Cognitive DisorderRESILIENCENCT06801171
A Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders
A study testing cognitive stimulation and mixed intervention in people with Cognitive Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Disorder
- What is being tested?
- cognitive stimulation and mixed intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- 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.)
- If taking psychotropic treatment, the dose must have been stable for 4 weeks
- Vulnerable persons are defined in Articles L1121-5 to -8
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
foussat valérie contact
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice, 06003
SACCO Guillaume, Pr, MD
About this study
Official title: 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.
Read more
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
- Being tested
- cognitive stimulation, mixed intervention
- Keywords
- neurocognitive disorder, resilience, mixed intervention
- Medical subject headings
- Cognitive Dysfunction, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive stimulationOther
12 sessions (one per week for 12 weeks) in group of cognitive stimulation
mixed interventionOther
12 sessions (one per week for 12 weeks) in group of mixte stimulation (yoga, cognitive behavioral therapy, mindfullness meditation, positive psychology)
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | group without intervention |
| cognitive stimulation | Experimental | group with 12 sessions in group of cognitive stimulation Receives: Other: cognitive stimulation |
| mixed intervention | Experimental | group with 12 sessions in group of mixed stimulation (yoga, cognitive behavioral therapy, mindfulness meditation, positive psychology) Receives: Other: mixed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Pre intervention
Secondary outcomes (3)
Persistence of improvement in resilience over time
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.
Measured: Through study completion, an average of 3 months
Persistence of improvement in resilience over time
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
Measured: Through study completion, an average of 3 months
Persistence of improvement in resilience over time
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.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start30 Apr 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- monocentric interventional study with minimal risks randomized into three parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SACCO GUILLAUME, Pr, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801171
- Sponsor's protocol ID
- 24-AOI-02
- Acronym
- RESILIENCE
- Status last verified
- May 2025
- First submitted
- 17 Jan 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Testing a Mixed Intervention to Improve Resilience in People Aged Over 60 Years With Neurocognitive Disorders.
- ClinicalTrials.gov ID
- NCT06801171
- Acronym / sponsor ID
- RESILIENCE / 24-AOI-02
- Conditions
- Cognitive Disorder
- Keywords
- neurocognitive disorder, resilience, mixed intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- monocentric interventional study with minimal risks randomized into three parallel groups
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –group without intervention |
| cognitive stimulation | Experimental | Other: cognitive stimulationgroup with 12 sessions in group of cognitive stimulation |
| mixed intervention | Experimental | Other: mixed interventiongroup with 12 sessions in group of mixed stimulation (yoga, cognitive behavioral therapy, mindfulness meditation, positive psychology) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
- 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.)
- If taking psychotropic treatment, the dose must have been stable for 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive stimulation12 sessions (one per week for 12 weeks) in group of cognitive stimulation | Other | cognitive stimulation |
| mixed intervention12 sessions (one per week for 12 weeks) in group of mixte stimulation (yoga, cognitive behavioral therapy, mindfullness meditation, positive psychology) | Other | mixed intervention |
Primary outcome
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.
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
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.
3 secondary outcomes
Persistence of improvement in resilience over time
Time frame: 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
Persistence of improvement in resilience over time
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
foussat valérie contact
SACCO GUILLAUME, Pr, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive stimulation and mixed intervention in people with Cognitive Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LEMAIRE JUSTINE (3392034778, lemaire.j@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention). (time frame: Pre intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.