Meditation and Psychophysical Well-Being in Elderly

NCT06872502 | Recruiting

• 1 other identifier: 1Med_b
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness; Psychophysical Well-being

Keywords

mindfulness; elderly; loneliness; social isolation; wellbeing

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline (T0), post-intervention (6 weeks, T1)

• Reduction in Depressive Symptoms

  Baseline (T0), post-intervention (6 weeks, T1)

• Improvement in Well-being and Life Satisfaction

  Baseline (T0), post-intervention (6 weeks, T1)

• Increase in Mindfulness and Emotional Regulation

  Baseline (T0), post-intervention (6 weeks, T1)

• Improvement in Self-Esteem and body appreciation

  Baseline (T0), post-intervention (6 weeks, T1)

Study Arms (2)

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.

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.

Interventions

Mindfulness-Based Meditation (Integral Meditation - IM) BEHAVIORAL

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.

Also known as: Integral Meditation (IM)

Mindfulness-Based Intervention Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

University of Pavia

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Central Study Contacts

Teresa Fazia, PhD

CONTACT

+390382987188; teresa.fazia@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Outcomes Assessor and Data Analyst are blinded to group allocation. The meditation trainer is aware of the group assignment but does not have access to the outcome measures. participants are not blinded to their assigned group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: February 15, 2025
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

IT (1)