Stigma Reduction for Substance Use Disorder

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

Disqualifiers: Tobacco use disorder, Legal issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to reduce stigma in mental health services for people who use drugs. It tests whether combining professional training with a policy change (a multi-level stigma reduction intervention) improves care more than training alone (a single-level stigma reduction intervention). The researchers aim to demonstrate that this approach can enhance experiences and outcomes for patients with substance use issues. The trial focuses on mental health professionals at certain sites, and new patients with substance use concerns may notice changes in their care. As an unphased trial, this study provides patients the opportunity to contribute to innovative approaches that could enhance care and reduce stigma in mental health services.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this stigma reduction intervention is safe for mental health services?

Research has shown that programs aimed at reducing stigma around substance use are generally well-received. These programs, which may include educational sessions or a combination of training and policy changes, typically do not cause negative side effects.

One study examined several stigma-reducing programs and found them to be creative and possibly cost-effective, with no major negative effects reported. Both simple and complex approaches to reducing stigma are safe for participants. These programs focus on changing thoughts and behaviors, so they do not involve medications or physical treatments that could be harmful.

Furthermore, the testing of these programs in trials without specific safety concerns further supports their safety. Overall, participating in such a trial is unlikely to pose any health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to reduce stigma associated with substance use disorder through innovative approaches. Unlike typical treatments that focus solely on medical or psychological interventions, this trial explores stigma reduction by educating mental health professionals and changing policy. The experimental approach combines educational training with a novel controlled substance agreement that emphasizes shared decision-making, a method that could make interactions between patients and healthcare providers more collaborative and respectful. By addressing stigma directly, this trial hopes to improve patient care and outcomes in a way that current standard treatments do not.

What evidence suggests that this trial's interventions could be effective for reducing stigma in substance use disorder?

Research shows that different methods to reduce stigma can improve care for people with substance use disorders. A review of these methods found they often lead to better treatment results by lowering stigma. In this trial, one arm combines policy changes with professional education to help reduce stigma among mental health providers. This approach aims to create a more supportive environment for patients. By including shared decision-making in policies, providers can improve communication and focus more on patient needs. Another arm focuses on educational training only. These early findings suggest that addressing stigma in various ways can lead to better health services for people who use drugs. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for mental health service providers. It aims to reduce stigma towards patients with substance use disorders. Providers who are willing to participate in educational training and potentially adopt a new policy agreement on controlled substances can join.

Inclusion Criteria

Existing and new patients with alcohol use disorder (AUD)/opioid use disorder (OUD) will be included in the EHR data sample

The other half of the survey sample (n=20) will include patients who do have an ICD-10 code for SUD in their chart

Psychiatrists or psychiatric NPs employed at the participating LSH site are eligible to participate

Exclusion Criteria

Patients with SUD diagnosis only for a tobacco use disorder will be excluded from the SUD-stratified portion of the survey sample

Patients unable or unwilling to give written informed consent will be excluded

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 be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of educational training and organizational policy change to reduce stigma in mental health services

3 months

Ongoing visits as part of mental health services

Follow-up

Participants are monitored for changes in stigma and service provision effectiveness

6 weeks

Surveys conducted within 14 days pre-training, post-training, and 6 weeks post-training

What Are the Treatments Tested in This Trial?

Interventions

• Multi-level stigma reduction intervention: educational training plus controlled substance agreement policy change
• Single-level stigma reduction intervention: educational training

Trial Overview The study tests if adding an organizational policy change to professional stigma-reduction training improves attitudes toward drug users and patient care more than just the training alone. Mental health sites will be randomly chosen to either implement both interventions or just the education.

How Is the Trial Designed?

Group I: Experimental arm: educational training plus a policy change for controlled substance agreements Experimental Treatment 1 Intervention

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

Group II: Control arm: educational training only Active Control 1 Intervention

This arm received only an educational training for mental health professionals about substance use-related stigma

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

LifeStance Health

Collaborator

Trials

1

Recruited

10+

Loyola University Chicago

Collaborator

Trials

23

Recruited

13,100+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06200012

Multi-Level Stigma Intervention for Mental Health Services This cluster randomized trial develops and pilot tests a multi-level substance use stigma intervention that leverages organizational policy and professional ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37184615/

A multi-level intervention to reduce the stigma of substance ... This paper presents the protocol for a non-randomized trial of a multi-level stigma intervention called Combatting Stigma to Aid Reentry and Recovery (CSTARR)

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10184076/

A multi-level intervention to reduce the stigma of substance ... Stigma must be addressed in the criminal legal system to facilitate the uptake of evidence-based addiction care. This study is the first to ...

4. jcoinctc.org jcoinctc.org/multi-level-intervention-to-reduce-stigma-of-sud-and-cl-involvement/

Multi-Level Intervention to Reduce Stigma of SUD and CL ... The study uses various scales to evaluate the staff's and clients' stigma and the effectiveness of the interventions that aim to improve treatment outcomes and ...

5. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-018-1244-y

A systematic review of multi-level stigma interventions We conducted the first systematic review of original research on multi-level stigma-reduction interventions.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0099176725000807

Interventions for Reducing Mental Health–Related Stigma ... This review highlights the critical need for targeted interventions to reduce mental health–related stigma among emergency health care professionals, including ...