AzTrials
AzTrials

Stress, PsychologicalNCT04720014

Enhancing Resilience in Senior Living Community Residents

A study testing SMART-3RP Group Intervention in people with Stress, Psychological and Coping Skills, run by Massachusetts General Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Stress, Psychological, Coping Skills
What is being tested?
SMART-3RP Group Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
30 Mar 2021to 20 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Being tested
SMART-3RP Group Intervention
Keywords
Resiliency, Flourishing, Coping Skills, Stress Reduction, Healthy Aging
Medical subject headings
Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SMART-3RP Group InterventionBehavioural

    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.

Study groups in NCT04720014
Study groupRoleWhat they receive
SMART-3RP Group InterventionExperimentalResidents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training.
Receives: Behavioral: SMART-3RP Group Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SMART-3RP group session attendance

    Percentage of participants who attend ≥6 of 9 sessions

    Measured: Post-intervention (week 9)

Secondary outcomes (1)

  1. Resident satisfaction with participation in SMART-3RP intervention

    Proportion of participants who endorse satisfaction on individual survey items

    Measured: Post-intervention (week 9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start30 Mar 2021
  3. Primary completion20 Sep 2021 (estimated)
  4. Study completion20 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm, pre-test/post-test pilot study
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04720014
Sponsor's protocol ID
2020P002834
Status last verified
Sep 2021
First submitted
19 Jan 2021
Last updated
9 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 8379800

  • 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.

  • 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.

    PubMed 23352048

  • 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.

    PubMed 28705870

  • 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.

    PubMed 31650412

  • 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.

    PubMed 29773354

  • 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.

    PubMed 27449066

  • 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.

    PubMed 28222185

  • 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.

    PubMed 25607120

  • 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.

    PubMed 8532986

  • 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.

    PubMed 15189396

  • 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.

  • 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.

    PubMed 15195318

  • 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.

    PubMed 26092476

  • 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.

    PubMed 35235940

Questions about this trial

What is this clinical trial studying?

A study testing SMART-3RP Group Intervention in people with Stress, Psychological and Coping Skills, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SMART-3RP group session attendance (time frame: Post-intervention (week 9)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04720014, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in