERIMENTAL

group with 12 sessions in group of cognitive stimulation

Other: cognitive stimulation

mixed intervention

EXPERIMENTAL

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

Other: mixed intervention

Interventions

cognitive stimulation OTHER

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

cognitive stimulation

mixed intervention OTHER

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

mixed intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or Woman aged \> 60 years
• Have a minor neurocognitive disorder according to the criteria of the DSM 5
• Score of 145 or less on the Wagnild and Young Resilience Scale (RS) (Wagnild, 2009).
• Subject able to read and write French;
• Subject beneficiaries of a social security scheme;
• Ability to understand and sign free and informed consent.

You may not qualify if:

• Subject already practicing meditation and/or yoga and/or Tai Chi
• Subject currently undergoing psychological therapy (whatever the approach)
• Subject with a major hearing, visual or motor disability likely to interfere with the proposed interventions or the performance of assessments;
• If taking psychotropic treatment, the dose must have been stable for 4 weeks
• Vulnerable persons are defined in Articles L1121-5 to -8

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06003, France

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Mental Disorders

Study Officials

• SACCO GUILLAUME, Pr, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LEMAIRE JUSTINE

CONTACT

3392034778; lemaire.j@chu-nice.fr

foussat valérie

CONTACT

foussat.v@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: monocentric interventional study with minimal risks randomized into three parallel groups

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 30, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)