A Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders (RESILIENCE)

May 2, 2025 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Nice, France, 06003
        • Recruiting
        • CHU de Nice
        • Contact:
          • SACCO Guillaume, Pr, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
group without intervention
Experimental: cognitive stimulation
group with 12 sessions in group of cognitive stimulation
Other: cognitive stimulation
12 sessions (one per week for 12 weeks) in group of cognitive stimulation
Experimental: mixed intervention
group with 12 sessions in group of mixed stimulation (yoga, cognitive behavioral therapy, mindfulness meditation, positive psychology)
Other: mixed intervention
12 sessions (one per week for 12 weeks) in group of mixte stimulation (yoga, cognitive behavioral therapy, mindfullness meditation, positive psychology)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention).
Time Frame: 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.
Pre intervention
Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention).
Time Frame: 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
Pre intervention
Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention).
Time Frame: 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.
Pre intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence of improvement in resilience over time
Time Frame: Through study completion, an average of 3 months

Comparison 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.
Through study completion, an average of 3 months
Persistence of improvement in resilience over time
Time Frame: Through study completion, an average of 3 months

Comparison of scores at Resilience Scale (RS) at different time points 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
Through study completion, an average of 3 months
Persistence of improvement in resilience over time
Time Frame: 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.
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: SACCO GUILLAUME, Pr, MD, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

January 30, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-AOI-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Disorder

Clinical Trials on cognitive stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe