Trial Outcomes & Findings for SMART Trial: Intrapersonal and Interpersonal Stigma Reduction (NCT NCT04693416)

Last Updated: 2023-03-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

Immediately before and 2-weeks post-intervention delivery

Results posted on

2023-03-09

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	50	21
Overall Study COMPLETED	37	21
Overall Study NOT COMPLETED	13	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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.
Overall Study Lost to Follow-up	13	0

Baseline Characteristics

SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intrapersonal Stigma Reduction n=50 Participants 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	Interpersonal Stigma Reduction n=21 Participants 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.	Total n=71 Participants Total of all reporting groups
Age, Continuous	42.9 years n=5 Participants	36.3 years n=7 Participants	41.0 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	15 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	6 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	21 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	50 Participants n=5 Participants	21 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	21 participants n=7 Participants	71 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately before and 2-weeks post-intervention delivery

Population: Intrapersonal arm only

Outcome measures

Outcome measures
Measure	Intrapersonal Stigma Reduction n=37 Participants 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
Enacted Stigma (Intrapersonal)	0.730 score on a scale Standard Deviation 3.813

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intrapersonal Stigma Reduction n=37 Participants 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
Anticipated Stigma (Intrapersonal)	0.514 score on a scale Standard Deviation 4.985

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intrapersonal Stigma Reduction n=37 Participants 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
Internalized Stigma (Intrapersonal)	2.324 score on a scale Standard Deviation 4.720

PRIMARY outcome

Timeframe: Pre/post intervention (week 0)

Population: Interpersonal arm only

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).

Outcome measures

Outcome measures
Measure	Intrapersonal Stigma Reduction n=21 Participants 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
Exposure to Drug Users Index Score	-0.476 score on a scale Standard Deviation 1.601

PRIMARY outcome

Timeframe: Pre/post intervention (week 0: post-test immediately followed intervention)

Population: This measure was only given to the Interpersonal arm only.

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.

Outcome measures

Outcome measures
Measure	Intrapersonal Stigma Reduction n=21 Participants 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
Drug Use Stigmatization Scale Score	2.105 score on a scale Standard Deviation 4.345

PRIMARY outcome

Timeframe: Pre/post intervention (week 0: post-test immediately followed intervention)

Population: This measure was only given to the Interpersonal arm only.

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.

Outcome measures

Outcome measures
Measure	Intrapersonal Stigma Reduction n=21 Participants 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
Stigma of Drug Users Scale Score	1.211 score on a scale Standard Deviation 2.323

SECONDARY outcome

Timeframe: 2-weeks post-intervention

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

Outcome measures

Outcome measures
Measure	Intrapersonal Stigma Reduction n=37 Participants 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
Engagement in Treatment	4 Participants

Adverse Events

Intrapersonal Stigma Reduction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Interpersonal Stigma Reduction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Derefinko, PhD

University of Tennessee Health Science Center

Phone: 901-448-2526

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place