Clinical Trials Logo

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT04560088
Study type Interventional
Source University of Rochester
Status Completed
Phase N/A
Start date January 5, 2021
Completion date July 21, 2022

See also
  Status Clinical Trial Phase
Completed NCT04164654 - A Mobile App to Address Student Loneliness N/A
Recruiting NCT05831475 - LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation N/A
Completed NCT05490979 - The Impact of Dyad Exercises on Well-being and Connection in Young Adults N/A
Not yet recruiting NCT05054660 - Applying a Chatbot to Geriatric Patients in Psychiatric Clinics: A Pilot Study N/A
Enrolling by invitation NCT04137432 - Oxytocin-augmented Cognitive-behavioral Group-based Short-term Intervention for Loneliness Phase 1
Not yet recruiting NCT05423899 - Humanoid Robot vs Treatment as Usual for Loneliness N/A
Active, not recruiting NCT05678985 - Evaluating Impact and Implementation of Choose to Move (Phase 4) N/A
Withdrawn NCT04797026 - Penpal Loneliness Project N/A
Enrolling by invitation NCT06018974 - Digital Gaming Intervention for Older People in Long-term Care N/A
Recruiting NCT05520450 - Telematic Support Group in Patients With Feelings of Loneliness and Social Isolation
Not yet recruiting NCT05450445 - myHealthHub for Older Adult Inpatients N/A
Active, not recruiting NCT05646329 - The Effect of Motivational Interviewing on Problematic Internet Use and Loneliness N/A
Completed NCT04682535 - Daily Study of Caregiving Relationships and Health
Recruiting NCT04301167 - Loneliness and Health: The Moderating Role of Befriending Services N/A
Completed NCT03124446 - Mindfulness-Based College: Stage 1 N/A
Recruiting NCT04733300 - Online Mindfulness-Based College for Young Adults N/A
Completed NCT04907942 - Feasibility and Acceptability of Click's EMA and Text Message Intervention for STRESS Management Phase 1/Phase 2
Recruiting NCT05812989 - Modifiers and Mechanisms of Loneliness Interventions N/A
Enrolling by invitation NCT05574192 - The Social Engagement Project: Addressing Isolation With Women Affected by Violence N/A
Not yet recruiting NCT06070402 - Use of a Voice Assistant to Improve Mental Health in Older People N/A