Enhancing Resilience in Senior Community Residents

November 3, 2023 updated by: Lara Traeger, Massachusetts General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMART-3RP Group Intervention
Residents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training upon enrollment.
Behavioral: SMART-3RP Group Intervention

Nine 1.5 hour group sessions focusing on developing:

  1. An understanding of stress physiology and the physiology of the relaxation response;
  2. A regular practice of eliciting the relaxation response; and
  3. 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.
Active Comparator: Waitlist Control Group Intervention
Residents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training after the final survey time point.
Behavioral: SMART-3RP Group Intervention

Nine 1.5 hour group sessions focusing on developing:

  1. An understanding of stress physiology and the physiology of the relaxation response;
  2. A regular practice of eliciting the relaxation response; and
  3. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 weeks
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.
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 weeks
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.
Up to 12 weeks
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.
Up to 12 weeks
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.
Up to 12 weeks
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.
Up to 12 weeks
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.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Lara Traeger, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2022

Primary Completion (Actual)

April 5, 2023

Study Completion (Actual)

April 5, 2023

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021A019096

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on SMART-3RP Group Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe