Clinical trial NCT03552042: Ageing as a Mindset: A Counterclockwise Experiment to Rejuvenate Older Adults
Official title: Ageing as a Mindset: A Counterclockwise Experiment to Rejuvenate Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Fondazione Don Carlo Gnocchi Onlus
name: Harvard University
First posted: 2018-06-11
Enrollment: 90
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in the Short Physical Performance Battery
timeFrame: 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
Secondary outcomes:
measure: Heart rate
timeFrame: 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
measure: Blood pressure
timeFrame: 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
measure: Oxygen saturation
timeFrame: 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
measure: Respiratory rate
timeFrame: 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
measure: Memory
timeFrame: 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
measure: Attentive function
timeFrame: 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
measure: Psychological well-being
timeFrame: 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
measure: Anxiety
timeFrame: 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
measure: Depression
timeFrame: 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
measure: Ageing stereotypes
timeFrame: 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
measure: Appearance
timeFrame: 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
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Università Cattolica del Sacro Cuore
state: MI
Study officials:
References:
citation: Pagnini F, Cavalera C, Volpato E, Comazzi B, Vailati Riboni F, Valota C, Bercovitz K, Molinari E, Banfi P, Phillips D, Langer E. Ageing as a mindset: a study protocol to rejuvenate older adults with a counterclockwise psychological intervention. BMJ Open. 2019 Jul 9;9(7):e030411. doi: 10.1136/bmjopen-2019-030411.