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Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs

Determining the Feasibility and Acceptability of a Novel Stigma Resistance Text Message Intervention for People Who Use Drugs

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06281548
Enrollment
30
Registered
2024-02-28
Start date
2024-02-29
Completion date
2024-04-14
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stigma, Social, Substance Use

Keywords

people who use drugs, rural health, stigma, behavioral interventions, mobile health, mental health

Brief summary

Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. This study is a single-group pilot trial to determine whether the intervention is feasible and acceptable to participants. All participants will receive the intervention. The primary outcomes are changes in stigma resistance and self-stigma from baseline to 4-week follow-up using self-report. Implementation and process outcomes will be measured to inform future intervention refinement.

Detailed description

Nearly 850,000 Americans have died from overdose in the past two decades, and mortality reached an all-time high during the COVID-19 pandemic. Substance use disorders (SUD) are more highly stigmatized than other health conditions (e.g., HIV, mental illness). SUD stigma prevents uptake of treatment and harm reduction among people who use drugs (PWUD), contributing to needless morbidity (e.g., infectious disease) and mortality (e.g., overdose), and explains in part why only 6.5% of Americans with SUD received past year treatment. Though key federal agencies have identified stigma as a strategic priority in the epidemic, little is known about how to conceptualize and address SUD stigma compared with other health conditions. Strategies to address SUD self-stigma, in particular, are severely lacking. Self-stigma manifests in PWUD as internalized stereotypes and fear of experienced stigma, leading to the so-called 'why try' phenomenon in which the stigmatized are disempowered from pursuing life goals. SUD self-stigma is associated with numerous psychosocial outcomes including depression, anxiety, diminished quality of life, maladaptive coping and leads to delays in treatment and harm reduction seeking and retention. To date, SUD interventions have overwhelmingly targeted public stigma such as treatment provider attitudes, while there is a remarkable dearth of evidence-based interventions for addressing self-stigma in PWUD. Stigma resistance, a coping strategy that promotes resilience through empowerment and positive identity formation, is a promising approach to reducing self-stigma. Stigma resistance is associated with multiple psychosocial outcomes, including reductions in self-stigma and improvements in quality of life, self-efficacy, hope, help-seeking, and recovery. Stigma resistance includes both cognitive and behavioral strategies, such as catching and challenging stigmatizing thoughts, forming positive alternative identities, and empowering oneself through learning about substance use. These strategies align directly with techniques used in the HIV/AIDS and mental illness self-stigma intervention literature. Stigma resistance thus serves as an ideal conceptual framework and menu of strategies for the present study's self-stigma reduction intervention. Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. The specific aim of this study is to evaluate feasibility, acceptability, and preliminary effectiveness of the text message intervention to increase stigma resistance and reduce self-stigma. We will conduct a single-group pilot trial of the intervention among 30 rural Ohio PWUD in active use and collect quantitative and qualitative data at baseline and four-week follow-up.

Interventions

BEHAVIORALRESTART

Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages address the four components of the personal level of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. Content is informed by evidence-based psychotherapeutic approaches (e.g., Acceptance and Commitment Therapy) and health communication theory (e.g., Elaboration Likelihood Model). Messages include psychoeducation about substance use and stigma, coping advice, and suggestions for how to set personal goals, identify values, and build self-esteem.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
NA
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

* Ages 18 and older at enrollment * Residing in Scioto County, Ohio at time of enrollment * Able to speak and read English * Reliable daily access to smart phone with a data plan capable of sending and receiving text messages during the intervention period (4 weeks) * Self-reported past 30-day use of illicit opioids (e.g., heroin, fentanyl), prescription opioids not as prescribed (e.g., oxycodone, buprenorphine), methamphetamine, or cocaine * Willing to provide informed consent

Exclusion criteria

* Unable to be consented due to cognitive impairment * Planning to move out of the study area during the study period * Unwilling or unable to comply with protocol requirements * Currently incarcerated in a correctional facility

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Read Messages Daily (Feasibility - User)4-week follow-up visitPercentage of participants who respond As soon as I saw them or Later that day to the 5-point Likert-type survey question On average, when would you read the text message you received?
Percentage of Participants With Cell Phone Device Challenges (Feasibility - User)4-week follow-up visitPercentage of participants who respond yes to the binary survey question Between the start of the program and now, did you experience any challenges or changes with your phone (e.g., lost, broken) that prevented you from receiving or reading text messages?
Percentage of Participants With Cell Phone Plan Challenges (Feasibility - User)4-week follow-up visitPercentage of participants who respond yes to the binary survey question Between the start of the program and now, did you experience any challenges or changes with your phone number or phone plan (e.g., changed number, ran out of minutes) that prevented you from receiving or reading text messages?
Change in Stigma Resistance Scale (SRS) ScoreBaseline, 4-week follow-up visitThis is a 20-item Likert-type scale that assesses participants' capacity to resist stigma in five domains (self-other differentiation, personal identity, personal cognitions, peer stigma resistance, public stigma resistance). All items are scored such that higher scores reflect greater stigma resistance. Total scale score ranges from 20-100.
Change in Substance Abuse Self-Stigma Scale (SASSS) ScoreBaseline, 4-week follow-up visitThis is a 40-item Likert-type scale that assesses degree to which participants internalize judgment for their substance use and fear experiencing stigma from others. The scale includes four subscales: self-devaluation (8 items), fear of enacted stigma (9 items), stigma avoidance (13 items), and values disengagement (10 items). Total scale score ranges from 40-200, where higher scores reflect higher levels of self-stigma. The self-devaluation, fear of enacted stigma, and stigma avoidance subscales are scored normally, while the values disengagement subscale is reverse scored.
Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment)From first recruitment visit to last recruitment visit (up to 4 weeks)Percentage of potential participants screened for study eligibility who are eligible for participation.
Percentage of Prospective Participants Recruited Into Study (Feasibility - Enrollment)From first recruitment visit to last enrollment visit (up to 4 weeks)Percentage of potential participants screened for study eligibility who enroll in the study.
Time to Sample Saturation (Feasibility - Recruitment)From first recruitment visit to last enrollment visit (up to 4 weeks)Time in days to enroll the full sample size (n=30), starting from the first recruitment visit
Percentage of Participants Retained in Study (Feasibility - Retention)From first enrollment visit to study completion date (up to 8 weeks)Percentage of participants enrolled in the study who are retained through study completion (i.e., complete 4-week follow-up survey).
Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User)4-week follow-up visitThis is a 16-item Likert-type questionnaire designed to assess acceptability of the intervention from the participants' perspective along the eight dimensions of the Theoretical Framework of Acceptability: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self-efficacy, and general acceptability. Total score ranges from 16-64, with higher scores indicating greater acceptability of the intervention.
Percentage of Participants With High Text Message Frequency (Feasibility - User)4-week follow-up visitPercentage of participants who report every day to the 5-point Likert-type survey question Before the start of this program, how often did you send or receive text messages?
Percentage of Participants With High Text Messaging Comfort (Feasibility - User)4-week follow-up visitPercentage of participants who report very comfortable or comfortable to the 5-point Likert-type survey question Before the start of this program, how comfortable were you with sending or receiving text messages?

Secondary

MeasureTime frameDescription
Change in Rosenberg Self-Esteem Scale ScoreBaseline, 4-week follow-up visitThis is a 10-item Likert-type scale that assesses participants' self-esteem. Total scale score range from 10-40, where higher scores indicate greater self-esteem.
Change in Adult Dispositional Hope Scale ScoreBaseline, 4-week follow-up visitThis is a 12-item Likert-type scale that assesses participants' hope (i.e., positive attitude toward the future). Total scale score ranges from 12-96, where higher scores indicate greater hope.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention Arm
Participants in the intervention arm will receive 56 text messages over 4-weeks. RESTART: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages address the four components of the personal level of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. Content is informed by evidence-based psychotherapeutic approaches (e.g., Acceptance and Commitment Therapy) and health communication theory (e.g., Elaboration Likelihood Model). Messages include psychoeducation about substance use and stigma, coping advice, and suggestions for how to set personal goals, identify values, and build self-esteem.
30
Total30

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up3

Baseline characteristics

CharacteristicIntervention Arm
Adult Dispositional Hope Scale43.8 units on a scale
STANDARD_DEVIATION 10.1
Age, Continuous37.3 years
STANDARD_DEVIATION 8.7
Educational Attainment
Associates degree, trade or technical school
0 Participants
Educational Attainment
Bachelors degree, other 4 year college degree, or higher
1 Participants
Educational Attainment
High school diploma or GED
15 Participants
Educational Attainment
Less than high school diploma
4 Participants
Educational Attainment
Some college but no degree
10 Participants
Employment Status
Not in the labor force
2 Participants
Employment Status
Unemployed
22 Participants
Employment Status
Working - full-time
3 Participants
Employment Status
Working - part-time
3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
27 Participants
Region of Enrollment
United States
30 Participants
Rosenberg Self-Esteem Scale23.5 units on a scale
STANDARD_DEVIATION 4.5
Sex/Gender, Customized
Gender
Men
13 Participants
Sex/Gender, Customized
Gender
Non-binary / third gender
0 Participants
Sex/Gender, Customized
Gender
Women
17 Participants
Stigma Resistance Scale74.7 units on a scale
STANDARD_DEVIATION 12.8
Substance Abuse Self-Stigma Scale124.7 units on a scale
STANDARD_DEVIATION 21.2

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 30
other
Total, other adverse events
0 / 30
serious
Total, serious adverse events
0 / 30

Outcome results

Primary

Change in Stigma Resistance Scale (SRS) Score

This is a 20-item Likert-type scale that assesses participants' capacity to resist stigma in five domains (self-other differentiation, personal identity, personal cognitions, peer stigma resistance, public stigma resistance). All items are scored such that higher scores reflect greater stigma resistance. Total scale score ranges from 20-100.

Time frame: Baseline, 4-week follow-up visit

Population: Includes participants not lost-to-follow-up with complete data.

ArmMeasureValue (MEAN)
Intervention ArmChange in Stigma Resistance Scale (SRS) Score6.28 score on a scale
Primary

Change in Substance Abuse Self-Stigma Scale (SASSS) Score

This is a 40-item Likert-type scale that assesses degree to which participants internalize judgment for their substance use and fear experiencing stigma from others. The scale includes four subscales: self-devaluation (8 items), fear of enacted stigma (9 items), stigma avoidance (13 items), and values disengagement (10 items). Total scale score ranges from 40-200, where higher scores reflect higher levels of self-stigma. The self-devaluation, fear of enacted stigma, and stigma avoidance subscales are scored normally, while the values disengagement subscale is reverse scored.

Time frame: Baseline, 4-week follow-up visit

Population: Includes participants not lost-to-follow-up with complete data.

ArmMeasureValue (MEAN)
Intervention ArmChange in Substance Abuse Self-Stigma Scale (SASSS) Score-14.47 score on a scale
Primary

Percentage of Participants Retained in Study (Feasibility - Retention)

Percentage of participants enrolled in the study who are retained through study completion (i.e., complete 4-week follow-up survey).

Time frame: From first enrollment visit to study completion date (up to 8 weeks)

ArmMeasureGroupValue (NUMBER)
Intervention ArmPercentage of Participants Retained in Study (Feasibility - Retention)Retained90 Percentage of participants
Intervention ArmPercentage of Participants Retained in Study (Feasibility - Retention)Not retained10 Percentage of participants
Primary

Percentage of Participants Who Read Messages Daily (Feasibility - User)

Percentage of participants who respond As soon as I saw them or Later that day to the 5-point Likert-type survey question On average, when would you read the text message you received?

Time frame: 4-week follow-up visit

ArmMeasureGroupValue (NUMBER)
Intervention ArmPercentage of Participants Who Read Messages Daily (Feasibility - User)Later that week, more than one week later, or Never0 Percentage of participants
Intervention ArmPercentage of Participants Who Read Messages Daily (Feasibility - User)As soon as I saw them or Later that day100 Percentage of participants
Primary

Percentage of Participants With Cell Phone Device Challenges (Feasibility - User)

Percentage of participants who respond yes to the binary survey question Between the start of the program and now, did you experience any challenges or changes with your phone (e.g., lost, broken) that prevented you from receiving or reading text messages?

Time frame: 4-week follow-up visit

ArmMeasureGroupValue (NUMBER)
Intervention ArmPercentage of Participants With Cell Phone Device Challenges (Feasibility - User)Yes37.0 Percentage of participants
Intervention ArmPercentage of Participants With Cell Phone Device Challenges (Feasibility - User)No59.3 Percentage of participants
Intervention ArmPercentage of Participants With Cell Phone Device Challenges (Feasibility - User)Unsure3.7 Percentage of participants
Primary

Percentage of Participants With Cell Phone Plan Challenges (Feasibility - User)

Percentage of participants who respond yes to the binary survey question Between the start of the program and now, did you experience any challenges or changes with your phone number or phone plan (e.g., changed number, ran out of minutes) that prevented you from receiving or reading text messages?

Time frame: 4-week follow-up visit

ArmMeasureGroupValue (NUMBER)
Intervention ArmPercentage of Participants With Cell Phone Plan Challenges (Feasibility - User)Yes22.2 Percentage of participants
Intervention ArmPercentage of Participants With Cell Phone Plan Challenges (Feasibility - User)No70.4 Percentage of participants
Intervention ArmPercentage of Participants With Cell Phone Plan Challenges (Feasibility - User)Unsure7.4 Percentage of participants
Primary

Percentage of Participants With High Text Message Frequency (Feasibility - User)

Percentage of participants who report every day to the 5-point Likert-type survey question Before the start of this program, how often did you send or receive text messages?

Time frame: 4-week follow-up visit

ArmMeasureGroupValue (NUMBER)
Intervention ArmPercentage of Participants With High Text Message Frequency (Feasibility - User)Every day74.1 Percentage of participants
Intervention ArmPercentage of Participants With High Text Message Frequency (Feasibility - User)A few times a week18.5 Percentage of participants
Intervention ArmPercentage of Participants With High Text Message Frequency (Feasibility - User)A few times a month7.4 Percentage of participants
Intervention ArmPercentage of Participants With High Text Message Frequency (Feasibility - User)Less than once a month0 Percentage of participants
Intervention ArmPercentage of Participants With High Text Message Frequency (Feasibility - User)Never0 Percentage of participants
Primary

Percentage of Participants With High Text Messaging Comfort (Feasibility - User)

Percentage of participants who report very comfortable or comfortable to the 5-point Likert-type survey question Before the start of this program, how comfortable were you with sending or receiving text messages?

Time frame: 4-week follow-up visit

ArmMeasureGroupValue (NUMBER)
Intervention ArmPercentage of Participants With High Text Messaging Comfort (Feasibility - User)Extremely comfortable63.0 Percentage of participants
Intervention ArmPercentage of Participants With High Text Messaging Comfort (Feasibility - User)Somewhat comfortable11.1 Percentage of participants
Intervention ArmPercentage of Participants With High Text Messaging Comfort (Feasibility - User)Neither comfortable nor uncomfortable11.1 Percentage of participants
Intervention ArmPercentage of Participants With High Text Messaging Comfort (Feasibility - User)Somewhat uncomfortable11.1 Percentage of participants
Intervention ArmPercentage of Participants With High Text Messaging Comfort (Feasibility - User)Extremely uncomfortable3.7 Percentage of participants
Primary

Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment)

Percentage of potential participants screened for study eligibility who are eligible for participation.

Time frame: From first recruitment visit to last recruitment visit (up to 4 weeks)

Population: Includes all screened prospective participants

ArmMeasureGroupValue (NUMBER)
Intervention ArmPercentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment)Eligible93.8 Percentage of participants
Intervention ArmPercentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment)Ineligible6.3 Percentage of participants
Primary

Percentage of Prospective Participants Recruited Into Study (Feasibility - Enrollment)

Percentage of potential participants screened for study eligibility who enroll in the study.

Time frame: From first recruitment visit to last enrollment visit (up to 4 weeks)

Population: Includes eligible prospective participants

ArmMeasureGroupValue (NUMBER)
Intervention ArmPercentage of Prospective Participants Recruited Into Study (Feasibility - Enrollment)Enrolled66.7 Percentage of participants
Intervention ArmPercentage of Prospective Participants Recruited Into Study (Feasibility - Enrollment)Not enrolled33.3 Percentage of participants
Primary

Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User)

This is a 16-item Likert-type questionnaire designed to assess acceptability of the intervention from the participants' perspective along the eight dimensions of the Theoretical Framework of Acceptability: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self-efficacy, and general acceptability. Total score ranges from 16-64, with higher scores indicating greater acceptability of the intervention.

Time frame: 4-week follow-up visit

ArmMeasureValue (MEAN)Dispersion
Intervention ArmTheoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User)56.74 score on a scaleStandard Deviation 5.49
Primary

Time to Sample Saturation (Feasibility - Recruitment)

Time in days to enroll the full sample size (n=30), starting from the first recruitment visit

Time frame: From first recruitment visit to last enrollment visit (up to 4 weeks)

ArmMeasureValue (NUMBER)
Intervention ArmTime to Sample Saturation (Feasibility - Recruitment)14 days
Secondary

Change in Adult Dispositional Hope Scale Score

This is a 12-item Likert-type scale that assesses participants' hope (i.e., positive attitude toward the future). Total scale score ranges from 12-96, where higher scores indicate greater hope.

Time frame: Baseline, 4-week follow-up visit

Population: Includes participants not lost-to-follow-up with complete data.

ArmMeasureValue (MEAN)
Intervention ArmChange in Adult Dispositional Hope Scale Score1.58 score on a scale
Secondary

Change in Rosenberg Self-Esteem Scale Score

This is a 10-item Likert-type scale that assesses participants' self-esteem. Total scale score range from 10-40, where higher scores indicate greater self-esteem.

Time frame: Baseline, 4-week follow-up visit

Population: Includes participants not lost-to-follow-up with complete data.

ArmMeasureValue (MEAN)
Intervention ArmChange in Rosenberg Self-Esteem Scale Score3.13 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026