N/A
N=55
Mindfulness to Reduce Loneliness in Older Caregivers
Social Isolation · Loneliness
Bottom Line
View on ClinicalTrials.gov: NCT04560088 ↗Enrolled (actual)
55
Serious AEs
1.8%
Results posted
May 2023
Primary outcome: Primary: Five Facet Mindfulness Questionnaire (FFMQ) — 137.83; 127.81; 137.42; 134.32 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness (Behavioral); Breathing (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Five Facet Mindfulness Questionnaire (FFMQ) |
137.83; 127.81; 137.42; 134.32 | — |
| PRIMARY Difficulties in Emotion Regulation Scale (DERS) |
67.25; 86.45; 70.32; 78.19 | — |
| PRIMARY The UCLA 3-Item Loneliness Scale |
6.04; 7; 6.44; 6.35 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04560088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.