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临床试验/NCT05611060
NCT05611060招募中2 期

Building Healthy Life Skills for Merced County Navigation Center

University of California, Merced2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月10日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
60
试验地点
2
主要终点
Change in stress as assessed by the Perceived Stress Scale, for which averaged rating scores range from 1 to 5 with higher scores reflecting greater stress

研究概览

简要总结

The goal of this intervention trial is to learn test whether participation in the Building Health Life Skills Program leads to improvements in psychological well-being and stress management skills for people who are experiencing homelessness and housing insecurity. The main questions it aims to answer are:

  • Will participation in the Building Healthy Life Skills Program lead to better skills in managing negative emotions?
  • Will participation in the Building Healthy Life Skills Program lead to improvements in psychological well-being, sleep quality, and health-related quality of life?

Participants will be asked to complete three surveys: one prior to the first session of the program, one at the end of the program, and one three months later. The surveys include measures of skills for managing negative emotions, mood states, sleep quality, health-related quality of life, illness experiences, and history of childhood adversity.

详细描述

Community members who are experiencing homelessness and receiving support services from the Merced County Navigation Center and who have enrolled in the center's Building Healthy Life Skills Program will be invited to participate in this intervention evaluation study. The Building Healthy Life Skills program is a 10-week program designed to provide participants with an understanding of how abuse, neglect and household dysfunctions during childhood affect emotional, social, and cognitive well-being; and to provide training in emotion regulation skills, including adaptive emotional processing and expression, mindfulness, and cognitive reappraisal. The sessions are two hours in duration and conducted in classroom style. Open enrollment will be conducted four times a year, serving approximately 60 individuals.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who are receiving support services from the Merced County Navigation Center due their current experiences of housing insecurity or homelessness, and
  • have enrolled in the Building Healthy Life Skills program

排除标准

  • Individuals under the age of 18 years and those who cannot speak English or Spanish

结局指标

主要结局

Change in stress as assessed by the Perceived Stress Scale, for which averaged rating scores range from 1 to 5 with higher scores reflecting greater stress

时间窗: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

Scores on the Perceived Stress Scale

Change in health-related quality of life as assessed by the SF-12, for which scores range from 0 to 100 with higher scores reflecting better quality of life

时间窗: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

Health-related quality of life as assessed by the SF 12

Change in depressive symptoms as assessed by the Center for Epidemiological Studies Depression measure, for which averaged rating scores range from 0 to 3 with higher scores reflecting more depressive symptoms

时间窗: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

Scores on the Center for Epidemiological Studies Depression measure

Change in emotional suppression as assessed by the Cortauld Emotional Control Scale (scores range is 1-4, higher scores reflect higher suppression) and the Emotion Regulation Questionnaire (scores range is 1-5, higher scores reflect higher suppression)

时间窗: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

Scores on the Cortauld Emotional Control Scale and the Emotion Regulation Questionnaire

Change in cognitive reappraisal as an emotion regulation strategy as assessed by the Emotion Regulation Questionnaire, for which averaged rating scores range from 1 to 5 with higher scores reflecting higher use of cognitive reappraisal

时间窗: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

Scores on the Emotion Regulation Questionnaire

Change in rumination as an emotion regulation behavior as assessed by the Rumination and Reflections Questionnaire,for which averaged rating scores range from 1 to t with higher scores reflecting more rumination

时间窗: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

Scores on the Rumination and Reflections Questionnaire

Change in resilience as assessed by the Ego Resilience 89, for which averaged rating scores range from 1 to 5 with higher scores reflecting higher resilience in managing challenging situations

时间窗: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

Scores on the Ego Resilience 89

Change in sleep quality as assessed by the Pittsburgh Sleep Quality Inventory, for which averaged rating scores range from 0 to 21 with higher scores reflecting poorer sleep quality

时间窗: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

Scores on the Pittsburgh Sleep Quality Inventory

Change in mindfulness as an emotional regulation tendency as assessed by the Mindful Awareness Attention Scale, for which averaged rating scores range from 1 to 5 with higher scores reflecting greater mindfulness tendencies

时间窗: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

Scores on the Mindful Awareness Attention Scale

Change in general self-efficacy as assessed by the General Self-Efficacy Survey, for which averaged rating scores range from 1 to 5 with higher scores reflecting higher sense of self-efficacy in managing challenging situations

时间窗: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

Scores on the General Self-Efficacy Survey

Change in physical health as assessed by self-reported number of sick days in the past month (ranging from 0 to 31) and a the frequency of 17 symptoms each rated 1 to 5 and higher averaged rating scores reflecting higher symptom loads

时间窗: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

Scores on a symptom checklist and number of sick days

次要结局

未报告次要终点

研究者

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

Linda Diane Cameron

Professor

University of California, Merced

研究点 (2)

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