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Clinical Trials/NCT05438134
NCT05438134
Completed
Not Applicable

Enhancing Resilience in Senior Living Community Residents: A Randomized Controlled Trial

Massachusetts General Hospital1 site in 1 country288 target enrollmentJune 24, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Massachusetts General Hospital
Enrollment
288
Locations
1
Primary Endpoint
Flourishing: Flourishing Measure (FM)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 24, 2022
End Date
April 5, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lara Traeger

Assistant Professor

Massachusetts General Hospital

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

Outcomes

Primary Outcomes

Flourishing: Flourishing Measure (FM)

Time Frame: Up to 12 weeks

We will investigate longitudinal differences in flourishing between study groups (FM score range 0-10), with higher scores indicating greater flourishing.

Resilience: Current Experiences Scale (CES)

Time Frame: Up to 12 weeks

We will investigate longitudinal differences in resilience between study groups (CES score range 0-115), with higher scores indicating greater resilience.

Secondary Outcomes

  • Psychological distress: Patient Health Questionnaire 4 (PHQ4)(Up to 12 weeks)
  • Community well-being: Community Well Being Survey (CWB)(Up to 12 weeks)
  • Coping self-efficacy: Measure of Current Status - Part A (MOCS-A)(Up to 12 weeks)
  • Positive affect: Positive and Negative Affect Schedule - Positive Subscale (PANAS-POS)(Up to 12 weeks)
  • Physical symptoms: Condensed Memorial Symptom Assessment Scale (CMSAS)(Up to 12 weeks)
  • Social isolation: Patient-Reported Outcomes Measurement Information System - Social Isolation (PROMIS-SI)(Up to 12 weeks)

Study Sites (1)

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