Meditation and Psychophysical Well-Being in Elderly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Pavia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Understanding of the Italian language
Age ≥ 65 years
No cognitive impairment, as measured by the Addenbrooke's Cognitive Examination (ACE-R)
Disqualifiers
Presence of severe mental disorders and/or significant medical conditions
Substance dependence
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness-Based Meditation (Integral Meditation - IM)
BehavioralThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Mindfulness-Based Intervention GroupExperimental treatment 1 intervention
Group B: Waiting-List Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline (T0), post-intervention (6 weeks, T1)Secondary outcomes
1
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.
Time frame
Baseline (T0), post-intervention (6 weeks, T1)2
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.
Time frame
Baseline (T0), post-intervention (6 weeks, T1)3
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.
Time frame
Baseline (T0), post-intervention (6 weeks, T1)4
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
Time frame
Baseline (T0), post-intervention (6 weeks, T1)Sponsors and contacts
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Source ClinicalTrials.gov