Enhancing Resilience in Senior Community Residents
1 other identifier
interventional
288
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable quality-of-life
Started Jun 2022
1 active site
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
CompletedStudy Start
First participant enrolled
June 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2023
CompletedNovember 7, 2023
November 1, 2023
10 months
June 24, 2022
November 3, 2023
Conditions
Keywords
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
EXPERIMENTALResidents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training upon enrollment.
Waitlist Control Group Intervention
ACTIVE COMPARATORResidents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training after the final survey time point.
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.
Eligibility Criteria
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
Related Publications (25)
McEwen BS, Stellar E. Stress and the individual. Mechanisms leading to disease. Arch Intern Med. 1993 Sep 27;153(18):2093-101.
PMID: 8379800BACKGROUNDUN Dept of Economic and Social Affairs, Population Division. Population ageing and development: ten years after Madrid. Population Facts. 2012;No. 2012/4.
BACKGROUNDPark ER, Traeger L, Vranceanu AM, Scult M, Lerner JA, Benson H, Denninger J, Fricchione GL. The development of a patient-centered program based on the relaxation response: the Relaxation Response Resiliency Program (3RP). Psychosomatics. 2013 Mar-Apr;54(2):165-74. doi: 10.1016/j.psym.2012.09.001. Epub 2013 Jan 22.
PMID: 23352048BACKGROUNDVanderWeele TJ. On the promotion of human flourishing. Proc Natl Acad Sci U S A. 2017 Aug 1;114(31):8148-8156. doi: 10.1073/pnas.1702996114. Epub 2017 Jul 13.
PMID: 28705870BACKGROUNDPark ER, Perez GK, Millstein RA, Luberto CM, Traeger L, Proszynski J, Chad-Friedman E, Kuhlthau KA. A Virtual Resiliency Intervention Promoting Resiliency for Parents of Children with Learning and Attentional Disabilities: A Randomized Pilot Trial. Matern Child Health J. 2020 Jan;24(1):39-53. doi: 10.1007/s10995-019-02815-3.
PMID: 31650412BACKGROUNDGonzalez A, Shim M, Mahaffey B, Vranceanu AM, Reffi A, Park ER. The Relaxation Response Resiliency Program (3RP) in Patients with Headache and Musculoskeletal Pain: A Retrospective Analysis of Clinical Data. Pain Manag Nurs. 2019 Feb;20(1):70-74. doi: 10.1016/j.pmn.2018.04.003. Epub 2018 Dec 13.
PMID: 29773354BACKGROUNDVranceanu AM, Riklin E, Merker VL, Macklin EA, Park ER, Plotkin SR. Mind-body therapy via videoconferencing in patients with neurofibromatosis: An RCT. Neurology. 2016 Aug 23;87(8):806-14. doi: 10.1212/WNL.0000000000003005. Epub 2016 Jul 22.
PMID: 27449066BACKGROUNDStahl JE, Dossett ML, LaJoie AS, Denninger JW, Mehta DH, Goldman R, Fricchione GL, Benson H. Relaxation Response and Resiliency Training and Its Effect on Healthcare Resource Utilization. PLoS One. 2015 Oct 13;10(10):e0140212. doi: 10.1371/journal.pone.0140212. eCollection 2015.
PMID: 26461184BACKGROUNDScult M, Haime V, Jacquart J, Takahashi J, Moscowitz B, Webster A, Denninger JW, Mehta DH. A healthy aging program for older adults: effects on self-efficacy and morale. Adv Mind Body Med. 2015 Winter;29(1):26-33.
PMID: 25607120BACKGROUNDNasreddine, Z. (2019). Montreal Cognitive Assessment FAQ, Can the MoCA be administered remotely? Retrieved from https://www.mocatest.org/faq/
BACKGROUNDBrowne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. doi: 10.1002/sim.4780141709.
PMID: 8532986BACKGROUNDLancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
PMID: 15189396BACKGROUNDRounsaville BJ, Carroll KM, Onken LS. A Stage Model of Behavioral Therapies Research: Getting Started and Moving on From Stage I. Clin Psychol Sci Pract. 2001;8(2):133-142. doi:https://doi.org/10.1093/clipsy.8.2.133
BACKGROUNDShih WJ, Ohman-Strickland PA, Lin Y. Analysis of pilot and early phase studies with small sample sizes. Stat Med. 2004 Jun 30;23(12):1827-42. doi: 10.1002/sim.1807.
PMID: 15195318BACKGROUNDWhitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PMID: 26092476BACKGROUNDPark ER, Luberto CM, Chad-Friedman E, Traeger L, Hall DL, Perez GK, Goshe B, Vranceanu AM, Baim M, Denninger Md PhD JW, Fricchione Md G, Benson Md H, Lechner SC. A Comprehensive Resiliency Framework: Theoretical Model, Treatment, and Evaluation. Glob Adv Health Med. 2021 Mar 24;10:21649561211000306. doi: 10.1177/21649561211000306. eCollection 2021.
PMID: 34377598BACKGROUNDWęziak-Białowolska D, McNeely E, VanderWeele T. Flourish Index and Secure Flourish Index - Development and Validation (SSRN Scholarly Paper ID 3145336). Soc Sci Res Netw. 2017.
BACKGROUNDAntoni MH, Lechner SC, Kazi A, Wimberly SR, Sifre T, Urcuyo KR, Phillips K, Gluck S, Carver CS. How stress management improves quality of life after treatment for breast cancer. J Consult Clin Psychol. 2006 Dec;74(6):1143-52. doi: 10.1037/0022-006X.74.6.1152.
PMID: 17154743BACKGROUNDVanderWeele TJ. Measures of community well-being: A template. Int J Community Well-Being. 2019;2(3):253-275. https://doi.org/10.1007/s42413-019-00036-8
BACKGROUNDWatson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PMID: 3397865BACKGROUNDHahn EA, DeWalt DA, Bode RK, Garcia SF, DeVellis RF, Correia H, Cella D; PROMIS Cooperative Group. New English and Spanish social health measures will facilitate evaluating health determinants. Health Psychol. 2014 May;33(5):490-9. doi: 10.1037/hea0000055. Epub 2014 Jan 20.
PMID: 24447188BACKGROUNDKroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.
PMID: 19996233BACKGROUNDChang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The memorial symptom assessment scale short form (MSAS-SF). Cancer. 2000 Sep 1;89(5):1162-71. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y.
PMID: 10964347BACKGROUNDThornton M, Travis SS. Analysis of the reliability of the modified caregiver strain index. J Gerontol B Psychol Sci Soc Sci. 2003 Mar;58(2):S127-32. doi: 10.1093/geronb/58.2.s127.
PMID: 12646602BACKGROUNDWongpakaran T, Wongpakaran N, Intachote-Sakamoto R, Boripuntakul T. The Group Cohesiveness Scale (GCS) for psychiatric inpatients. Perspect Psychiatr Care. 2013 Jan;49(1):58-64. doi: 10.1111/j.1744-6163.2012.00342.x. Epub 2012 Jun 12.
PMID: 23293998BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lara Traeger, PhD
Massachusetts General Hospital
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