Enhancing Resilience in Senior Community Residents

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05438134
• Other study ID #: 2021A019096
• Status: Completed
• Phase: N/A
• Start date: June 24, 2022
• Est. completion date: April 5, 2023

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: April 5, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life
• Stress, Psychological

Intervention

Behavioral:
• SMART-3RP Group Intervention
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resilience: Current Experiences Scale (CES)	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
Primary	Flourishing: Flourishing Measure (FM)	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	Psychological distress: Patient Health Questionnaire 4 (PHQ4)	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
Secondary	Social isolation: Patient-Reported Outcomes Measurement Information System - Social Isolation (PROMIS-SI)	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
Secondary	Physical symptoms: Condensed Memorial Symptom Assessment Scale (CMSAS)	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
Secondary	Coping self-efficacy: Measure of Current Status - Part A (MOCS-A)	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
Secondary	Community well-being: Community Well Being Survey (CWB)	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
Secondary	Positive affect: Positive and Negative Affect Schedule - Positive Subscale (PANAS-POS)	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