Clinical trial NCT05438134: Enhancing Resilience in Senior Community Residents
Official title: Enhancing Resilience in Senior Living Community Residents: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Stress, Psychological
Keywords: Resiliency
Flourishing
Coping Skills
Stress Reduction
Healthy Aging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 288
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized waitlist-controlled trial tests the efficacy of the Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP), a mind-body intervention, to enhance resilience and flourishing among residents in continuing care retirement communities. The investigators hypothesize that participants in the SMART-3RP group will report greater increases in resilience and flourishing relative to participants in the control group.

Detailed description: This randomized control trial tests the efficacy of the Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) to improve resilience and flourishing among older adults residing in continuing care retirement communities relative to a wait-list control group. At enrollment, participants will be randomly assigned to the intervention group or the control group using computer generated 1:1 blocked randomization stratified by community site. The intervention group will receive the SMART-3RP program immediately upon enrollment; the wait-list control group will be invited to receive the SMART-3RP program after the final survey time point. An estimate of 360 participants will be recruited from up to nine geographically diverse Erickson Senior Living communities.

Eligibility criteria: Inclusion Criteria:

* Resident of an Erickson Senior Living community
* Currently residing in an Erickson Senior Living apartment home
* Sufficient English language skills to participate in study procedures

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Unable or unwilling to participate in in-person group sessions

Primary outcomes:
measure: Resilience: Current Experiences Scale (CES)
timeFrame: Up to 12 weeks
measure: Flourishing: Flourishing Measure (FM)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Psychological distress: Patient Health Questionnaire 4 (PHQ4)
timeFrame: Up to 12 weeks
measure: Social isolation: Patient-Reported Outcomes Measurement Information System - Social Isolation (PROMIS-SI)
timeFrame: Up to 12 weeks
measure: Physical symptoms: Condensed Memorial Symptom Assessment Scale (CMSAS)
timeFrame: Up to 12 weeks
measure: Coping self-efficacy: Measure of Current Status - Part A (MOCS-A)
timeFrame: Up to 12 weeks
measure: Community well-being: Community Well Being Survey (CWB)
timeFrame: Up to 12 weeks
measure: Positive affect: Positive and Negative Affect Schedule - Positive Subscale (PANAS-POS)
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lara Traeger, PhD
role: PRINCIPAL_INVESTIGATOR
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