CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
RESTARTbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06281548
NCT06281548N/ACompleted

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

University of North Carolina, Chapel Hill·interventional·Posted Feb 28, 2024·Updated Jul 10, 2024

In Brief

A clinical study evaluating RESTART for Stigma, Social and Substance Use. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20252026
First PostedFeb 28, 2024
Enrollment StartFeb 29, 2024
Primary CompletionApr 14, 2024
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 2.3 years ago

Interventions

RESTARTbehavioral

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.