SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

Phase 2

Completed

• Conditions: Opioid Use; Substance Use Disorders; Stigma, Social; Opioid-use Disorder

• Registration Number: NCT04693416
• Lead Sponsor: University of Tennessee

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Study Start: 2021-03-08
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Results First Submitted: 2022-10-27
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-08
• Last Update Submitted: 2023-03-08
• Results First Posted: 2023-03-09
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• 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

Exclusion Criteria

• Unable to understand consent procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Enacted Stigma (Intrapersonal)	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)	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	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)	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Engagement in Treatment	2-weeks post-intervention	Number of participants in intrapersonal arm who made an appointment for treatment after receiving the intervention.

Trial Locations

Locations (1)

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States