Clinical trial NCT04720014: Enhancing Resilience in Senior Living Community Residents
Official title: Enhancing Resilience in Senior Living Community Residents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Coping Skills
Keywords: Resiliency
Flourishing
Coping Skills
Stress Reduction
Healthy Aging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Erickson Living Management, LLC
First posted: 2021-01-22
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, pre-test/post-test pilot study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This single-arm pilot study tests the feasibility of integrating the Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP), a mind-body intervention, into senior living residential communities. The investigators hypothesize that the SMART-3RP intervention will be feasible for senior living community residents to attend.


Eligibility criteria: Inclusion Criteria:

* Resident of an Erickson Living senior living community
* Currently residing in an Erickson 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 group sessions

Primary outcomes:
measure: SMART-3RP group session attendance
timeFrame: Post-intervention (week 9)
Secondary outcomes:
measure: Resident satisfaction with participation in SMART-3RP intervention
timeFrame: Post-intervention (week 9)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lara Traeger, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: McEwen BS, Stellar E. Stress and the individual. Mechanisms leading to disease. Arch Intern Med. 1993 Sep 27;153(18):2093-101.
citation: Population ageing and development: ten years after Madrid. Population Facts 2012/4. New York, NY: UN Dept of Economic and Social Affairs, Population Division; 2012. UN Dept of Economic and Social Affairs.
citation: Park 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.
citation: VanderWeele 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.
citation: Park 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.
citation: Gonzalez 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.
citation: Vranceanu 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.
citation: Stahl JE, Dossett ML, LaJoie AS, Denninger JW, Mehta DH, Goldman R, Fricchione GL, Benson H. Correction: Relaxation Response and Resiliency Training and Its Effect on Healthcare Resource Utilization. PLoS One. 2017 Feb 21;12(2):e0172874. doi: 10.1371/journal.pone.0172874. eCollection 2017.
citation: Scult 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.
citation: Browne 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.
citation: Lancaster 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.
citation: Rounsaville BJ, Caroll KM, Onken LS. A stage model of behavioral therapies research: getting started and moving on from stage I. Clin Psychol Sci Pract. 2001;8:133-142.
citation: Shih 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.
citation: Whitehead 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.