Enhancing Resilience in Senior Living Community Residents

NCT ID: NCT04720014

Last Updated: 2021-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2021-09-20

Brief Summary

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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.

Detailed Description

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Conditions

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Stress, Psychological Coping Skills

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm, pre-test/post-test pilot study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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SMART-3RP Group Intervention

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

Group Type EXPERIMENTAL

SMART-3RP Group Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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SMART-3RP Group Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erickson Living Management, LLC

UNKNOWN

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lara Traeger

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lara Traeger, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 8379800 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 23352048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28705870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31650412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29773354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27449066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28222185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25607120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8532986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15189396 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 15195318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26092476 (View on PubMed)

Traeger L, Styklunas GM, Park EY, Lee MT, Fricchione G, Park ER. Promoting Resilience and Flourishing Among Older Adult Residents in Community Living: A Feasibility Study. Gerontologist. 2022 Nov 30;62(10):1507-1518. doi: 10.1093/geront/gnac031.

Reference Type DERIVED
PMID: 35235940 (View on PubMed)

Other Identifiers

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2020P002834

Identifier Type: -

Identifier Source: org_study_id

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