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临床试验/NCT04693416
NCT04693416已完成2 期

SMART Trial: Reducing Stigma Towards Opioid Use Disorder on the Intrapersonal and Interpersonal Levels

University of Tennessee2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2021年3月8日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
71
试验地点
2
主要终点
Enacted Stigma (Intrapersonal)

研究概览

简要总结

The goal of this project is to develop a multicomponent stigma reduction intervention to address intrapersonal (individual) stigma regarding Opioid Use Disorder (OUD). The intervention will address this cost/benefit evaluation among individuals known to face intersecting stigma of OUD and African American race, with treatment elements chosen explicitly to increase the value of treatment using salient forms of reward, and to ease perceived costs through explicit services in an effort to encourage the occurrence of the first treatment visit for OUD.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
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

  • 18 years of age or older
  • Identify as African American, Black, or mixed race
  • Identify as someone with a substance use disorder who is not currently in treatment OR a support person of someone enrolled
  • Access to a telephone for follow-up assessment
  • Reside in the Memphis, TN area

排除标准

  • Unable to understand consent procedures

结局指标

主要结局

Enacted Stigma (Intrapersonal)

时间窗: Immediately before and 2-weeks post-intervention delivery

Change in Enacted Stigma subscore from Substance Use Stigma Mechanisms Scale (SU-SMS) pre- and post-intervention. All responses are given on a 5-point Likert-type scale, with higher scores indicating greater endorsement of substance use stigma. Enacted (6 items) scale can be created by taking the average of the item responses given. Minimum score = 6, Maximum score = 30. Reported mean is the change in these scores (pre score - post score), so a positive number for the mean is a reduction in stigma using average scores from the Enacted Stigma subscore.

Internalized Stigma (Intrapersonal)

时间窗: Immediately before and 2-weeks post-intervention delivery

Change in Internalized Stigma subscore from Substance Use Stigma Mechanisms Scale (SU-SMS) pre- and post-intervention. All responses are given on a 5-point Likert-type scale, with higher scores indicating greater endorsement of substance use stigma. Enacted (6 items) scale can be created by taking the average of the item responses given. Minimum score = 6, Maximum score = 30. Reported mean is the change in these scores (pre score - post score), so a positive number for the mean is a reduction in stigma using average scores from the Internalized Stigma subscore.

Stigma of Drug Users Scale Score

时间窗: Pre/post intervention (week 0: post-test immediately followed intervention)

The Stigma of Drug Users Scale measures stigma. There are 10 items scored on a 5-point likert scale. Higher scores indicate higher stigma. The score is the average of the 10 items (Min score = 1, Max score = 5). The reported mean for this outcome measure is the change in this score pre and post intervention (pre score - post score). A positive mean indicates a reduction in stigma.

Anticipated Stigma (Intrapersonal)

时间窗: Immediately before and 2-weeks post-intervention delivery

Change in Anticipated Stigma subscore from Substance Use Stigma Mechanisms Scale (SU-SMS) pre- and post-intervention. All responses are given on a 5-point Likert-type scale, with higher scores indicating greater endorsement of substance use stigma. Enacted (6 items) scale can be created by taking the average of the item responses given. Minimum score = 6, Maximum score = 30. Reported mean is the change in these scores (pre score - post score), so a positive number for the mean is a reduction in stigma using average scores from the Anticipated Stigma subscore.

Exposure to Drug Users Index Score

时间窗: Pre/post intervention (week 0)

Exposure to drug users index includes questions regarding if a participant has been exposed to a drug user at home, at work, at school, etc. (7 items; No = 0, Yes = 1). Score is total count (min score = 0, max score = 7). Higher scores indicate more exposure to drug users. Reported mean is the change in this score pre and post intervention (post score - pre score).

Drug Use Stigmatization Scale Score

时间窗: Pre/post intervention (week 0: post-test immediately followed intervention)

The Drug Use Stigmatization Scale measures stigma against drug users. The scale contains 7 items scored on a 5-point likert scale with higher scores representing higher stigma. The score is the average score of the seven items. Min score = 1, Max score = 5. Reported mean is the change in these scores (pre score - post score), so a positive number for the mean is a reduction in stigma.

次要结局

  • Engagement in Treatment(2-weeks post-intervention)

研究者

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

Karen Derefinko, PhD

Assistant Professor

University of Tennessee

研究点 (2)

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