Multi-Level Stigma Intervention for Mental Health Services

NCT06200012 | Completed

• 2 other identifiers: UG1DA049468 CTN-00137UG1DA049468
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Stigma; Substance Use Disorders; Mental Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• Training intervention feasibility

  up to 14 days after training

• Training intervention acceptability

  up to 14 days after training

• Training intervention appropriateness

  up to 14 days after training

• Professional Stigma measured with Social Distance Scale (SDS)

  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)

  up to 14 days before training, up to 14 days after training, and 6-weeks after training

Study Arms (2)

Control arm: educational training only

ACTIVE COMPARATOR

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

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

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

Interventions

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.

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

Single-level stigma reduction intervention: educational training BEHAVIORAL

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

Control arm: educational training only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The sites will be selected using convenience sampling.
• 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.
• 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.
• 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).

You may not qualify if:

• Providers may be excluded if they were not employed by LSH and seeing patients for the past three months at the time of enrollment.
• 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.

Sponsors & Collaborators

• Wayne State University: lead
• University of New Mexico: collaborator
• Loyola University Chicago: collaborator
• LifeStance Health: collaborator

Study Sites (1)

LifeStance Health

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Social Stigma; Substance-Related Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 10, 2024
• Study Start: November 6, 2023
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of primary outcomes analysis

Locations

US (1)