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NCT Number: NCT06801171

A Mixed Intervention to Improve Resilience for Patient 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.

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Key information

Conditions

Cognitive Disorder Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06003, France

Location status: Recruiting

Location contact

SACCO Guillaume, Pr, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

cognitive stimulation

Other

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

LEMAIRE JUSTINE

CONTACT

[email protected]

3392034778

foussat valérie

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: RESILIENCE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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