SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

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

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.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders; Opioid Use; Opioid-use Disorder; Stigma, Social
• Intervention / Treatment: Other: Intrapersonal Stigma Reduction; Other: Interpersonal Stigma Reduction

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrapersonal Stigma Reduction; 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; Brief intervention for stigma reduction
Experimental: Interpersonal Stigma Reduction; 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; Brief intervention for support persons of intrapersonal intervention participants.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Tennessee
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Karen J Derefinko, PhD, University of Tennessee

Publications and helpful links

General Publications

• Smith LR, Earnshaw VA, Copenhaver MM, Cunningham CO. Substance use stigma: Reliability and validity of a theory-based scale for substance-using populations. Drug Alcohol Depend. 2016 May 1;162:34-43. doi: 10.1016/j.drugalcdep.2016.02.019. Epub 2016 Feb 26.
• Palamar JJ. An examination of beliefs and opinions about drug use in relation to personal stigmatization towards drug users. J Psychoactive Drugs. 2013 Nov-Dec;45(5):367-73. doi: 10.1080/02791072.2013.843044.
• Palamar JJ, Kiang MV, Halkitis PN. Development and psychometric evaluation of scales that assess stigma associated with illicit drug users. Subst Use Misuse. 2011;46(12):1457-67. doi: 10.3109/10826084.2011.596606. Epub 2011 Jul 18.

Helpful Links

• Lab website

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: opioid use disorder; stigma; substance use disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Disease; Opioid-Related Disorders
• Other Study ID Numbers: 20-07852; 3R61AT010604-01S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No