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| ID | Type | Description | Link |
|---|---|---|---|
| 3R61AT010604-01S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrapersonal Stigma Reduction | Other | Brief intervention for stigma reduction |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen J Derefinko, PhD | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26972790 | Background | 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. | |
| 24592661 | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intrapersonal arm only | Posted | Mean | Standard Deviation | score on a scale | Immediately before and 2-weeks post-intervention delivery |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Derefinko, PhD | University of Tennessee Health Science Center | 901-448-2526 | kderefin@uthsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 10, 2021 | Dec 7, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2022 | Dec 7, 2022 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 21, 2021 | Dec 7, 2022 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D057545 | Social Stigma |
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| Interpersonal Stigma Reduction | Other | Brief intervention for support persons of intrapersonal intervention participants. |
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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) |
| 21767076 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and 2-weeks post-intervention delivery |
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|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and 2-weeks post-intervention delivery |
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| 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). | Interpersonal arm only | Posted | Mean | Standard Deviation | score on a scale | Pre/post intervention (week 0) |
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| 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. | This measure was only given to the Interpersonal arm only. | Posted | Mean | Standard Deviation | score on a scale | Pre/post intervention (week 0: post-test immediately followed intervention) |
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| 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. | This measure was only given to the Interpersonal arm only. | Posted | Mean | Standard Deviation | score on a scale | Pre/post intervention (week 0: post-test immediately followed intervention) |
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| Secondary | Engagement in Treatment | Number of participants in intrapersonal arm who made an appointment for treatment after receiving the intervention. | Posted | Count of Participants | Participants | 2-weeks post-intervention |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D001523 |
| Mental Disorders |