NCT04560088

Mindfulness to Reduce Loneliness in Older Caregivers

Completed NA Results posted Last updated 2 July 2025

What this trial tests

NA trial testing Mindfulness in Social Isolation in 55 participants. Completed in 21 July 2022.

Timeline

5 January 2021

Primary endpoint
21 July 2022

21 July 2022

Quick facts

Lead sponsor	University of Rochester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	55
Start date	5 January 2021
Primary completion	21 July 2022
Estimated completion	21 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness
• Breathing

Conditions studied

• Social Isolation — all drugs for Social Isolation →
• Loneliness — all drugs for Loneliness →

Sponsor

University of Rochester

Who can join

50 and older, any sex, with Social Isolation or Loneliness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Five Facet Mindfulness Questionnaire (FFMQ) Primary · 20 days

The FFMQ assesses five factors that represent mindfulness as it is currently conceptualized: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience, and a total score indicating overall mindfulness. The 39 items of the FFMQ are rated on a 5-point Likert scale, ranging from 1 (never or very rarely true) to 5 (very often or always true). The total score ranges from 39-195, with higher scores indicating greater mindfulness. Data presented is for the total FFMQ score.

Baseline (Time 1)

Group	Value	95% CI
Mindfulness	137.83	± 21.92
Breathing	127.81	± 20.01

Day 20 (Time 2)

Group	Value	95% CI
Mindfulness	137.42	± 20.19
Breathing	134.32	± 21.99

Difficulties in Emotion Regulation Scale (DERS) Primary · 20 days

The DERS is a 36-item self-report measure that assesses emotion dysregulation in six domains: nonacceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. The DERS has demonstrated high internal consistency in clinical and nonclinical samples, good test-retest reliability over 8-weeks, construct validity, and sensitivity to change over time following interventions, including acceptance and mindfulness therapies. Items are rated on

Baseline (Time 1)

Group	Value	95% CI
Mindfulness	67.25	± 17.68
Breathing	86.45	± 25.11

Day 20 (Time 2)

Group	Value	95% CI
Mindfulness	70.32	± 26.85
Breathing	78.19	± 22.67

The UCLA 3-Item Loneliness Scale Primary · 20 days

This assessment has demonstrated excellent internal consistency, test re-test reliability, and construct validity (associations with social support, social network size). Each question is rated on a 3-point scale: 1 = Hardly Ever; 2 = Some of the Time; 3 = Often. All items are summed to give a total score, ranging from 3-9 points. Higher scores indicate more loneliness.

Baseline (Time 1)

Group	Value	95% CI
Mindfulness	6.04	± 1.92
Breathing	7	± 1.73

Day 20 (Time 2)

Group	Value	95% CI
Mindfulness	6.44	± 1.92
Breathing	6.35	± 1.70

Adverse events — posted to ClinicalTrials.gov

Time frame: 20 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mindfulness

Serious: 1/24 (4%)

Deaths: 0/24

Breathing

Serious: 0/31 (0%)

Deaths: 0/31

Serious adverse events (1 terms)

Reaction	System	Mindfulness	Breathing
Interpersonal threat	Social circumstances	—	—

Most-reported serious reactions: Interpersonal threat.

Data from ClinicalTrials.gov NCT04560088 adverse events section.

Sponsor's own description

The objective of this pilot study is to provide initial evidence of the role of mindfulness training in improving social disconnectedness - including social isolation and feelings of loneliness - in older caregivers for family members with ADRD. The investigators propose a two-arm randomized control trial: participants will be randomized to (a) smartphone-based MBSR app (Headspace) or (b) active control (breathing app) for 14 days. Loneliness and quality of social interactions will be assessed using Ecological Momentary Assessment at baseline and 14-days after randomization.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A pilot randomized mobile health mindfulness intervention for older adult caregivers of family members with Alzheimer's disease and related dementias.
   Gallegos AM, Chapman BP, Kaplan J, Van Orden KA, et al · · 2025 · cited 1× · PMID 40435371 · DOI 10.1080/13607863.2025.2506774