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| ID | Type | Description | Link |
|---|---|---|---|
| UG1DA049468 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of New Mexico | OTHER |
| Loyola University Chicago | OTHER |
| LifeStance Health | UNKNOWN |
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This cluster randomized trial develops and pilot tests a multi-level substance use stigma intervention that leverages organizational policy and professional education to address structural and professional drivers of stigma in outpatient mental health (MH) services. The investigators will generate preliminary data to determine whether adding an organizational policy to a professional stigma training may reduce measures of provider-based stigma towards substance use and improve care quality and patient outcomes to a greater degree than simply conducting training alone. The investigators hypothesize that providers at a MH site implementing an organizational policy change in addition to providing professional training will demonstrate greater improvement to health services for people who use drugs compared to a site where providers receive training alone.
Substance use is commonly stigmatized, even in health settings. Stigma toward people who use drugs (PWUD) arises from multiple sources, including policies and individuals who carry out policies ("structural stigma") and health professionals ("provider-based stigma"). This study seeks to answer the question of whether addressing organizational-level structural stigma toward PWUD enhances the behavioral effects of stigma training among professionals providing mental health (MH) services.
This study will have two intervention groups: A MH clinic where the providers receive only the educational intervention and a MH clinic where the providers receive both the educational intervention and an organizational policy change. The investigators hypothesize that providers at a MH site implementing an organizational policy change in addition to providing professional training will demonstrate greater improvement to health services for PWUD compared to a site where providers receive training alone.
Only a small body of research develops and evaluates interventions seeking to reduce structural and provider-based stigma toward PWUD in healthcare settings or investigates the impact of such interventions on provision of evidence-based interventions like substance use disorder (SUD) pharmacotherapy. Little is known about substance use stigma in MH settings in particular, although some research suggests psychiatrist stigma toward dual diagnosis patients is greater than toward patients with either a SUD or MH diagnosis alone. Extant studies on stigma toward PWUD in healthcare found educational interventions incorporating critical reflection techniques and contact with PWUD significantly reduced provider-based stigma. But most provider-based stigma intervention studies have two major weaknesses: 1) failing to address structural drivers of stigma, such as organizational policies motivating attitudes and behaviors, and 2) falling short of practical application because they largely focus on professional attitudes without measuring changes to service provision. The investigators propose to pilot test a multi-level stigma intervention that leverages what existing research suggests works in professional stigma education, and adds a novel component of organizational policy change within a MH clinic. Because so little research exists on organizational-level stigma interventions, the investigators will use an inductive approach to identify a promising feasible policy that may reduce stigma toward PWUD. Our pilot testing will assess the extent to which combining interventions that modify structural/organizational and individual/professional-level drivers of stigma in outpatient MH services may improve not only attitudes but also health service provision to PWUD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm: educational training only | Active Comparator | This arm received only an educational training for mental health professionals about substance use-related stigma |
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| Experimental arm: educational training plus a policy change for controlled substance agreements | Experimental | This arm received both 1) an educational training for mental health professionals about substance use-related stigma; and 2) a policy change that replaced the standard LifeStance Health system's "controlled substance agreement" (CSA) with a new agreement integrating principles of shared decision-making and offering prescribers a communication tool with suggestions for how to implement principles of shared decision-making and patient centered care in their use of the new CSA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-level stigma reduction intervention: educational training plus controlled substance agreement policy change | Behavioral | Pairing a professional training targeting known attitudinal and knowledge drivers of substance use stigma with a policy altering potentially stigmatizing features of controlled substance agreements. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients where substance use was addressed during a MH visit among new intakes and documented in EHR | Identified ICD-10s or notes among participating providers in electronic health records (EHR) | 3-months prior to intervention vs. 3-months after intervention |
| Number of patients in the provider panel (new or old) diagnosed with OUD or AUD who initiated OUD or AUD pharmacotherapy | Whether pharmacotherapy for opioid use disorders (OUD) or alcohol use disorders (AUD) was initiated for patients with ICD-10s for OUD or AUD, as indicated in electronic health records (EHR) | 3-months prior to intervention vs. 3-months after intervention |
| Three-month retention in MH services for new patients whose EHR indicate substance use or SUD | Measured as any return visit for mental health (MH) services, as documented in electronic health records (EHR) for patients with ICD-10s for substance use disorders (SUD) or any indication of substance use in provider notes | 3-months prior to intervention vs. 3-months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Training intervention feasibility | Assessed among professionals in training using Feasibility of Intervention Measure (FIM) in post-training surveys | up to 14 days after training |
| Training intervention acceptability |
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Inclusion Criteria:
Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study.
Site inclusion:
Provider inclusion:
Patient EHR inclusion:
Patient survey inclusion:
Exclusion Criteria:
All individuals meeting any of the exclusion criteria will be excluded from study participation.
Provider exclusion:
Patient exclusion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LifeStance Health | Albuquerque | New Mexico | 87106 | United States |
Primary data for this study will be available to the public in the NIDA data repository, per NIDA CTN policy.
After publication of primary outcomes analysis
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 3, 2026 | |
| Reset | Jun 29, 2026 |
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Providers in the experimental and control arms are are not masked. Providers in the experimental arm have a policy at their clinic change, and they are aware of the policy change. The control arm does not implement the policy change, but may be aware of the policy change in the other arm. Both arms receive an educational intervention.
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| Single-level stigma reduction intervention: educational training | Behavioral | A professional training targeting known attitudinal and knowledge drivers of substance use stigma |
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Assessed among professionals in training using Acceptability of Intervention Measure (AIM) in post-training surveys
| up to 14 days after training |
| Training intervention appropriateness | Assessed among professionals in training using Intervention Appropriateness Measure (IAM) in post-training surveys | up to 14 days after training |
| Professional Stigma measured with Social Distance Scale (SDS) | Measures willingness to have several kinds of social relationships among professionals in training, and adapted for three populations: relationships with people who actively use drugs, with people who used to use drugs, and with people treated with opioid agonist treatment. Assessed in longitudinal surveys (within 14 days pre-training, within 14 days post-training, and 6-weeks post-training). Lower score indicates greater stigma, min=12 and max=60. | up to 14 days before training, up to 14 days after training, and 6-weeks after training |
| Professional Stigma measured with Medical Condition Regard Scale (MCRS) | Measures endorsed provider-based stigma toward patients with a specific diagnosis among professionals in training. Assessed in longitudinal surveys (within 14 days pre-training, within 14 days post-training, and 6-weeks post-training). Lower score indicates greater stigma, min=7 and max=35. | up to 14 days before training, up to 14 days after training, and 6-weeks after training |
| Professional Stigma measured with Perceived Dangerousness Scale | Measures perceptions of the dangerousness of a stigmatized group among professionals in training. Assessed in longitudinal surveys (within 14 days pre-training, within 14 days post-training, and 6-weeks post-training). Lower score indicates greater stigma, min=5 and max=25. | up to 14 days before training, up to 14 days after training, and 6-weeks after training |
| Patient-reported stigma measured with Internalized Stigma of Mental Illness Inventory (ISMI) | This measure is for patients and includes questions about anticipated stigma and internalized/self-stigma. This will be asked of a stratified random sample of patients of participating providers (n=20 with a SUD and n=20 not diagnosed with an SUD). Lower score indicates less stigma, min=29 and max=116. | 6-week post-training survey |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 3, 2026 | Jun 29, 2026 |
| ID | Term |
|---|---|
| D057545 | Social Stigma |
| D019966 | Substance-Related Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
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