Randomized Clinical Trial Testing a Mixed Intervention to Improve Resilience in People Aged Over 60 Years With Neurocognitive Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
control
group without intervention
cognitive stimulation
group with 12 sessions in group of cognitive stimulation
干预措施: cognitive stimulation (Other)
mixed intervention
group with 12 sessions in group of mixed stimulation (yoga, cognitive behavioral therapy, mindfulness meditation, positive psychology)
干预措施: mixed intervention (Other)
结局指标
主要结局
Improvement of resilience of patients suffering from mild neurocognitive disorder (NCD) compared to a passive control group (without any intervention).
时间窗: 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.
次要结局
- Persistence of improvement in resilience over time(Through study completion, an average of 3 months)