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Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment

Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement,

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06266572
Acronym
OASIS
Enrollment
19
Registered
2024-02-20
Start date
2021-09-30
Completion date
2023-09-29
Last updated
2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder

Brief summary

C4 Innovations (C4) and partners at Yale University (Yale) and the West Haven VA Medical Center (WHVA) proposed to develop and test OASIS (Overcoming and Addressing Stigma in Substance Use Disorders), a web-based educational platform for primary care clinicians and individuals with Opioid Use Disorder. The major aims of the study were to: 1. Develop a prototype of OASIS for patients with Opioid Use Disorder (OUD) and primary care clinicians; conduct usability testing. 2. Pilot OASIS with a small sample of individuals with untreated OUD and their clinicians to determine feasibility, acceptability, and preliminary product effectiveness for a Phase II effectiveness trial. After development of the prototype, the C4-Yale-WHVA team planned to test OASIS with patients (N = 30) and clinicians (N = 5) using validated measures and qualitative interviews to assess usability, satisfaction, knowledge, empowerment, and stigma.

Interventions

BEHAVIORALOvercoming and Addressing Stigma in Substance Use Disorders (OASIS)

Web-based educational platform for clinicians and individuals with OUD that will decrease barriers to care and enhance treatment outcomes

Sponsors

Center for Social Innovation, Massachusetts
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

For providers: * Clinically active and seeing patients; * Having a device with Internet access to use the OASIS prototype * English speaking * Willing and able to complete data collection activities. For patients: * Diagnosed OUD * Unmet substance use treatment need * Has an upcoming primary care visit scheduled for the intervention period (1-2 months) * English speaking * Has access to a device with Internet access to use the OASIS prototype * Willing and able to complete data collection activities

Exclusion criteria

Patient participants will be excluded from this study if they: 1\) Currently receiving or have received medication for opioid dependence.

Design outcomes

Primary

MeasureTime frameDescription
Open Minds Scale for Health Care ProvidersAssessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.Description: A 20-item scale assessing stigma in health care providers, rated on a 5 point likert scale from Strongly Disagree (1) to Strongly Agree (5).
Brief Opioid Stigma ScaleAssessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.An 8-item scale assessing perceptions of stigma and endorsed stigma toward individuals using opioids. Rated on a 5 point likert scale from Strongly Disagree (1) to Strongly Agree (5). Providers in this study did not complete the items on the Harm subscale, items 9-12.
Perceived Stigma of Addiction ScaleAssessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.An 8-item scale assessing perceptions of stigma towards individuals with substance use disorders. Rated on a 7 point likert scale from Very Strongly Disagree (1) to Very Strongly Agree (7).
Knowledge CheckAssessed at both timepoints: prior to accessing the online platform and after using the platform for at least one weekA 10-item assessment developed by the research team to assess knowledge of opioids and opioid use disorder
System Usability ScaleAssess only at the post-assessment, after using the platform for at least one week.A 10-item measure assessing the overall usability of the online platform. Rated on a 5 point likert scale from Strongly Disagree (1) to Strongly Agree (5).
Internalized Stigma of Mental Illness ScaleAssessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.A 29-item measure assessing the participant's own stigma relating to mental illness. Rated on a 4 point likert scale from Strongly Disagree (1) to Strongly Agree (4).
Recovery Empowerment ScaleAssessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.A 20-item scale assessing a participant's levels of empowerment, rated on a 7 point likert scale from Almost Never (1) to Almost Always (7).
Mental Health Seeking Attitudes ScaleAssessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.A 9-item scale assessing the individuals rating between two dichotomous choices and how accurately they describe their perceptions of help-seeking. Participants are asked to choose one of two words on a scale (e.g., useless vs. useful) and are asked to rate how strongly they feel this word describes their thoughts on a scale from Undecided (0) to Extremely (3).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026