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

NCT06281548 | Completed Results

• 2 other identifiers: 23-29371F31DA058452
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stigma, Social; Substance Use

Keywords

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

Outcome Measures

Primary Outcomes (12)

• 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.

  Baseline, 4-week follow-up visit

• 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.

  Baseline, 4-week follow-up visit

• 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)

• 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)

• 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)

• 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)

• 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.

  4-week follow-up visit

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Change in Adult Dispositional Hope Scale Score

  Baseline, 4-week follow-up visit

• Change in Rosenberg Self-Esteem Scale Score

  Baseline, 4-week follow-up visit

Study Arms (1)

Intervention arm

EXPERIMENTAL

Participants in the intervention arm will receive 56 text messages over 4-weeks.

Behavioral: RESTART

Interventions

RESTART BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

SHRPS Syringe Service Program

Portsmouth, Ohio, 45662, United States

Location

Related Publications (2)

• Sibley AL, Muessig KE, Noar SM, Gottfredson O'Shea N, Miller WC, Go VF. Promoting substance use stigma resistance through an automated text message intervention (project RESTART): Outcomes of a pilot feasibility trial. J Subst Use Addict Treat. 2025 May;172:209671. doi: 10.1016/j.josat.2025.209671. Epub 2025 Mar 6.

  PMID: 40057241 DERIVED

• Sibley AL, Noar SM, Muessig KE, O'Shea NG, Paquette CE, Spears AG, Miller WC, Go VF. An Automated Text Messaging Intervention to Reduce Substance Use Self-Stigma (Project RESTART): Protocol for a Feasibility and Acceptability Pilot Study. JMIR Res Protoc. 2024 Aug 9;13:e59224. doi: 10.2196/59224.

  PMID: 39121478 DERIVED

MeSH Terms

Conditions

Social Stigma; Substance-Related Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders; Personal Satisfaction

Results Point of Contact

• Title: Adams Sibley
• Organization: University of North Carolina-Chapel Hill

asibley@live.unc.edu

423-227-9198

Study Officials

• Adams L Sibley, MPH

  Doctoral Candidate

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 28, 2024
• Study Start: February 29, 2024
• Primary Completion: April 14, 2024
• Study Completion: April 14, 2024
• Last Updated: July 10, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. Requests should be submitted via email to the Principal Investigator at asibley@live.unc.edu.

Locations

US (1)