Clinical trial NCT06281548: Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs
Official title: Determining the Feasibility and Acceptability of a Novel Stigma Resistance Text Message Intervention for People Who Use Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stigma, Social
Substance Use
Keywords: people who use drugs
rural health
stigma
behavioral interventions
mobile health
mental health
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

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

Primary outcomes:
measure: Change in Stigma Resistance Scale (SRS) Score
timeFrame: Baseline, 4-week follow-up visit
measure: Change in Substance Abuse Self-Stigma Scale (SASSS) Score
timeFrame: Baseline, 4-week follow-up visit
measure: Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment)
timeFrame: From first recruitment visit to last recruitment visit (up to 4 weeks)
measure: Percentage of Prospective Participants Recruited Into Study (Feasibility - Enrollment)
timeFrame: From first recruitment visit to last enrollment visit (up to 4 weeks)
measure: Time to Sample Saturation (Feasibility - Recruitment)
timeFrame: From first recruitment visit to last enrollment visit (up to 4 weeks)
measure: Percentage of Participants Retained in Study (Feasibility - Retention)
timeFrame: From first enrollment visit to study completion date (up to 8 weeks)
measure: Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User)
timeFrame: 4-week follow-up visit
measure: Percentage of Participants With High Text Message Frequency (Feasibility - User)
timeFrame: 4-week follow-up visit
measure: Percentage of Participants With High Text Messaging Comfort (Feasibility - User)
timeFrame: 4-week follow-up visit
measure: Percentage of Participants With Cell Phone Device Challenges (Feasibility - User)
timeFrame: 4-week follow-up visit
measure: Percentage of Participants With Cell Phone Plan Challenges (Feasibility - User)
timeFrame: 4-week follow-up visit
measure: Percentage of Participants Who Read Messages Daily (Feasibility - User)
timeFrame: 4-week follow-up visit
Secondary outcomes:
measure: Change in Adult Dispositional Hope Scale Score
timeFrame: Baseline, 4-week follow-up visit
measure: Change in Rosenberg Self-Esteem Scale Score
timeFrame: Baseline, 4-week follow-up visit
Other outcomes:
Locations:
city: Portsmouth
country: United States
facility: SHRPS Syringe Service Program
state: Ohio
Study officials:
affiliation: Doctoral Candidate
name: Adams L Sibley, MPH
role: PRINCIPAL_INVESTIGATOR
References: