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

NCT03552042 | Completed

• 1 other identifier: Ageing01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Change in the Short Physical Performance Battery

  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).

  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 (11)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Counterclockwise Program

EXPERIMENTAL

Subjects will participate in an 6-day Counterclockwise Retreat in a retrofitted physical environment circa 1989, which helps the participant psychologically return to a time before diagnosis to re-experience their younger self. Groups will be composed of 10-12 participants plus 3 research assistants/facilitators. Participants will live during the week as if they were in 1989, talking about 1989 events as if they were in the present, and avoiding talking about post-1989 events. Everybody will be invited to participate in conversations and discussions about 1989 in the present tense (presente). Furniture, posters, music, television, newspapers, and technological instruments will all reflect what was available in 1989. Participants will be told not merely to reminisce about this earlier era, but to "inhabit" life in that era, making a psychological leap to be the person they were at the end of the 1980s.

Behavioral: Counterclockwise program

Active control group

ACTIVE COMPARATOR

Participants in the active control group will follow the same agenda of the Counterclockwise Program group, without the constant reference to 1989. The intervention will take place in the same location of the Counterclockwise Program, without any specific change. Activities will mirror the ones of Counterclockwise Program, but participants will not live as if they were younger. The agenda will be the same, but no mention to 1989 will be done. All discussion activities will refer to present days (e.g., instead of discussing the open of the Berlin Wall, they can discuss Brexit or Trump presidency).

Behavioral: Active control group

No-treatment control group

NO INTERVENTION

Non-treated participants will be assessed with the same timeline followed by the other groups. Participants will receive three coupons, for each assessment after the baseline (at T2, T3, and T4) for a two-night break in a location of their choice (among a selection of commercial services).

Interventions

Counterclockwise program BEHAVIORAL

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.

Counterclockwise Program

Active control group BEHAVIORAL

Participants in the active control group will follow the same agenda of the Counterclockwise Program group, without the constant reference to 1989. The intervention will take place in the same location of the Counterclockwise Program, without any specific change. Activities will mirror the ones of Counterclockwise Program, but participants will not live as if they were younger. The agenda will be the same, but no mention to 1989 will be done. All discussion activities will refer to present days (e.g., instead of discussing the open of the Berlin Wall, they can discuss Brexit or Trump presidency).

Active control group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Harvard University: collaborator

Study Sites (1)

Università Cattolica del Sacro Cuore

Milan, MI, 20123, Italy

Location

Related Publications (1)

• 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.

  PMID: 31289097 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychology

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: June 11, 2018
• Study Start: July 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 30, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

IT (1)