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Completed

NCT Number: NCT05438134

Enhancing Resilience in Senior Community Residents

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMART-3RP Group Intervention

Behavioral

Nine 1.5 hour group sessions focusing on developing:

  • An understanding of stress physiology and the physiology of the relaxation response;
  • A regular practice of eliciting the relaxation response; and
  • Cognitive behavioral and positive psychology/resilience skills.

Participants receive a copy of the SMART-3RP session manual and audio recorded guided meditations for independent relaxation practice. Participants are encouraged to practice eliciting the relaxation response daily throughout the study, using the audio recordings or other mind body techniques. Participants will use a practice log to track their practice.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Psychological distress: Patient Health Questionnaire 4 (PHQ4)

    Time frame: Up to 12 weeks

    We will investigate longitudinal differences in psychological distress between study groups (PHQ4 score range 0-12), with higher scores indicating greater distress.

  2. Social isolation: Patient-Reported Outcomes Measurement Information System - Social Isolation (PROMIS-SI)

    Time frame: Up to 12 weeks

    We will investigate longitudinal differences in social isolation between study groups (PROMIS-SI score range 4-20), with higher scores indicating greater isolation.

  3. Physical symptoms: Condensed Memorial Symptom Assessment Scale (CMSAS)

    Time frame: Up to 12 weeks

    We will investigate longitudinal differences in physical symptom burden between study groups (CMSAS score range 0-48, with higher scores indicating greater symptom burden.

  4. Coping self-efficacy: Measure of Current Status - Part A (MOCS-A)

    Time frame: Up to 12 weeks

    We will investigate longitudinal differences in coping self-efficacy between study groups (MOCS-A score range 0-52), with higher scores indicating greater self-efficacy.

  5. Community well-being: Community Well Being Survey (CWB)

    Time frame: Up to 12 weeks

    We will investigate longitudinal differences in community well-being between study groups (CWB range 0-10), with higher scores indicating greater community well-being.

  6. Positive affect: Positive and Negative Affect Schedule - Positive Subscale (PANAS-POS)

    Time frame: Up to 12 weeks

    We will investigate longitudinal differences in positive affect between study groups (PANAS-POS range 10-50), with higher scores indicating greater positive affect.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 29, 2022
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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