Program to enhance resilience in patients with cognitive disorders
Randomized Clinical Trial Testing a Mixed Intervention to Improve Resilience in People Aged Over 60 Years With Neurocognitive Disorders.
This study is testing a program that uses therapy, mindfulness, and yoga to help people with mild cognitive disorders become more resilient and better cope with challenges.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice) |
| Trial ID | NCT06801171 on ClinicalTrials.gov |
What this trial studies
This study tests a program that combines cognitive behavioral therapy, positive psychology, mindfulness meditation, and yoga to improve resilience in patients with minor neurocognitive disorders. Participants will be divided into groups receiving either the mixed intervention or a control intervention that does not enhance resilience. The intervention lasts for three months, with evaluations conducted before and after, as well as follow-up assessments one and three months post-intervention. The goal is to determine the effectiveness of the mixed intervention compared to other approaches.
Who should consider this trial
Good fit: Ideal candidates are individuals over 60 years old with a minor neurocognitive disorder and a resilience score of 145 or less.
Not a fit: Patients currently practicing meditation, yoga, or undergoing psychological therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance the resilience and overall well-being of patients with minor cognitive disorders.
How similar studies have performed: While similar interventions have shown promise in enhancing resilience, this specific combination of techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nice
- CHU de Nice — Nice, France (Recruiting)
Study contacts
- Principal investigator: SACCO GUILLAUME, Pr, MD — Centre Hospitalier Universitaire de Nice
- Study coordinator: Lemaire Justine
- Email: lemaire.j@chu-nice.fr
- Phone: 3392034778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.