NCT05438134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 24, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

June 24, 2022

Last Update Submit

November 3, 2023

Conditions

Keywords

ResiliencyFlourishingCoping SkillsStress ReductionHealthy Aging

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Psychological distress: Patient Health Questionnaire 4 (PHQ4)

    Up to 12 weeks

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

    Up to 12 weeks

  • Physical symptoms: Condensed Memorial Symptom Assessment Scale (CMSAS)

    Up to 12 weeks

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

    Up to 12 weeks

  • Community well-being: Community Well Being Survey (CWB)

    Up to 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

SMART-3RP Group Intervention

EXPERIMENTAL

Residents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training upon enrollment.

Behavioral: SMART-3RP Group Intervention

Waitlist Control Group Intervention

ACTIVE COMPARATOR

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

Interventions

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.

SMART-3RP Group InterventionWaitlist Control Group Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (25)

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MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Lara Traeger, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 24, 2022

First Posted

June 29, 2022

Study Start

June 24, 2022

Primary Completion

April 5, 2023

Study Completion

April 5, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations