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临床试验/NCT03552042
NCT03552042已完成不适用

Ageing as a Mindset: A Counterclockwise Experiment to Rejuvenate Older Adults

Catholic University of the Sacred Heart2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Change in the Short Physical Performance Battery

研究概览

简要总结

Ageing is generally perceived as a biologically-determined process. There is growing literature, however, that discusses the role of psychological factors in the ageing process. In particular, age-related stereotypes, which reflect the images that people have about the ageing process, seem to have a strong influence on health and life satisfaction, through self-fulfilling prophecy mechanisms. According to the stereotype embodiment theory, mindful changes in these images will promote a change in both the mind and the body, resulting, for example, in a rejuvenation and in a higher quality of life.

The project aims to investigate whether changes in mindsets (i.e., addressing one's age-related stereotypes) can change the ageing process. The psychological components of ageing, as well as how these could be reverted, will be investigated. In other words, the study aims to provide a first answer to the question: "can the mind be used to become younger?" To answer this question, the project will test the efficacy of an intervention labeled "counterclockwise", based on an original, yet un-replicated, pilot study by Ellen Langer, at Harvard. A group of older adults (aged 75+) will take part of a residential role-play game, in which they will relive their previous self, acting as if they were in the year 1989. The whole residential program, which will last one week, is designed to enhance this perception, including a retrofitted environment and social activities that will prime participants to relive that period.

The counterclockwise intervention will be tested against an active control group and a no-treatment group, with a randomized controlled trial. People in the active control group will spend a week in the same location of the counterclockwise intervention, mirroring the same activities, without any kind of time manipulation. Participants in the no-treatment group will only receive the assessment. Ninety participants will be randomly allocated to one of these three groups. Every participant will be assessed for medical, cognitive, psychological, and age appearance, four times: at the recruitment, after the intervention (i.e., after a week for the no-treatment group), and again after 6 and 12 months.

Expected results will be able to promote a mindset-shift not only in the participants but in the general population. The communication plan, which is integrated into the project plan, includes the presentation of the results to communities and associations of older adults, using the experiment as a proof of concept. It will demonstrate that challenging rigid, culturally driven, age-related stereotypes can result in health and well-being improvement. This is expected to lead to a significant improvement of empowerment and perceived control, with the potential to become viral in social communications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 75 years or older
  • Cognitively preserved, assessed with a Mini Mental State Examination (Folstein, Robins, & Helzer, 1983) score > 18
  • Able to commit the time requested to join the retreat (one full week)
  • Live in Milan (Italy), or close enough to travel to attend the assessments

排除标准

  • Major disability that involves the use of a wheelchair or technological devices (e.g., communication device, invasive or non-invasive ventilation)
  • Recent (<9 months) traumatic events (e.g., death of a close relative, life-threatening events)
  • Traumatic events toward the end of the '80s or the beginning of the '90s

结局指标

主要结局

Change in the Short Physical Performance Battery

时间窗: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up

Physical function will be assessed with the Short Physical Performance Battery (SPPB), a well-established measure of physical function in older adults (Guralnik et al., 1994). It assesses strength, gait, and balance by examining, respectively: (1) time to rise from a chair and return to the seated position five times; (2) time to walk eight feet; and (3) ability to stand with feet together in the side-by-side, semi-tandem, and tandem positions for 10 seconds. Possible scores ranged from 0 to 12, with a higher score indicating better physical performance. Older individuals who receive lower scores on this measure has increased risk of disability, nursing-home placement, and mortality (Levy, et al., 2014; Guralnik et al., 1994).

次要结局

  • Oxygen saturation(Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up)
  • Psychological well-being(Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up)
  • Blood pressure(Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up)
  • Memory(Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up)
  • Heart rate(Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up)
  • Respiratory rate(Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up)
  • Attentive function(Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up)
  • Anxiety(Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up)
  • Ageing stereotypes(Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up)
  • Appearance(Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up)
  • Depression(Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Pagnini

Assistant Professor of Clinical Psychology

Catholic University of the Sacred Heart

研究点 (2)

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