Back to resultsEnhancing Resilience in Senior Living Community Residents
Primary Purpose
Stress, Psychological, Coping Skills
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMART-3RP Group Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Stress, Psychological focused on measuring Resiliency, Flourishing, Coping Skills, Stress Reduction, Healthy Aging
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SMART-3RP Group Intervention
Arm Description
Residents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training.
Outcomes
Primary Outcome Measures
SMART-3RP group session attendance
Percentage of participants who attend ≥6 of 9 sessions
Secondary Outcome Measures
Resident satisfaction with participation in SMART-3RP intervention
Proportion of participants who endorse satisfaction on individual survey items
Full Information
NCT ID
NCT04720014
First Posted
January 19, 2021
Last Updated
September 8, 2021
Sponsor
Massachusetts General Hospital
Collaborators
Erickson Living Management, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04720014
Brief Title
Enhancing Resilience in Senior Living Community Residents
Official Title
Enhancing Resilience in Senior Living Community Residents
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
September 20, 2021 (Anticipated)
Study Completion Date
September 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Erickson Living Management, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Coping Skills
Keywords
Resiliency, Flourishing, Coping Skills, Stress Reduction, Healthy Aging
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm, pre-test/post-test pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMART-3RP Group Intervention
Arm Type
Experimental
Arm Description
Residents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training.
Intervention Type
Behavioral
Intervention Name(s)
SMART-3RP Group Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
SMART-3RP group session attendance
Description
Percentage of participants who attend ≥6 of 9 sessions
Time Frame
Post-intervention (week 9)
Secondary Outcome Measure Information:
Title
Resident satisfaction with participation in SMART-3RP intervention
Description
Proportion of participants who endorse satisfaction on individual survey items
Time Frame
Post-intervention (week 9)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Traeger, Ph.D
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8379800
Citation
McEwen BS, Stellar E. Stress and the individual. Mechanisms leading to disease. Arch Intern Med. 1993 Sep 27;153(18):2093-101.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
23352048
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.
Results Reference
background
PubMed Identifier
28705870
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.
Results Reference
background
PubMed Identifier
31650412
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.
Results Reference
background
PubMed Identifier
29773354
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.
Results Reference
background
PubMed Identifier
27449066
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.
Results Reference
background
PubMed Identifier
28222185
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.
Results Reference
background
PubMed Identifier
25607120
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.
Results Reference
background
PubMed Identifier
8532986
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.
Results Reference
background
PubMed Identifier
15189396
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
15195318
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.
Results Reference
background
PubMed Identifier
26092476
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.
Results Reference
background
Learn more about this trial
Enhancing Resilience in Senior Living Community Residents
We'll reach out to this number within 24 hrs