SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

NCT04693416 | Completed Phase 2 Results DMC

• 2 other identifiers: 20-078523R61AT010604-01S1
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

opioid use disorder; substance use disorder; stigma

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Engagement in Treatment

  2-weeks post-intervention

Study Arms (2)

Intrapersonal Stigma Reduction

EXPERIMENTAL

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

Interpersonal Stigma Reduction

EXPERIMENTAL

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

Interventions

Intrapersonal Stigma Reduction OTHER

Brief intervention for stigma reduction

Intrapersonal Stigma Reduction

Interpersonal Stigma Reduction OTHER

Brief intervention for support persons of intrapersonal intervention participants.

Interpersonal Stigma Reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to understand consent procedures

Sponsors & Collaborators

• University of Tennessee: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Related Publications (3)

• 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.

  PMID: 26972790 BACKGROUND

• 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.

  PMID: 24592661 BACKGROUND

• 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.

  PMID: 21767076 BACKGROUND

MeSH Terms

Conditions

Social Stigma; Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Karen Derefinko, PhD
• Organization: University of Tennessee Health Science Center

kderefin@uthsc.edu

901-448-2526

Study Officials

• Karen J Derefinko, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 5, 2021
• Study Start: March 8, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: March 9, 2023
• Results First Posted: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

US (1)