Clinical trial NCT04560088: Mindfulness to Reduce Loneliness in Older Caregivers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Isolation
Loneliness
Keywords: Mindfulness
Caregiver
Alzheimer's Disease
Dementia
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-09-23
Enrollment: 55
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 20 days
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 20 days
measure: The UCLA 3-Item Loneliness Scale
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Autumn Gallegos, PhD
role: PRINCIPAL_INVESTIGATOR
References: