LonelinessNCT06872502
Meditation and Psychophysical Well-Being in Elderly
A study testing Mindfulness-Based Meditation (Integral Meditation - IM) in people with Loneliness and Psychophysical Well-being, run by University of Pavia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Psychophysical Well-being
- What is being tested?
- Mindfulness-Based Meditation (Integral Meditation - IM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Understanding of the Italian language
- Age ≥ 65 years
- No cognitive impairment, as measured by the Addenbrooke's Cognitive Examination (ACE-R)
Who cannot join
- Presence of severe mental disorders and/or significant medical conditions
- Substance dependence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness-based Intervention for Psychophysical Well-Being in the Italian Elderly
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:
Read more
- 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.
Read the 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:
- 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.
- Conditions
- Loneliness, Psychophysical Well-being
- Being tested
- Mindfulness-Based Meditation (Integral Meditation - IM)
- Keywords
- mindfulness, elderly, loneliness, social isolation, wellbeing
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Meditation (Integral Meditation - IM)Behavioural
Also called Integral Meditation (IM)
The intervention consists of 12 in-person mindfulness-based meditation sessions over a period of six weeks, with each session lasting one hour, twice per week. The practice, called Integral Meditation (IM), includes focused breathing, body relaxation, emotional awareness, and acceptance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Intervention Group | Experimental | Participants in this group will undergo a mindfulness-based meditation intervention called Integral Meditation (IM). The intervention consists of 12 in-person sessions over six weeks, with each session lasting one hour, twice per week. The meditation techniques will include focused breathing, body relaxation, emotional awareness, and acceptance exercises. Receives: Behavioral: Mindfulness-Based Meditation (Integral Meditation - IM) |
| Waiting-List Control Group | No intervention | Participants in this group will not receive any intervention during the study period. They will be placed on a waiting list and instructed to refrain from any meditation or mindfulness-based activities until the study is completed. This group serves as a passive control to evaluate the effectiveness of the mindfulness-based intervention by comparing pre- and post-intervention measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Perceived Loneliness
The primary outcome is the change in perceived loneliness as measured by the UCLA Loneliness Scale (Version 3). Scores range from 20 to 80, with higher scores indicating greater loneliness. A significant reduction in scores post-intervention would suggest an improvement in loneliness perception.
Measured: Baseline (T0), post-intervention (6 weeks, T1)
Secondary outcomes (6)
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
we will evaluated changes in social isolation assessed using the Lubben Social Network Scale (LSNS-6), which evaluates the size and frequency of participants' social networks. Higher scores indicate greater social connectivity.
Measured: Baseline (T0), post-intervention (6 weeks, T1)
Reduction in Depressive Symptoms
we will evaluate changes in depression levels assessed using the Geriatric Depression Scale (GDS-15). Higher scores indicate greater depressive symptoms, while a reduction in scores suggests improved mental well-being.
Measured: Baseline (T0), post-intervention (6 weeks, T1)
Improvement in Well-being and Life Satisfaction
We will evaluate subjective well-being and life satisfaction using the Satisfaction with Life Scale (SWLS) questionnaire and the Warwick-Edinburgh Mental Well-Being Scale(WEWBS). Higher scores indicate greater satisfaction with life.
Measured: Baseline (T0), post-intervention (6 weeks, T1)
Increase in Mindfulness and Emotional Regulation
We will evaluate mindfulness levels using the Five Facet Mindfulness Questionnaire (FFMQ) and emotional regulation using the Emotion Regulation Questionnaire (ERQ). Higher scores indicate improved mindfulness and emotion regulation
Measured: Baseline (T0), post-intervention (6 weeks, T1)
Improvement in Self-Esteem and body appreciation
We will evaluate Self-esteem via the Rosenberg Self-Esteem Scale (RSES) and via the Body Appreciation Scale we will assess the level of appreciation towards one's own body. Higher scores indicate greater self-esteem and body appreciation.
Measured: Baseline (T0), post-intervention (6 weeks, T1)
Improvement in Sleep Quality
Using the Pittsburgh Sleep Quality Index (PSQI), we will evaluate subjective sleep quality. Higher scores indicate worse sleep quality, while a reduction in scores suggests improved sleep.
Measured: Baseline (T0), post-intervention (6 weeks, T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start15 Feb 2025
- Primary completion1 Jul 2025
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Fazia, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872502
- Sponsor's protocol ID
- 1Med_b
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Intervention for Psychophysical Well-Being in the Italian Elderly
- ClinicalTrials.gov ID
- NCT06872502
- Acronym / sponsor ID
- 1Med_b
- Conditions
- Loneliness, Psychophysical Well-being
- Keywords
- mindfulness, elderly, loneliness, social isolation, wellbeing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Intervention Group | Experimental | Behavioral: Mindfulness-Based Meditation (Integral Meditation - IM)Participants in this group will undergo a mindfulness-based meditation intervention called Integral Meditation (IM). The intervention consists of 12 in-person sessions over six weeks, with each session lasting one hour, twice per week. The meditation techniques will include focused breathing, body relaxation, emotional awareness, and acceptance exercises. |
| Waiting-List Control Group | No intervention | –Participants in this group will not receive any intervention during the study period. They will be placed on a waiting list and instructed to refrain from any meditation or mindfulness-based activities until the study is completed. This group serves as a passive control to evaluate the effectiveness of the mindfulness-based intervention by comparing pre- and post-intervention measures. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Understanding of the Italian language
- Age ≥ 65 years
- No cognitive impairment, as measured by the Addenbrooke's Cognitive Examination (ACE-R)
Key exclusion criteria (2 listed)
- Presence of severe mental disorders and/or significant medical conditions
- Substance dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Meditation (Integral Meditation - IM)Also: Integral Meditation (IM)The intervention consists of 12 in-person mindfulness-based meditation sessions over a period of six weeks, with each session lasting one hour, twice per week. The practice, called Integral Meditation (IM), includes focused breathing, body relaxation, emotional awareness, and acceptance exercises. | Behavioural | Mindfulness-Based Intervention Group |
Primary outcome
Reduction in Perceived Loneliness
Time frame: Baseline (T0), post-intervention (6 weeks, T1)
The primary outcome is the change in perceived loneliness as measured by the UCLA Loneliness Scale (Version 3). Scores range from 20 to 80, with higher scores indicating greater loneliness. A significant reduction in scores post-intervention would suggest an improvement in loneliness perception.
6 secondary outcomes
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
Time frame: Baseline (T0), post-intervention (6 weeks, T1)
Reduction in Depressive Symptoms
Time frame: Baseline (T0), post-intervention (6 weeks, T1)
Improvement in Well-being and Life Satisfaction
Time frame: Baseline (T0), post-intervention (6 weeks, T1)
Increase in Mindfulness and Emotional Regulation
Time frame: Baseline (T0), post-intervention (6 weeks, T1)
Improvement in Self-Esteem and body appreciation
Time frame: Baseline (T0), post-intervention (6 weeks, T1)
Improvement in Sleep Quality
Time frame: Baseline (T0), post-intervention (6 weeks, T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Meditation (Integral Meditation - IM) in people with Loneliness and Psychophysical Well-being, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Perceived Loneliness (time frame: Baseline (T0), post-intervention (6 weeks, T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.