Opioid Use, Opioid-use Disorder, Stigma, Social, Substance Use Disorders
Conditions
Keywords
opioid use disorder, substance use disorder, stigma
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.
Interventions
OTHERIntrapersonal Stigma Reduction
Brief intervention for stigma reduction
OTHERInterpersonal Stigma Reduction
Brief intervention for support persons of intrapersonal intervention participants.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
University of Tennessee
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Internalized Stigma (Intrapersonal) | Immediately before and 2-weeks post-intervention delivery | 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. |
| Enacted Stigma (Intrapersonal) | Immediately before and 2-weeks post-intervention delivery | 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) | Immediately before and 2-weeks post-intervention delivery | 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. |
| Stigma of Drug Users Scale Score | Pre/post intervention (week 0: post-test immediately followed intervention) | 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. |
| Exposure to Drug Users Index Score | Pre/post intervention (week 0) | 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 | Pre/post intervention (week 0: post-test immediately followed intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement in Treatment | 2-weeks post-intervention | Number of participants in intrapersonal arm who made an appointment for treatment after receiving the intervention. |
Countries
United States
Participant flow
Recruitment details
Participants in the intrapersonal intervention were recruited from community centers in the target area. Participants in the interpersonal intervention were support persons referred by the participants in the intrapersonal intervention.
Participants by arm
| Arm | Count |
|---|---|
| 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).
Intrapersonal Stigma Reduction: Brief intervention for stigma reduction | 50 |
| 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.
Interpersonal Stigma Reduction: Brief intervention for support persons of intrapersonal intervention participants. | 21 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 0 |
Baseline characteristics
| Characteristic | Intrapersonal Stigma Reduction | Total | Interpersonal Stigma Reduction |
|---|---|---|---|
| Age, Continuous | 42.9 years | 41.0 years | 36.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 71 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 71 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 50 participants | 71 participants | 21 participants |
| Sex: Female, Male Female | 25 Participants | 40 Participants | 15 Participants |
| Sex: Female, Male Male | 25 Participants | 31 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 21 |
| other Total, other adverse events | 0 / 50 | 0 / 21 |
| serious Total, serious adverse events | 0 / 50 | 0 / 21 |
Outcome results
Primary
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.
Time frame: Immediately before and 2-weeks post-intervention delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrapersonal Stigma Reduction | Anticipated Stigma (Intrapersonal) | 0.514 score on a scale | Standard Deviation 4.985 |
Comparison: Pre/post score within armp-value: 0.546t-test, 2 sided
Primary
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.
Time frame: Pre/post intervention (week 0: post-test immediately followed intervention)
Population: This measure was only given to the Interpersonal arm only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrapersonal Stigma Reduction | Drug Use Stigmatization Scale Score | 2.105 score on a scale | Standard Deviation 4.345 |
Comparison: Pre/post score within armp-value: 0.049t-test, 2 sided
Primary
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.
Time frame: Immediately before and 2-weeks post-intervention delivery
Population: Intrapersonal arm only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrapersonal Stigma Reduction | Enacted Stigma (Intrapersonal) | 0.730 score on a scale | Standard Deviation 3.813 |
Comparison: Pre/post scores within armp-value: 0.252t-test, 2 sided
Primary
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).
Time frame: Pre/post intervention (week 0)
Population: Interpersonal arm only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrapersonal Stigma Reduction | Exposure to Drug Users Index Score | -0.476 score on a scale | Standard Deviation 1.601 |
Comparison: Pre/post scores within armp-value: 0.188t-test, 2 sided
Primary
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.
Time frame: Immediately before and 2-weeks post-intervention delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrapersonal Stigma Reduction | Internalized Stigma (Intrapersonal) | 2.324 score on a scale | Standard Deviation 4.72 |
Comparison: Pre/post scores within armp-value: 0.005t-test, 2 sided
Primary
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.
Time frame: Pre/post intervention (week 0: post-test immediately followed intervention)
Population: This measure was only given to the Interpersonal arm only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrapersonal Stigma Reduction | Stigma of Drug Users Scale Score | 1.211 score on a scale | Standard Deviation 2.323 |
Comparison: Pre/post scores within armp-value: 0.036t-test, 2 sided
Secondary
Engagement in Treatment
Number of participants in intrapersonal arm who made an appointment for treatment after receiving the intervention.
Time frame: 2-weeks post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intrapersonal Stigma Reduction | Engagement in Treatment | 4 Participants |