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OpenTrials
Completed

NCT Number: NCT06266572

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

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West Haven VA Medical Center

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • Currently receiving or have received medication for opioid dependence.

Treatment and study plan

Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)

Behavioral

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

Primary outcomes

  1. Open Minds Scale for Health Care Providers

    Time frame: Assessed 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).

  2. Brief Opioid Stigma Scale

    Time frame: Assessed 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.

  3. Perceived Stigma of Addiction Scale

    Time frame: Assessed 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).

  4. Knowledge Check

    Time frame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week

    A 10-item assessment developed by the research team to assess knowledge of opioids and opioid use disorder

  5. System Usability Scale

    Time frame: Assess 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).

  6. Internalized Stigma of Mental Illness Scale

    Time frame: Assessed 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).

  7. Recovery Empowerment Scale

    Time frame: Assessed 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).

  8. Mental Health Seeking Attitudes Scale

    Time frame: Assessed 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).

Sponsors and collaborators

Lead sponsor

Center for Social Innovation, Massachusetts

Other

Registry information

Official study title

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

Acronym: OASIS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2024
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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