Multi-Level Stigma Intervention for Mental Health Services

NCT ID: NCT06200012

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2025-02-08

Brief 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. 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.

Conditions

Social Stigma; Substance Use Disorders; Mental Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control arm: educational training only

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

Group Type: ACTIVE_COMPARATOR

Single-level stigma reduction intervention: educational training

Intervention Type: BEHAVIORAL

A professional training targeting known attitudinal and knowledge drivers of substance use stigma

Experimental arm: educational training plus a policy change for controlled substance agreements

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 Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: BEHAVIORAL

Single-level stigma reduction intervention: educational training

A professional training targeting known attitudinal and knowledge drivers of substance use stigma

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Site inclusion:

• The sites will be selected using convenience sampling.
• The inclusion criterion will be sites with at least 4 providers.

2. Provider inclusion:

• Providers at participating sites will also be recruited using convenience sampling.
• Any psychiatrists or psychiatric NPs are eligible to participate as long as they are employed at the participating LSH site.

3. 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.

4. 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).

Exclusion Criteria

1. 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.

2. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of New Mexico

OTHER

Sponsor Role: collaborator

Loyola University Chicago

OTHER

Sponsor Role: collaborator

LifeStance Health

UNKNOWN

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Erin F. Madden

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

LifeStance Health

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

UG1DA049468

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1DA049468 CTN-00137

Identifier Type: -

Identifier Source: org_study_id