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Quality of LifeNCT05438134

Enhancing Resilience in Senior Community Residents

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Quality of Life, Stress, Psychological
What is being tested?
SMART-3RP Group Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
1 siteUnited States
Study dates
24 Jun 2022to 5 Apr 2023
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 Senior Living community
  • Currently residing in an Erickson Senior 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 in-person group sessions

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Enhancing Resilience in Senior Living Community Residents: A Randomized Controlled Trial

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.

Read the 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.

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 NCT05438134
Study groupRoleWhat they receive
SMART-3RP Group InterventionExperimentalResidents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training upon enrollment.
Receives: Behavioral: SMART-3RP Group Intervention
Waitlist Control Group InterventionActive comparatorResidents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training after the final survey time point.
Receives: Behavioral: SMART-3RP Group Intervention

What is being measured

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

  1. 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.

    Measured: Up to 12 weeks

  2. 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.

    Measured: Up to 12 weeks

Secondary outcomes (6)

  1. 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.

    Measured: Up to 12 weeks

  2. 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.

    Measured: Up to 12 weeks

  3. 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.

    Measured: Up to 12 weeks

  4. 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.

    Measured: Up to 12 weeks

  5. 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.

    Measured: Up to 12 weeks

  6. 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.

    Measured: Up to 12 weeks

Timeline

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

  1. First posted29 Jun 2022
  2. Study start24 Jun 2022
  3. Primary completion5 Apr 2023
  4. Study completion5 Apr 2023

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05438134
Sponsor's protocol ID
2021A019096
Status last verified
Nov 2023
First submitted
24 Jun 2022
Last updated
7 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
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

  • UN Dept of Economic and Social Affairs, Population Division. Population ageing and development: ten years after Madrid. Population Facts. 2012;No. 2012/4.

  • 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. 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.

    PubMed 26461184

  • 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

  • Nasreddine, Z. (2019). Montreal Cognitive Assessment FAQ, Can the MoCA be administered remotely? Retrieved from https://www.mocatest.org/faq/

  • 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, 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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing SMART-3RP Group Intervention in people with Quality of Life and Stress, Psychological, 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: finished, as of the sponsor's last update on 7 Nov 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Resilience: Current Experiences Scale (CES) (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. 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 NCT05438134, which also lists 25 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 7 Nov 2023.

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