Viewing Study NCT06281548



Ignite Creation Date: 2024-05-06 @ 8:11 PM
Last Modification Date: 2024-10-26 @ 3:22 PM
Study NCT ID: NCT06281548
Status: COMPLETED
Last Update Posted: 2024-07-10
First Post: 2024-02-12

Brief Title: Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs
Sponsor: University of North Carolina Chapel Hill
Organization: University of North Carolina Chapel Hill

Study Overview

Official Title: Determining the Feasibility and Acceptability of a Novel Stigma Resistance Text Message Intervention for People Who Use Drugs
Status: COMPLETED
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 stigmacatching and challenging stigmatizing thoughts empowering oneself through learning about substance use and ones own recovery maintaining ones recovery and proving stigma wrong and developing a meaningful identity and purpose apart from ones 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 850000 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 eg HIV mental illness SUD stigma prevents uptake of treatment and harm reduction among people who use drugs PWUD contributing to needless morbidity eg infectious disease and mortality eg overdose and explains in part why only 65 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 HIVAIDS and mental illness self-stigma intervention literature Stigma resistance thus serves as an ideal conceptual framework and menu of strategies for the present studys 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 stigmacatching and challenging stigmatizing thoughts empowering oneself through learning about substance use and ones own recovery maintaining ones recovery and proving stigma wrong and developing a meaningful identity and purpose apart from ones 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1F31DA058452 NIH None httpsreporternihgovquickSearch1F31DA058452