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

Substance Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281548
• Other study ID #: 23-2937
• Secondary ID: 1F31DA058452
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Adams L Sibley, MPH
• Phone: 423-227-9198
• Email: asibley[@]live.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stigma, Social
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	SHRPS Syringe Service Program	Portsmouth	Ohio

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 0-80.	Baseline, 4-week follow-up visit
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 0-160, 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.	Baseline, 4-week follow-up visit
Primary	Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment)	Percentage of potential participants screened for study eligibility who are eligible for participation.	From first recruitment visit to last recruitment visit (up to 4 weeks)
Primary	Percentage of Prospective Participants Recruited into Study (Feasibility - Enrollment)	Percentage of potential participants screened for study eligibility who enroll in the study.	From first recruitment visit to last enrollment visit (up to 4 weeks)
Primary	Time to Sample Saturation (Feasibility - Recruitment)	Time in days to enroll the full sample size (n=30), starting from the first recruitment visit	From first recruitment visit to last enrollment visit (up to 4 weeks)
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).	From first enrollment visit to study completion date (up to 8 weeks)
Primary	Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User)	This is an 18-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 0-56, with higher scores indicating greater acceptability of the intervention.	4-week follow-up visit
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?"	4-week follow-up visit
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?"	4-week follow-up visit
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?"	4-week follow-up visit
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?"	4-week follow-up visit
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?"	4-week follow-up visit
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 0-84, where higher scores indicate greater hope.	Baseline, 4-week follow-up visit
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.	Baseline, 4-week follow-up visit