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临床试验/NCT07488559
NCT07488559招募中不适用

Engage Coaching to Reduce Social Isolation and Loneliness to Prevent Suicide in Later Life

University of Rochester1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年6月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Loneliness

研究概览

简要总结

The purpose of this study is to test whether an individual coaching program helps adults age 60 and older feel more connected to other people in ways that matter to them.

详细描述

The R33 phase is an RCT (S-ENG+eCAU vs. eCAU only; n=120) with follow-up at 8- and 16 weeks to test target engagement and clinical impact. 10 days of ecological momentary assessment (EMA) will be completed at all assessment points. Participants are 120 adults age 60 and older who report clinically significant loneliness and have access to social activities outside the home. EMA will comprehensively assess indices of social connection. Subjects will complete EMA daily following 3 personally-selected times for prompts (to enhance recall and ease of completion of assessments) for 10-days prior to starting study interventions, beginning the day after the baseline visit. Each EMA instance takes approximately 2-5 minutes to complete. Subjects who successfully complete the smartphone assessment protocol at baseline will be randomly assigned to coaching or waitlist control. Study conditions are Engage Coaching (10 individual coaching sessions) over (up to) 4 month or waitlist control (assessments only for 4 months and then coaching is offered). The follow-up assessments include baseline measures and EMA.

研究设计

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

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60 or older
  • Access to social activities outside the home, including through living in senior living communities
  • Clinically-significant loneliness over the prior month.

排除标准

  • Current problem drinking
  • Psychosis
  • Significant cognitive impairment
  • Hearing problems that preclude engagement with S-ENG and research assessors.

研究组 & 干预措施

Engage Coaching

Experimental

Engage Coaching

干预措施: Social Engage Coaching (S-ENG) (Behavioral)

Waitlist Control

No Intervention

Study intervention (coaching) is provided after study completion (assessments)

结局指标

主要结局

Loneliness

时间窗: 8-week follow-up

PROMIS Social Isolation Short Form 4a assessed by Ecological Momentary Assessment (EMA) for 10 days.

Belonging

时间窗: 8-week follow-up

Interpersonal Needs Questionnaire assessed by Ecological Momentary Assessment (EMA) for 10 days.

Time in conversations

时间窗: 8-week follow-up

Self-report of frequency of conversations with others assessed by Ecological Momentary Assessment (EMA) for 10 days.

Time outside the home

时间窗: 8-week follow-up

Self-report of frequency of time outside the home assessed by Ecological Momentary Assessment (EMA) for 10 days.

次要结局

  • Suicide ideation(16-week follow-up)
  • Depression(16-week follow-up)

研究者

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

Kimberly Van Orden

Professor

University of Rochester

研究点 (1)

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