Enhancing Resilience in Senior Living Community Residents

Stress, Psychological Clinical Trial

Official title:

Enhancing Resilience in Senior Living Community Residents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04720014
• Other study ID #: 2020P002834
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: September 20, 2021

Study information

• Verified date: September 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coping Skills
• 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 (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Erickson Living Management, LLC

Country where clinical trial is conducted

United States, 

References & Publications (14)

Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. — View 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. — View 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. — View Citation

McEwen BS, Stellar E. Stress and the individual. Mechanisms leading to disease. Arch Intern Med. 1993 Sep 27;153(18):2093-101. Review. — View 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. — View 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. — View 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.

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.

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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SMART-3RP group session attendance	Percentage of participants who attend =6 of 9 sessions	Post-intervention (week 9)
Secondary	Resident satisfaction with participation in SMART-3RP intervention	Proportion of participants who endorse satisfaction on individual survey items	Post-intervention (week 9)