Mindfulness to Reduce Loneliness in Older Caregivers

• ClinicalTrials.gov Identifier: NCT04560088
• Recruitment Status: Recruiting
• First Posted: September 23, 2020
• Last Update Posted: December 10, 2021
• Sponsor: University of Rochester
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Autumn Gallegos, University of Rochester

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Social Isolation; Loneliness	Behavioral: Mindfulness; Behavioral: Breathing	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 5, 2021
• Estimated Primary Completion Date: April 1, 2022
• Estimated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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. 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). In addition to considering scores on the five subscales individually, facet scores can be combined to produce an overall mindfulness score. Higher scores indicate greater mindfulness.
2. 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%]"). Higher scores indicate more difficulty in emotion regulation.
3. 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. Higher scores indicate more loneliness.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Autumn M Gallegos Greenwich, PhD; 5852752824; autumn_gallegos@urmc.rochester.edu

Locations

United States, New York

University of Rochester Medical Center; Recruiting

Rochester, New York, United States, 14609

Contact: Autumn M Gallegos, PhD 585-275-2824 autumn_gallegos@urmc.rochester.edu

Sponsors and Collaborators

University of Rochester

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Autumn Gallegos, PhD; University of Rochester

More Information

• Responsible Party: Autumn Gallegos, Assistant Professor of Psychiatry, University of Rochester
• ClinicalTrials.gov Identifier: NCT04560088
• Other Study ID Numbers: 5296; P30AG064103 ( U.S. NIH Grant/Contract )
• First Posted: September 23, 2020
• Last Update Posted: December 10, 2021
• Last Verified: December 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Autumn Gallegos, University of Rochester:

Mindfulness; Caregiver; Alzheimer's Disease; Dementia