Mindfulness to Reduce Loneliness in Older Caregivers

NCT04560088 | Completed Results DMC

• 2 other identifiers: 5296P30AG064103
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Social Isolation; Loneliness

Keywords

Mindfulness; Caregiver; Alzheimer's Disease; Dementia

Outcome Measures

Primary Outcomes (3)

• Five Facet Mindfulness Questionnaire (FFMQ)

  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.

  20 days

• Difficulties in Emotion Regulation Scale (DERS)

  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 a scale of 1 ("almost never \[0-10%\]") to 5 ("almost always \[91-100%\]"). Scores range from 36-180, with higher scores indicating more difficulty in emotion regulation. Data presented is for the total DERS score.

  20 days

• The UCLA 3-Item Loneliness Scale

  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.

  20 days

Study Arms (2)

Mindfulness

EXPERIMENTAL

Mindfulness using an individual mobile health mindfulness-based intervention training. These sessions are intended to act as a general introduction to mindfulness meditation and incorporate techniques such as breath awareness and body scanning.

Behavioral: Mindfulness

Breathing

ACTIVE COMPARATOR

Breathing control intervention will use an individual breathing app. The intervention is designed to be structurally equivalent to the mindfulness-based study intervention on key common factors of psychosocial interventions: (a) the number of sessions, (b) the length of sessions, and (c) delivery format.

Behavioral: Breathing

Interventions

Mindfulness BEHAVIORAL

Mindfulness-based mobile health intervention.

Mindfulness

Breathing BEHAVIORAL

Breathing mobile health intervention.

Breathing

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking.
• Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia.
• Elevated caregiving distress: above population mean (\>11) on 10-item Perceived Stress Scale (PSS-10) and/or at least moderate caregiver strain (score \>= 5) on the Modified Caregiver Strain Index (MCSI).
• Social disconnectedness: UCLA Loneliness Scale: Short Form score of \>6 (except for n=5 in Aim 1 who report feeling socially connected).
• Access to e-mail in order to complete the e-consent module in REDCap which will be used in this study.

You may not qualify if:

• Non-English speaking because our primary community partner agency (Lifespan) cannot currently accommodate non-English speaking clients.
• Modules from the Mini International Neuropsychiatric Exam (MINI) will be used to exclude subjects who have these psychiatric conditions: current non-alcohol psychoactive substance abuse, psychotic disorders (current and lifetime), bipolar disorder, and current mood disorder with psychotic features.
• Those with significant cognitive impairment on a cognitive screening measure at the HARP screening assessment.
• In order to test the effects of developing mindfulness skills in a novice population, those with a regular systematic mindfulness meditation or related mind-body practice (\>2 times per week) will be excluded.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14609, United States

Location

Related Publications (1)

• Gallegos AM, Chapman BP, Kaplan J, Van Orden KA, Heffner KL. A pilot randomized mobile health mindfulness intervention for older adult caregivers of family members with Alzheimer's disease and related dementias. Aging Ment Health. 2025 Dec;29(12):2165-2172. doi: 10.1080/13607863.2025.2506774. Epub 2025 May 28.

  PMID: 40435371 RESULT

MeSH Terms

Conditions

Social Isolation; Alzheimer Disease; Dementia

Interventions

Mindfulness; Respiration

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Autumn Gallegos, PhD
• Organization: University of Rochester Medical Center

autumn_gallegos@urmc.rochester.edu

5852752824

Study Officials

• Autumn Gallegos, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 23, 2020
• Study Start: January 5, 2021
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: July 2, 2025
• Results First Posted: May 9, 2023

Record last verified: 2025-06

Locations

US (1)