Mindfulness to Reduce Loneliness in Older Caregivers

June 24, 2025 updated by: Autumn Gallegos, University of Rochester

Mindfulness Training to Reduce Social Isolation and Feelings of Loneliness in Older Caregivers for Family Members With Alzheimer's Disease and Related Dementias

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Social isolation and feelings of loneliness are risk factors for older caregivers for family members with Alzheimer's Disease and Related Dementias (ADRD). Further, social isolation and loneliness place older caregivers at risk of poor health, including increased inflammation, cardiovascular disease, depression, and premature mortality. Interventions to promote social connectedness in older caregivers have the potential to reduce elevated morbidity and premature mortality and buffer the high caregiving burden in this growing but understudied population. Thus, developing effective treatments to reduce social disconnectedness in older adults is essential, but previous behavioral treatment efforts have had limited success. Mindfulness-based interventions may reduce loneliness in older adults, as demonstrated in a randomized controlled trial of an 8-week mindfulness-based stress reduction program. Another recent study demonstrated the efficacy of a smartphone-based mindfulness training for reducing loneliness and increasing social contact in daily life among adults reporting above average stress; however, smartphone-based mindfulness training interventions have not been tested with older adults, nor have they been tested with caregivers of family members with ADRD. Specifically, prior studies were conducted with healthy adults not necessarily burdened by caregiving; it remains unknown how caregiver stress --related to competing demands on time and significant loneliness --may impact the ability to comply with the intervention as well as indicate barriers to efficacy. The current study will follow a similar protocol as the aforementioned randomized controlled trial that used a smartphone-based mindfulness training to address loneliness and social contact.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14609
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Non-English speaking because our primary community partner agency (Lifespan) cannot currently accommodate non-English speaking clients.
  • Current problem drinking will be assessed using the AUDIT-C during the phone screen (score of 5 or greater indicating exclusion).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness
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
Mindfulness-based mobile health intervention.
Active Comparator: Breathing
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
Breathing mobile health intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: 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.
20 days
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: 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 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
Time Frame: 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.
20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Autumn Gallegos, PhD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5296
  • P30AG064103 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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