N/A
N=30
Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs
Stigma, Social · Substance Use
Bottom Line
View on ClinicalTrials.gov: NCT06281548 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in Stigma Resistance Scale (SRS) Score — 6.28 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RESTART (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Stigma Resistance Scale (SRS) Score |
6.28 | — |
| PRIMARY Change in Substance Abuse Self-Stigma Scale (SASSS) Score |
-14.47 | — |
| PRIMARY Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment) |
93.8; 6.3 | — |
| PRIMARY Percentage of Prospective Participants Recruited Into Study (Feasibility - Enrollment) |
66.7; 33.3 | — |
| PRIMARY Time to Sample Saturation (Feasibility - Recruitment) |
14 | — |
| PRIMARY Percentage of Participants Retained in Study (Feasibility - Retention) |
90; 10 | — |
| PRIMARY Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User) |
56.74 | — |
| PRIMARY Percentage of Participants With High Text Message Frequency (Feasibility - User) |
74.1; 18.5; 7.4; 0; 0 | — |
| PRIMARY Percentage of Participants With High Text Messaging Comfort (Feasibility - User) |
63.0; 11.1; 11.1; 11.1; 3.7 | — |
| PRIMARY Percentage of Participants With Cell Phone Device Challenges (Feasibility - User) |
37.0; 59.3; 3.7 | — |
| PRIMARY Percentage of Participants With Cell Phone Plan Challenges (Feasibility - User) |
22.2; 70.4; 7.4 | — |
| PRIMARY Percentage of Participants Who Read Messages Daily (Feasibility - User) |
100; 0 | — |
| SECONDARY Change in Adult Dispositional Hope Scale Score |
1.58 | — |
| SECONDARY Change in Rosenberg Self-Esteem Scale Score |
3.13 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06281548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.