Social IsolationNCT04560088
Mindfulness to Reduce Loneliness in Older Caregivers
A study testing Mindfulness and Breathing in people with Social Isolation and Loneliness, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Social Isolation, Loneliness
- What is being tested?
- Mindfulness and Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 21 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14609
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Isolation, Loneliness
- Being tested
- Mindfulness, Breathing
- Keywords
- Mindfulness, Caregiver, Alzheimer's Disease, Dementia
- Medical subject headings
- Social Isolation, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Mindfulness-based mobile health intervention.
BreathingBehavioural
Breathing mobile health intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start5 Jan 2021
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Autumn Gallegos, University of Rochester
- Investigators
- Autumn Gallegos, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560088
- Sponsor's protocol ID
- 5296
- Other IDs
- P30AG064103
- Status last verified
- Jun 2025
- First submitted
- 11 Sep 2020
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40435371
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training to Reduce Social Isolation and Feelings of Loneliness in Older Caregivers for Family Members With Alzheimer's Disease and Related Dementias
- ClinicalTrials.gov ID
- NCT04560088
- Acronym / sponsor ID
- 5296
- Conditions
- Social Isolation, Loneliness
- Keywords
- Mindfulness, Caregiver, Alzheimer's Disease, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Posted 9 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: MindfulnessMindfulness 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. |
| Breathing | Active comparator | Behavioral: BreathingBreathing 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessMindfulness-based mobile health intervention. | Behavioural | Mindfulness |
| BreathingBreathing mobile health intervention. | Behavioural | Breathing |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40435371Gallegos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Autumn Gallegos, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Breathing in people with Social Isolation and Loneliness, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five Facet Mindfulness Questionnaire (FFMQ) (time frame: 20 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.