SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

Study Overview
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Brief Summary
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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.

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

Conditions
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Stigma, Social, Opioid Use, Opioid-use Disorder, Substance Use Disorders

Intervention / Treatment
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* Other: Intrapersonal Stigma Reduction
* Other: Interpersonal Stigma Reduction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrapersonal Stigma Reduction<br>The intervention will include education about substance use disorders (diagnosis, prognosis, and treatment), goal setting to assist the individual in preparing for change, and decisional balance to assist the individual in measuring the costs and benefits about disclosure of mental health problems and exercises to practice how to disclose. Facilitation of an intake assessment for treatment will be offered (with assistance in making the appointment, getting transportation and childcare, and securing a pro-bono status at a outpatient treatment facility). | Other: Intrapersonal Stigma Reduction<br>* Brief intervention for stigma reduction<br>|
| Experimental: Interpersonal Stigma Reduction<br>The intervention for family members and support persons of enrolled intrapersonal participants will include education about substance use disorders (diagnosis, prognosis, and treatment), stigma reduction, and how to provide support for someone with substance use disorder. | Other: Interpersonal Stigma Reduction<br>* Brief intervention for support persons of intrapersonal intervention participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enacted Stigma (Intrapersonal) | 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. | Immediately before and 2-weeks post-intervention delivery | 
| Anticipated Stigma (Intrapersonal) | 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. | Immediately before and 2-weeks post-intervention delivery | 
| Internalized Stigma (Intrapersonal) | 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. | Immediately before and 2-weeks post-intervention delivery | 
| Exposure to Drug Users Index Score | 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). | Pre/post intervention (week 0) | 
| Drug Use Stigmatization Scale Score | 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. | Pre/post intervention (week 0: post-test immediately followed intervention) | 
| Stigma of Drug Users Scale Score | 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. | Pre/post intervention (week 0: post-test immediately followed intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement in Treatment | Number of participants in intrapersonal arm who made an appointment for treatment after receiving the intervention. | 2-weeks post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid use disorder, substance use disorder, stigma