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临床试验/NCT04875065
NCT04875065已完成不适用

Healthy Aging Research Program (HARP): Engage Coaching Project for Latinos

University of Rochester2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年1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
10
试验地点
2
主要终点
Change From Baseline in Loneliness at Post Intervention

研究概览

简要总结

This study asks: "what behavioral strategies are needed to help socially disconnected Hispanic/Latino caregivers with significant barriers to increasing connectedness?" This study uses a mixed methods approach to adapt a brief behavioral intervention-Social Engage psychotherapy-for use with socially disconnected Hispanic/Latino caregivers. This study is a single-arm clinical trial of Social Engage psychotherapy. We propose to enroll 10 participants for up to 8 weekly individual Social Engage psychotherapy sessions, over up to 3 months. Subjects will be aged 40 and older, and be caregivers for a community-dwelling family member with ADRD, living with (or in close proximity to) the family member with dementia, experiencing elevated caregiving distress and social disconnectedness.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age ≥ 40 yrs;
  • Hispanic/Latino
  • English or Spanish speaking;
  • Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
  • Endorse elevated caregiving distress as measured by a score of ≥ 11 on the 10-item Perceived Stress Scale (PSS-10) and/or a score of 5 or greater on the Modified Caregiver Strain Index (MCSI);
  • Endorse clinically significant loneliness as measured by a score of ≥ 6 on the UCLA Loneliness Scale: Short Form.
  • Has access to e-mail in order to complete the e-consent module in REDCap which will be used in this study.

排除标准

  • Primary language is not English or Spanish;
  • Recent or current psychosis;
  • Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment;
  • Hearing problems that preclude completion of the intervention.

结局指标

主要结局

Change From Baseline in Loneliness at Post Intervention

时间窗: Baseline and 3 months

The UCLA Loneliness Scale Version 3 will be used to assess self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. However, some individual items must be reverse-coded so that higher total scores reflect greater loneliness (i.e., 1=4, 2=3, 3=2, 4=1). These items (e.g., "How often do you feel there are people you can turn to?") are items 1,5,6,9,10,15,16,19,20. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness). Mean change in total scores (change = baseline intervention scores - post scores) will be reported.

次要结局

  • Change From Baseline in Social Functioning at Post Intervention(Baseline and 3 months)
  • Change From Baseline in Quality of Life: Social Relationships at Post Intervention(Baseline and 3 months)

研究者

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

Caroline Silva

Assistant Professor

University of Rochester

研究点 (2)

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