Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-29 @ 6:46 AM
Study NCT ID:
NCT05438134
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2022-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Resilience in Senior Community Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2022-06-24', 'studyFirstSubmitQcDate': '2022-06-24', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resilience: Current Experiences Scale (CES)', 'timeFrame': 'Up to 12 weeks', 'description': 'We will investigate longitudinal differences in resilience between study groups (CES score range 0-115), with higher scores indicating greater resilience.'}, {'measure': 'Flourishing: Flourishing Measure (FM)', 'timeFrame': 'Up to 12 weeks', 'description': 'We will investigate longitudinal differences in flourishing between study groups (FM score range 0-10), with higher scores indicating greater flourishing.'}], 'secondaryOutcomes': [{'measure': 'Psychological distress: Patient Health Questionnaire 4 (PHQ4)', 'timeFrame': 'Up to 12 weeks', 'description': 'We will investigate longitudinal differences in psychological distress between study groups (PHQ4 score range 0-12), with higher scores indicating greater distress.'}, {'measure': 'Social isolation: Patient-Reported Outcomes Measurement Information System - Social Isolation (PROMIS-SI)', 'timeFrame': 'Up to 12 weeks', 'description': 'We will investigate longitudinal differences in social isolation between study groups (PROMIS-SI score range 4-20), with higher scores indicating greater isolation.'}, {'measure': 'Physical symptoms: Condensed Memorial Symptom Assessment Scale (CMSAS)', 'timeFrame': 'Up to 12 weeks', '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.'}, {'measure': 'Coping self-efficacy: Measure of Current Status - Part A (MOCS-A)', 'timeFrame': 'Up to 12 weeks', '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.'}, {'measure': 'Community well-being: Community Well Being Survey (CWB)', 'timeFrame': 'Up to 12 weeks', '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.'}, {'measure': 'Positive affect: Positive and Negative Affect Schedule - Positive Subscale (PANAS-POS)', 'timeFrame': 'Up to 12 weeks', 'description': 'We will investigate longitudinal differences in positive affect between study groups (PANAS-POS range 10-50), with higher scores indicating greater positive affect.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resiliency', 'Flourishing', 'Coping Skills', 'Stress Reduction', 'Healthy Aging'], 'conditions': ['Quality of Life', 'Stress, Psychological']}, 'referencesModule': {'references': [{'pmid': '8379800', 'type': 'BACKGROUND', 'citation': 'McEwen BS, Stellar E. Stress and the individual. Mechanisms leading to disease. Arch Intern Med. 1993 Sep 27;153(18):2093-101.'}, {'type': '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.'}, {'pmid': '23352048', 'type': 'BACKGROUND', '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.'}, {'pmid': '28705870', 'type': 'BACKGROUND', '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.'}, {'pmid': '31650412', 'type': 'BACKGROUND', '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.'}, {'pmid': '29773354', 'type': 'BACKGROUND', '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.'}, {'pmid': '27449066', 'type': 'BACKGROUND', '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.'}, {'pmid': '26461184', 'type': 'BACKGROUND', '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.'}, {'pmid': '25607120', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'Nasreddine, Z. (2019). Montreal Cognitive Assessment FAQ, Can the MoCA be administered remotely? Retrieved from https://www.mocatest.org/faq/'}, {'pmid': '8532986', 'type': 'BACKGROUND', '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.'}, {'pmid': '15189396', 'type': 'BACKGROUND', '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.'}, {'type': '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'}, {'pmid': '15195318', 'type': 'BACKGROUND', '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.'}, {'pmid': '26092476', 'type': 'BACKGROUND', '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.'}, {'pmid': '34377598', 'type': 'BACKGROUND', '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.'}, {'type': '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.'}, {'pmid': '17154743', 'type': 'BACKGROUND', '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.'}, {'type': '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'}, {'pmid': '3397865', 'type': 'BACKGROUND', '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.'}, {'pmid': '24447188', 'type': 'BACKGROUND', '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.'}, {'pmid': '19996233', 'type': 'BACKGROUND', '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.'}, {'pmid': '10964347', 'type': 'BACKGROUND', '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.'}, {'pmid': '12646602', 'type': 'BACKGROUND', '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.'}, {'pmid': '23293998', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident of an Erickson Senior Living community\n* Currently residing in an Erickson Senior Living apartment home\n* Sufficient English language skills to participate in study procedures\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent\n* Unable or unwilling to participate in in-person group sessions'}, 'identificationModule': {'nctId': 'NCT05438134', 'briefTitle': 'Enhancing Resilience in Senior Community Residents', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Enhancing Resilience in Senior Living Community Residents: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2021A019096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMART-3RP Group Intervention', 'description': 'Residents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training upon enrollment.', 'interventionNames': ['Behavioral: SMART-3RP Group Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist Control Group Intervention', 'description': 'Residents will participate in 9 structured weekly group sessions which incorporates stress management and relaxation training after the final survey time point.', 'interventionNames': ['Behavioral: SMART-3RP Group Intervention']}], 'interventions': [{'name': 'SMART-3RP Group Intervention', 'type': 'BEHAVIORAL', 'description': 'Nine 1.5 hour group sessions focusing on developing:\n\n1. An understanding of stress physiology and the physiology of the relaxation response;\n2. A regular practice of eliciting the relaxation response; and\n3. Cognitive behavioral and positive psychology/resilience skills.\n\nParticipants 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.', 'armGroupLabels': ['SMART-3RP Group Intervention', 'Waitlist Control Group Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Lara Traeger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lara Traeger', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}