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临床试验/NCT05438134
NCT05438134已完成不适用

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

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2022年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
288
试验地点
2
主要终点
Flourishing: Flourishing Measure (FM)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Flourishing: Flourishing Measure (FM)

时间窗: Up to 12 weeks

We will investigate longitudinal differences in flourishing between study groups (FM score range 0-10), with higher scores indicating greater flourishing.

Resilience: Current Experiences Scale (CES)

时间窗: Up to 12 weeks

We will investigate longitudinal differences in resilience between study groups (CES score range 0-115), with higher scores indicating greater resilience.

次要结局

  • Psychological distress: Patient Health Questionnaire 4 (PHQ4)(Up to 12 weeks)
  • Community well-being: Community Well Being Survey (CWB)(Up to 12 weeks)
  • Coping self-efficacy: Measure of Current Status - Part A (MOCS-A)(Up to 12 weeks)
  • Positive affect: Positive and Negative Affect Schedule - Positive Subscale (PANAS-POS)(Up to 12 weeks)
  • Physical symptoms: Condensed Memorial Symptom Assessment Scale (CMSAS)(Up to 12 weeks)
  • Social isolation: Patient-Reported Outcomes Measurement Information System - Social Isolation (PROMIS-SI)(Up to 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lara Traeger

Assistant Professor

Massachusetts General Hospital

研究点 (2)

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