search
Back to results

Enhancing Resilience in Senior Community Residents

Primary Purpose

Quality of Life, Stress, Psychological

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMART-3RP Group Intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Quality of Life focused on measuring Resiliency, Flourishing, Coping Skills, Stress Reduction, Healthy Aging

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SMART-3RP Group Intervention

Waitlist Control Group Intervention

Arm Description

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

Residents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training after the final survey time point.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Psychological distress: Patient Health Questionnaire 4 (PHQ4)
We will investigate longitudinal differences in psychological distress between study groups (PHQ4 score range 0-12), with higher scores indicating greater distress.
Social isolation: Patient-Reported Outcomes Measurement Information System - Social Isolation (PROMIS-SI)
We will investigate longitudinal differences in social isolation between study groups (PROMIS-SI score range 4-20), with higher scores indicating greater isolation.
Physical symptoms: Condensed Memorial Symptom Assessment Scale (CMSAS)
We will investigate longitudinal differences in physical symptom burden between study groups (CMSAS score range 0-48, with higher scores indicating greater symptom burden.
Coping self-efficacy: Measure of Current Status - Part A (MOCS-A)
We will investigate longitudinal differences in coping self-efficacy between study groups (MOCS-A score range 0-52), with higher scores indicating greater self-efficacy.
Community well-being: Community Well Being Survey (CWB)
We will investigate longitudinal differences in community well-being between study groups (CWB range 0-10), with higher scores indicating greater community well-being.
Positive affect: Positive and Negative Affect Schedule - Positive Subscale (PANAS-POS)
We will investigate longitudinal differences in positive affect between study groups (PANAS-POS range 10-50), with higher scores indicating greater positive affect.

Full Information

First Posted
June 24, 2022
Last Updated
December 22, 2022
Sponsor
Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05438134
Brief Title
Enhancing Resilience in Senior Community Residents
Official Title
Enhancing Resilience in Senior Living Community Residents: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 24, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

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 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.
Detailed Description
This randomized control trial tests the efficacy of the Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) to improve resilience and flourishing among older adults residing in continuing care retirement communities relative to a wait-list control group. At enrollment, participants will be randomly assigned to the intervention group or the control group using computer generated 1:1 blocked randomization stratified by community site. The intervention group will receive the SMART-3RP program immediately upon enrollment; the wait-list control group will be invited to receive the SMART-3RP program after the final survey time point. An estimate of 360 participants will be recruited from up to nine geographically diverse Erickson Senior Living communities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Stress, Psychological
Keywords
Resiliency, Flourishing, Coping Skills, Stress Reduction, Healthy Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (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 upon enrollment.
Arm Title
Waitlist Control Group Intervention
Arm Type
Active Comparator
Arm Description
Residents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training after the final survey time point.
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
Resilience: Current Experiences Scale (CES)
Description
We will investigate longitudinal differences in resilience between study groups (CES score range 0-115), with higher scores indicating greater resilience.
Time Frame
Up to 12 weeks
Title
Flourishing: Flourishing Measure (FM)
Description
We will investigate longitudinal differences in flourishing between study groups (FM score range 0-10), with higher scores indicating greater flourishing.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Psychological distress: Patient Health Questionnaire 4 (PHQ4)
Description
We will investigate longitudinal differences in psychological distress between study groups (PHQ4 score range 0-12), with higher scores indicating greater distress.
Time Frame
Up to 12 weeks
Title
Social isolation: Patient-Reported Outcomes Measurement Information System - Social Isolation (PROMIS-SI)
Description
We will investigate longitudinal differences in social isolation between study groups (PROMIS-SI score range 4-20), with higher scores indicating greater isolation.
Time Frame
Up to 12 weeks
Title
Physical symptoms: Condensed Memorial Symptom Assessment Scale (CMSAS)
Description
We will investigate longitudinal differences in physical symptom burden between study groups (CMSAS score range 0-48, with higher scores indicating greater symptom burden.
Time Frame
Up to 12 weeks
Title
Coping self-efficacy: Measure of Current Status - Part A (MOCS-A)
Description
We will investigate longitudinal differences in coping self-efficacy between study groups (MOCS-A score range 0-52), with higher scores indicating greater self-efficacy.
Time Frame
Up to 12 weeks
Title
Community well-being: Community Well Being Survey (CWB)
Description
We will investigate longitudinal differences in community well-being between study groups (CWB range 0-10), with higher scores indicating greater community well-being.
Time Frame
Up to 12 weeks
Title
Positive affect: Positive and Negative Affect Schedule - Positive Subscale (PANAS-POS)
Description
We will investigate longitudinal differences in positive affect between study groups (PANAS-POS range 10-50), with higher scores indicating greater positive affect.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Unable or unwilling to provide informed consent Unable or unwilling to participate in in-person group sessions
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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
UN Dept of Economic and Social Affairs, Population Division. Population ageing and development: ten years after Madrid. Population Facts. 2012;No. 2012/4.
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
26461184
Citation
Stahl 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. Erratum In: PLoS One. 2017 Feb 21;12 (2):e0172874.
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
Citation
Nasreddine, Z. (2019). Montreal Cognitive Assessment FAQ, Can the MoCA be administered remotely? Retrieved from https://www.mocatest.org/faq/
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, 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
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
PubMed Identifier
34377598
Citation
Park 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.
Results Reference
background
Citation
Węziak-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.
Results Reference
background
PubMed Identifier
17154743
Citation
Antoni 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.
Results Reference
background
Citation
VanderWeele 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
Results Reference
background
PubMed Identifier
3397865
Citation
Watson 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.
Results Reference
background
PubMed Identifier
24447188
Citation
Hahn 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.
Results Reference
background
PubMed Identifier
19996233
Citation
Kroenke 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.
Results Reference
background
PubMed Identifier
10964347
Citation
Chang 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.
Results Reference
background
PubMed Identifier
12646602
Citation
Thornton 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.
Results Reference
background
PubMed Identifier
23293998
Citation
Wongpakaran 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.
Results Reference
background

Learn more about this trial

Enhancing Resilience in Senior Community Residents

We'll reach out to this number within 24 hrs