Clinical trial NCT06872502: Meditation and Psychophysical Well-Being in Elderly
Official title: Mindfulness-based Intervention for Psychophysical Well-Being in the Italian Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Loneliness
Psychophysical Well-being
Keywords: mindfulness
elderly
loneliness
social isolation
wellbeing
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study involves two groups: one receiving the mindfulness-based intervention and a control group (waiting-list control).

Participants are randomized into these two groups and followed in parallel without switching between conditions.

The outcomes are measured before and after the intervention, comparing the effects between the two groups.
Primary purpose: TREATMENT

Brief summary: The goal of this experimental study is to assess whether a mindfulness-based meditation intervention can reduce loneliness and improve psychophysical well-being in older adults (aged 65 and above).

The main questions it aims to answer are:

* Does the intervention reduce the perception of loneliness in older adults? (primary outcome)
* Does it improve various aspects of psychological well-being, including social isolation, depression, life satisfaction, mindfulness, emotional regulation, self-acceptance, and sleep quality? (secondary outcomes) Researchers will compare the intervention group with a passive control group (waiting-list control) to determine whether the mindfulness-based intervention leads to significant improvements in the measured outcomes.

Participants will:

Complete baseline assessments, including neuropsychological tests and validated questionnaires, before the intervention.

Undergo a 12-session mindfulness-based intervention over 6 weeks, consisting of guided breathing, focused attention, physical relaxation, and emotional awareness exercises.

Complete post-intervention assessments to measure changes in their psychological and physiological well-being.

Detailed description: The aging of the population is now a global phenomenon, and according to the United Nations World Population Prospects 2024, it is estimated that the population over the age of 65 could reach \~24% by the end of this century. Italy ranks as the second country in the world with the highest proportion of elderly citizens. According to recent ISTAT data, individuals over 65 represent \~25% of the total population. This demographic imbalance, strongly skewed toward older age groups, reflects both a low birth rate and increased longevity.

Unfortunately, at least nine million elderly individuals in Italy live alone or are at risk of social isolation. According to data from the "Passi d'Argento" surveillance system of the Italian National Institute of Health (Istituto Superiore di Sanità), this phenomenon affects 1 in 7 people over 65. Social isolation significantly impacts healthy aging, compromising both physical and mental well-being.

Social isolation consists of two components: an objective one and a subjective one, namely loneliness. These two dimensions do not always correlate and affect health through different pathways: the former is more closely linked to physical health, while the latter is primarily associated with mental health.

Several risk factors contribute to this condition (e.g., educational level, environment in which a person was raised, comorbidities, income, etc.), also influencing coping mechanisms. Addressing this social and economic challenge requires timely and sustainable interventions. In this context, mindfulness represents a promising therapeutic and preventive tool.

Mindfulness-based interventions are easily accessible, simple to implement, and have a low economic impact, while promoting both physical and mental health. They foster psychological well-being and personal growth, encouraging a non-judgmental awareness of the present moment. Mindfulness can help older adults accept the changes and losses associated with aging, enhancing self-awareness and developing new coping strategies. Furthermore, mindfulness may serve as a tool to recognize and understand loneliness, potentially transforming it into an opportunity for personal growth.

By promoting active listening, empathy, and self-esteem, mindfulness can also contribute to improving the quality of social relationships. However, studies exploring the effects of mindfulness on loneliness-particularly in older adults-are still limited and often involve small sample sizes and lack comprehensive sociodemographic data.

The objective of this study is to evaluate the impact of a mindfulness-based meditation intervention on the sense of loneliness (primary outcome) as well as on various domains of psychophysical well-being in older adults.

Specifically, the following hypotheses will be tested:

i) The intervention reduces the sense of loneliness (primary outcome); ii) It decreases objective social isolation; iii) It lowers depression levels, contributing to an overall improvement in psychological well-being; iv) It enhances mental well-being and life satisfaction; v) It improves mindfulness and promotes emotional regulation; vi) It fosters greater self-acceptance in terms of body appreciation and enhances self-esteem; vii) It improves sleep quality.

The target population will consist of older adults aged 65 and above, recruited on a voluntary basis.

Eligibility criteria: Inclusion Criteria:

* Understanding of the Italian language
* Age ≥ 65 years
* No cognitive impairment, as measured by the Addenbrooke's Cognitive Examination (ACE-R)

Exclusion Criteria:

* Presence of severe mental disorders and/or significant medical conditions
* Substance dependence

Primary outcomes:
measure: Reduction in Perceived Loneliness
timeFrame: Baseline (T0), post-intervention (6 weeks, T1)
Secondary outcomes:
measure: Reduction in Objective Social Isolation Reduction in Objective Social Isolation Reduction in Objective Social Isolation Reduction in Objective Social Isolation Reduction in Objective Social Isolation
timeFrame: Baseline (T0), post-intervention (6 weeks, T1)
measure: Reduction in Depressive Symptoms
timeFrame: Baseline (T0), post-intervention (6 weeks, T1)
measure: Improvement in Well-being and Life Satisfaction
timeFrame: Baseline (T0), post-intervention (6 weeks, T1)
measure: Increase in Mindfulness and Emotional Regulation
timeFrame: Baseline (T0), post-intervention (6 weeks, T1)
measure: Improvement in Self-Esteem and body appreciation
timeFrame: Baseline (T0), post-intervention (6 weeks, T1)
measure: Improvement in Sleep Quality
timeFrame: Baseline (T0), post-intervention (6 weeks, T1)
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: University of Pavia
Study officials:
References: