Social StigmaNCT06200012
Multi-Level Stigma Intervention for Mental Health Services
A study testing Single-level stigma reduction intervention: educational training in people with Social Stigma and Substance Use Disorders, run by Wayne State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Stigma, Substance Use Disorders, Mental Disorder
- What is being tested?
- Single-level stigma reduction intervention: educational training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2023to 8 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study.
- Site inclusion:
- The sites will be selected using convenience sampling.
- The inclusion criterion will be sites with at least 4 providers.
- Provider inclusion:
- Providers at participating sites will also be recruited using convenience sampling.
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- Any psychiatrists or psychiatric NPs are eligible to participate as long as they are employed at the participating LSH site.
- Patient EHR inclusion:
- All new patients entering mental health services during the 3-months prior and 3- months after the intervention will be included in the EHR data sample to assess whether substance use was addressed during their first visit and subsequent 3-month retention in care.
- Existing and new patients with alcohol use disorder (AUD)/opioid use disorder (OUD) will be identified through the EHR to assess pharmacotherapy initiation.
- Patient survey inclusion:
- Half of the survey sample (n=20) will include patients without a substance use disorder (SUD) documented in their chart at the time of data collection
- The other half of the survey sample (n=20) will include patients who do have an ICD-10 code for SUD in their chart.
- Patient stratification rationale: the intention is to compare experiences and perceptions of stigma among patients who have SUD noted in their EHR and those who do not. This is also to assess stigma among patients who may not have their substance use addressed during a MH visit but who have substance use related health risks and substance use disorders (assessed through the ASSIST questionnaire).
Who cannot join
- All individuals meeting any of the exclusion criteria will be excluded from study participation.
- Provider exclusion:
- Providers may be excluded if they were not employed by LSH and seeing patients for the past three months at the time of enrollment.
- Patient exclusion:
- Patients may be excluded from the SUD-stratified portion of the survey sample if their SUD diagnosis is only for a tobacco use disorder.
- Patients may also be excluded if they are unable or unwilling to give written informed consent.
- Patients who are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Level Stigma Intervention to Improve Access to Substance Use Care With Prescribing Providers in Mental Health Settings
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.
Read the detailed description
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.
- Conditions
- Social Stigma, Substance Use Disorders, Mental Disorder
- Being tested
- Multi-level stigma reduction intervention: educational training plus controlled substance agreement policy change, Single-level stigma reduction intervention: educational training
- Medical subject headings
- Social Stigma, Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-level stigma reduction intervention: educational training plus controlled substance agreement policy changeBehavioural
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.
Single-level stigma reduction intervention: educational trainingBehavioural
A professional training targeting known attitudinal and knowledge drivers of substance use stigma
| Study group | Role | What they receive |
|---|---|---|
| Control arm: educational training only | Active comparator | This arm received only an educational training for mental health professionals about substance use-related stigma Receives: Behavioral: Single-level stigma reduction intervention: educational training |
| 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 Receives: Behavioral: Multi-level stigma reduction intervention: educational training plus controlled substance agreement policy change |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 3-months prior to intervention vs. 3-months after intervention
Secondary outcomes (7)
Training intervention feasibility
Assessed among professionals in training using Feasibility of Intervention Measure (FIM) in post-training surveys
Measured: up to 14 days after training
Training intervention acceptability
Assessed among professionals in training using Acceptability of Intervention Measure (AIM) in post-training surveys
Measured: up to 14 days after training
Training intervention appropriateness
Assessed among professionals in training using Intervention Appropriateness Measure (IAM) in post-training surveys
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-week post-training survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start6 Nov 2023
- Primary completion8 Feb 2024
- Study completion8 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social StigmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, Loyola University Chicago, LifeStance Health
- Responsible party
- Principal investigator, Erin F. Madden, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200012
- Sponsor's protocol ID
- UG1DA049468 CTN-00137
- Other IDs
- UG1DA049468
- Status last verified
- Oct 2025
- First submitted
- 30 Nov 2023
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary data for this study will be available to the public in the NIDA data repository, per NIDA CTN policy.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Level Stigma Intervention to Improve Access to Substance Use Care With Prescribing Providers in Mental Health Settings
- ClinicalTrials.gov ID
- NCT06200012
- Acronym / sponsor ID
- UG1DA049468 CTN-00137
- Conditions
- Social Stigma, Substance Use Disorders, Mental Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- University of New Mexico, Loyola University Chicago, LifeStance Health
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2025 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm: educational training only | Active comparator | Behavioral: Single-level stigma reduction intervention: educational trainingThis arm received only an educational training for mental health professionals about substance use-related stigma |
| Experimental arm: educational training plus a policy change for controlled substance agreements | Experimental | Behavioral: Multi-level stigma reduction intervention: educational training plus controlled substance agreement policy changeThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (7 listed)
- All individuals meeting any of the exclusion criteria will be excluded from study participation.
- Provider exclusion:
- Patient exclusion:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-level stigma reduction intervention: educational training plus controlled substance agreement policy changePairing a professional training targeting known attitudinal and knowledge drivers of substance use stigma with a policy altering potentially stigmatizing features of controlled substance agreements. | Behavioural | Experimental arm: educational training plus a policy change for controlled substance agreements |
| Single-level stigma reduction intervention: educational trainingA professional training targeting known attitudinal and knowledge drivers of substance use stigma | Behavioural | Control arm: educational training only |
Primary outcome
Number of patients where substance use was addressed during a MH visit among new intakes and documented in EHR
Time frame: 3-months prior to intervention vs. 3-months after intervention
Identified ICD-10s or notes among participating providers in electronic health records (EHR)
Number of patients in the provider panel (new or old) diagnosed with OUD or AUD who initiated OUD or AUD pharmacotherapy
Time frame: 3-months prior to intervention vs. 3-months after intervention
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)
Three-month retention in MH services for new patients whose EHR indicate substance use or SUD
Time frame: 3-months prior to intervention vs. 3-months after intervention
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
7 secondary outcomes
Training intervention feasibility
Time frame: up to 14 days after training
Training intervention acceptability
Time frame: up to 14 days after training
Training intervention appropriateness
Time frame: up to 14 days after training
Professional Stigma measured with Social Distance Scale (SDS)
Time frame: 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)
Time frame: up to 14 days before training, up to 14 days after training, and 6-weeks after training
Professional Stigma measured with Perceived Dangerousness Scale
Time frame: 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)
Time frame: 6-week post-training survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: Yes. Primary data for this study will be available to the public in the NIDA data repository, per NIDA CTN policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-level stigma reduction intervention: educational training in people with Social Stigma and Substance Use Disorders, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients where substance use was addressed during a MH visit among new intakes and documented in EHR (time frame: 3-months prior to intervention vs. 3-months after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.