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

NCT ID: NCT06281548

Last Updated: 2024-07-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-04-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stigma, Social Substance Use

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention arm

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

Group Type EXPERIMENTAL

RESTART

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adams L Sibley, MPH

Role: PRINCIPAL_INVESTIGATOR

Doctoral Candidate

Locations

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SHRPS Syringe Service Program

Portsmouth, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40057241 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39121478 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1F31DA058452

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-2937

Identifier Type: -

Identifier Source: org_study_id

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