NCT04720014

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

January 19, 2021

Last Update Submit

September 8, 2021

Conditions

Keywords

ResiliencyFlourishingCoping SkillsStress ReductionHealthy Aging

Outcome Measures

Primary Outcomes (1)

  • SMART-3RP group session attendance

    Percentage of participants who attend ≥6 of 9 sessions

    Post-intervention (week 9)

Secondary Outcomes (1)

  • Resident satisfaction with participation in SMART-3RP intervention

    Post-intervention (week 9)

Study Arms (1)

SMART-3RP Group Intervention

EXPERIMENTAL

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

Behavioral: SMART-3RP Group Intervention

Interventions

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.

SMART-3RP Group Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (15)

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

    PMID: 8379800BACKGROUND
  • 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.

    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.

    PMID: 23352048BACKGROUND
  • 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.

    PMID: 28705870BACKGROUND
  • 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.

    PMID: 31650412BACKGROUND
  • 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.

    PMID: 29773354BACKGROUND
  • 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.

    PMID: 27449066BACKGROUND
  • 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.

    PMID: 28222185BACKGROUND
  • 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.

    PMID: 25607120BACKGROUND
  • 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.

    PMID: 8532986BACKGROUND
  • 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.

    PMID: 15189396BACKGROUND
  • 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.

    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.

    PMID: 15195318BACKGROUND
  • 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.

    PMID: 26092476BACKGROUND
  • 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.

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Lara Traeger, Ph.D

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Single-arm, pre-test/post-test pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 22, 2021

Study Start

March 30, 2021

Primary Completion

September 20, 2021

Study Completion

September 20, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations