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SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

Primary Purpose

Stigma, Social, Opioid Use, Opioid-use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intrapersonal Stigma Reduction
Interpersonal Stigma Reduction
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stigma, Social focused on measuring opioid use disorder, substance use disorder, stigma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Tennessee Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intrapersonal Stigma Reduction

Interpersonal Stigma Reduction

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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.
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.

Secondary Outcome Measures

Engagement in Treatment
Number of participants in intrapersonal arm who made an appointment for treatment after receiving the intervention.

Full Information

First Posted
December 31, 2020
Last Updated
March 8, 2023
Sponsor
University of Tennessee
Collaborators
National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04693416
Brief Title
SMART Trial: Intrapersonal and Interpersonal Stigma Reduction
Official Title
SMART Trial: Reducing Stigma Towards Opioid Use Disorder on the Intrapersonal and Interpersonal Levels
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee
Collaborators
National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stigma, Social, Opioid Use, Opioid-use Disorder, Substance Use Disorders
Keywords
opioid use disorder, substance use disorder, stigma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrapersonal Stigma Reduction
Arm Type
Experimental
Arm Description
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).
Arm Title
Interpersonal Stigma Reduction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intrapersonal Stigma Reduction
Intervention Description
Brief intervention for stigma reduction
Intervention Type
Other
Intervention Name(s)
Interpersonal Stigma Reduction
Intervention Description
Brief intervention for support persons of intrapersonal intervention participants.
Primary Outcome Measure Information:
Title
Enacted Stigma (Intrapersonal)
Description
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.
Time Frame
Immediately before and 2-weeks post-intervention delivery
Title
Anticipated Stigma (Intrapersonal)
Description
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.
Time Frame
Immediately before and 2-weeks post-intervention delivery
Title
Internalized Stigma (Intrapersonal)
Description
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.
Time Frame
Immediately before and 2-weeks post-intervention delivery
Title
Exposure to Drug Users Index Score
Description
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).
Time Frame
Pre/post intervention (week 0)
Title
Drug Use Stigmatization Scale Score
Description
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.
Time Frame
Pre/post intervention (week 0: post-test immediately followed intervention)
Title
Stigma of Drug Users Scale Score
Description
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.
Time Frame
Pre/post intervention (week 0: post-test immediately followed intervention)
Secondary Outcome Measure Information:
Title
Engagement in Treatment
Description
Number of participants in intrapersonal arm who made an appointment for treatment after receiving the intervention.
Time Frame
2-weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J Derefinko, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
26972790
Citation
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.
Results Reference
background
PubMed Identifier
24592661
Citation
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.
Results Reference
background
PubMed Identifier
21767076
Citation
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.
Results Reference
background
Links:
URL
https://www.getsolidinitiative.org/smart-stigma
Description
Lab website

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SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

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