SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

Sponsor
University of Tennessee (Other)
Overall Status
Completed
CT.gov ID
NCT04693416
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH), National Institutes of Health (NIH) (NIH)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intrapersonal Stigma Reduction
  • Other: Interpersonal Stigma Reduction
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
SMART Trial: Reducing Stigma Towards Opioid Use Disorder on the Intrapersonal and Interpersonal Levels
Actual Study Start Date :
Mar 8, 2021
Actual Primary Completion Date :
Aug 30, 2021
Actual Study Completion Date :
Aug 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Stigma reduction [Immediately before and after intervention delivery (week 0)]

    Change in Substance Use Stigma Mechanisms Scale score pre- and post-intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Tennessee Health Science Center Memphis Tennessee United States 38163

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Karen J Derefinko, PhD, University of Tennessee Health Science Center

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Karen Derefinko, PhD, Assistant Professor, University of Tennessee Health Science Center
ClinicalTrials.gov Identifier:
NCT04693416
Other Study ID Numbers:
  • 20-07852
  • 3R61AT010604-01S1
First Posted:
Jan 5, 2021
Last Update Posted:
Mar 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Karen Derefinko, PhD, Assistant Professor, University of Tennessee Health Science Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2022