Alcohol Use Disorder (AUD)NCT04832321
Measuring Beliefs and Norms About Persons With Alcohol Use Disorder
A study testing Survey questionnaire in people with Alcohol Use Disorder (AUD), run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
Survey experiment to estimate drivers of stigma toward people with alcohol use disorder Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Survey questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,363 participants
- Where
- 1 siteUganda
- Study dates
- 19 Feb 2021to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adults who consider Nyakabare their primary place of residence and who are capable of providing consent
Who cannot join
- Minors younger than 18 years of age, with the exception of emancipated minors
- Persons who do not consider Nyakabare Parish their primary place of residence, e.g., persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside the parish
- Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
Trial locations and contacts
1 site in 1 country.
About this study
Survey experiment to estimate drivers of stigma toward people with alcohol use disorder
Read the detailed description
Despite significant advances in scientific understanding of substance use disorders accompanied by significant advances in treatment and improvements in prognosis, substance use disorder remains highly stigmatized throughout the world. Previous studies suggest that portraying alcohol use disorder as treatable can reduce negative attitudes toward persons with alcohol use disorder. This randomized controlled trial compares the effects of exposing study participants to vignettes portraying persons with untreated and symptomatic alcohol use disorder vs. treated alcohol use disorder with complete response vs. treated alcohol use disorder with relapse, with and without adverse economic impacts. It is hypothesized, based on prior work, that study participants exposed to vignettes depicting treated alcohol use disorder with completed response would have the greatest effect on reducing negative attitudes toward persons with alcohol use disorder, followed by treated alcohol use disorder with relapse and untreated and symptomatic alcohol use disorder, and that adverse economic impacts will exacerbate negative attitudes toward persons with alcohol use disorder.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Survey questionnaire
- Keywords
- Stigma
- Medical subject headings
- Alcoholism, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey questionnaireOther
Each version of the questionnaire portrays a young Ugandan man with different profiles of illness severity, treatment, and treatment response.
| Study group | Role | What they receive |
|---|---|---|
| No intervention: V1: Control | No intervention | This version of the survey questionnaire depicts a young man with no symptoms of alcohol use disorder |
| Experimental: V2: Alcohol Use Disorder | Experimental | As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder. Receives: Other: Survey questionnaire |
| Experimental: V3: Alcohol Use Disorder + Treatment with Response | Experimental | As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder who is successfully treated with complete response. Receives: Other: Survey questionnaire |
| Experimental: V4: Alcohol Use Disorder + Treatment with Relapse | Experimental | As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder who is successfully treated with partial relapse. Receives: Other: Survey questionnaire |
| Experimental: V5: Alcohol Use Disorder + Economic Impact | Experimental | As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder whose untreated alcohol use disorder negatively affects his family's finances. Receives: Other: Survey questionnaire |
| Experimental: V6: Alcohol Use Disorder + Economic Impact + Treatment with Response | Experimental | As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder whose untreated alcohol use disorder negatively affects his family's finances, who is then successfully treated with complete response. Receives: Other: Survey questionnaire |
| Experimental: V7: Alcohol Use Disorder + Economic Impact + Treatment with Relapse | Experimental | As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder whose untreated alcohol use disorder negatively affects his family's finances, who is then successfully treated with partial relapse and continued negative economic impact. Receives: Other: Survey questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Distance
Willingness to have the man portrayed in the vignette to marry into the study participant's family (single item, culturally adapted instrument developed specifically for this study; response options yes/no)
Measured: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
Perceived Norms about Social Distance
Study participant's perception of the extent to which other people would be willing to have the man portrayed in the vignette to marry into their families (single item, culturally adapted instrument developed specifically for this study; response options on a Likert-type scale: 1=all or almost all; 2=more than half but less than all; 3=fewer than half but more than no one; 4=very few or no one)
Measured: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
Negative Attitudes (Attribution)
Personal belief that the symptoms of the man portrayed in the vignette represent divine punishment (single item, culturally adapted instrument developed specifically for this study; response options yes/no)
Measured: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
Perceived Norms about Negative Attitudes (Attribution)
Study participant's perception of the extent to which other people believe that the symptoms of the man portrayed in the vignette represent divine punishment (single item, culturally adapted instrument developed specifically for this study; response options on a Likert-type scale: 1=all or almost all; 2=more than half but less than all; 3=fewer than half but more than no one; 4=very few or no one)
Measured: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
Negative Attitudes (Shame)
Personal belief that the symptoms of the man portrayed in the vignette bring shame upon his family (single item, culturally adapted instrument developed specifically for this study; response options yes/no)
Measured: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
Perceived Norms about Negative Attitudes (Shame)
Study participant's perception of the extent to which other people believe that the symptoms of the man portrayed in the vignette bring shame upon his family (single item, culturally adapted instrument developed specifically for this study; response options on a Likert-type scale: 1=all or almost all; 2=more than half but less than all; 3=fewer than half but more than no one; 4=very few or no one)
Measured: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start19 Feb 2021
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Responsible party
- Principal investigator, Alexander Tsai, Massachusetts General Hospital
- Investigators
- Alexander C Tsai, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832321
- Sponsor's protocol ID
- 2013P000395_1
- Status last verified
- Oct 2023
- First submitted
- 1 Apr 2021
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Beliefs and Norms About Persons With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04832321
- Acronym / sponsor ID
- 2013P000395_1
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Stigma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,363 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Survey experiment to estimate drivers of stigma toward people with alcohol use disorder
Detailed description
Despite significant advances in scientific understanding of substance use disorders accompanied by significant advances in treatment and improvements in prognosis, substance use disorder remains highly stigmatized throughout the world. Previous studies suggest that portraying alcohol use disorder as treatable can reduce negative attitudes toward persons with alcohol use disorder. This randomized controlled trial compares the effects of exposing study participants to vignettes portraying persons with untreated and symptomatic alcohol use disorder vs. treated alcohol use disorder with complete response vs. treated alcohol use disorder with relapse, with and without adverse economic impacts. It is hypothesized, based on prior work, that study participants exposed to vignettes depicting treated alcohol use disorder with completed response would have the greatest effect on reducing negative attitudes toward persons with alcohol use disorder, followed by treated alcohol use disorder with relapse and untreated and symptomatic alcohol use disorder, and that adverse economic impacts will exacerbate negative attitudes toward persons with alcohol use disorder.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| No intervention: V1: Control | No intervention | –This version of the survey questionnaire depicts a young man with no symptoms of alcohol use disorder |
| Experimental: V2: Alcohol Use Disorder | Experimental | Other: Survey questionnaireAs this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder. |
| Experimental: V3: Alcohol Use Disorder + Treatment with Response | Experimental | Other: Survey questionnaireAs this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder who is successfully treated with complete response. |
| Experimental: V4: Alcohol Use Disorder + Treatment with Relapse | Experimental | Other: Survey questionnaireAs this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder who is successfully treated with partial relapse. |
| Experimental: V5: Alcohol Use Disorder + Economic Impact | Experimental | Other: Survey questionnaireAs this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder whose untreated alcohol use disorder negatively affects his family's finances. |
| Experimental: V6: Alcohol Use Disorder + Economic Impact + Treatment with Response | Experimental | Other: Survey questionnaireAs this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder whose untreated alcohol use disorder negatively affects his family's finances, who is then successfully treated with complete response. |
| Experimental: V7: Alcohol Use Disorder + Economic Impact + Treatment with Relapse | Experimental | Other: Survey questionnaireAs this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder whose untreated alcohol use disorder negatively affects his family's finances, who is then successfully treated with partial relapse and continued negative economic impact. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults who consider Nyakabare their primary place of residence and who are capable of providing consent
Key exclusion criteria (3 listed)
- Minors younger than 18 years of age, with the exception of emancipated minors
- Persons who do not consider Nyakabare Parish their primary place of residence, e.g., persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside the parish
- Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey questionnaireEach version of the questionnaire portrays a young Ugandan man with different profiles of illness severity, treatment, and treatment response. | Other | Experimental: V2: Alcohol Use Disorder, Experimental: V3: Alcohol Use Disorder + Treatment with Response, Experimental: V4: Alcohol Use Disorder + Treatment with Relapse, Experimental: V5: Alcohol Use Disorder + Economic Impact, Experimental: V6: Alcohol Use Disorder + Economic Impact + Treatment with Response, Experimental: V7: Alcohol Use Disorder + Economic Impact + Treatment with Relapse |
Primary outcome
Social Distance
Time frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
Willingness to have the man portrayed in the vignette to marry into the study participant's family (single item, culturally adapted instrument developed specifically for this study; response options yes/no)
Perceived Norms about Social Distance
Time frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
Study participant's perception of the extent to which other people would be willing to have the man portrayed in the vignette to marry into their families (single item, culturally adapted instrument developed specifically for this study; response options on a Likert-type scale: 1=all or almost all; 2=more than half but less than all; 3=fewer than half but more than no one; 4=very few or no one)
Negative Attitudes (Attribution)
Time frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
Personal belief that the symptoms of the man portrayed in the vignette represent divine punishment (single item, culturally adapted instrument developed specifically for this study; response options yes/no)
Perceived Norms about Negative Attitudes (Attribution)
Time frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
Study participant's perception of the extent to which other people believe that the symptoms of the man portrayed in the vignette represent divine punishment (single item, culturally adapted instrument developed specifically for this study; response options on a Likert-type scale: 1=all or almost all; 2=more than half but less than all; 3=fewer than half but more than no one; 4=very few or no one)
Negative Attitudes (Shame)
Time frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
Personal belief that the symptoms of the man portrayed in the vignette bring shame upon his family (single item, culturally adapted instrument developed specifically for this study; response options yes/no)
Perceived Norms about Negative Attitudes (Shame)
Time frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)
Study participant's perception of the extent to which other people believe that the symptoms of the man portrayed in the vignette bring shame upon his family (single item, culturally adapted instrument developed specifically for this study; response options on a Likert-type scale: 1=all or almost all; 2=more than half but less than all; 3=fewer than half but more than no one; 4=very few or no one)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder (AUD)
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Not yet recruiting
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making.
Alcohol Use Disorder (AUD), Suicidal Ideation
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Not yet recruiting
eTSF for Latinx Young Adults With Alcohol Use Disorder
Alcohol Use Disorder (AUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander C Tsai, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey questionnaire in people with Alcohol Use Disorder (AUD), run by Massachusetts General Hospital at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Distance (time frame: Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.