Mental IllnessNCT06279962
Survey Experiment to Estimate Level of Mental Illness Stigma Based on Condition and Gender
A study testing Survey questionnaire in people with Mental Illness and Stigma, Social, run by Yale University at 1 site in Uganda.
Trial summary
This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Illness, Stigma, Social
- What is being tested?
- Survey questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 1 siteUganda
- Study dates
- 15 Jun 2023to 15 Sep 2023
- 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 Buyende District their primary residence and who are capable of providing consent
Who cannot join
- Minors younger than 18 years of age
- Persons who do not consider Buyende District their primary place of residence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Level of Mental Illness Stigma Based on Condition and Gender
This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness.
Read the detailed description
This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness. This study utilizes eight vignettes portraying different mental illnesses and genders to measure the levels of mental illness stigma in the general community in rural Uganda.
- Conditions
- Mental Illness, Stigma, Social
- Being tested
- Survey questionnaire
- Keywords
- stigma, mental illness, low-income country
- Medical subject headings
- Mental Disorders, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey questionnaireOther
The intervention is being assigned to one of the 8 different versions of the survey vignette.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: V1: Woman with Major Depressive Disorder | Experimental | Depicting a young woman with symptomatic major depressive disorder Receives: Other: Survey questionnaire |
| Experimental: V2: Man with Major Depressive Disorder | Experimental | Depicting a young man with symptomatic major depressive disorder Receives: Other: Survey questionnaire |
| Experimental: V3: Man with Generalized Anxiety Disorder | Experimental | Depicting a young man with symptomatic generalized anxiety disorder Receives: Other: Survey questionnaire |
| Experimental: V4: Woman with Generalized Anxiety Disorder | Experimental | Depicting a young woman with symptomatic generalized anxiety disorder Receives: Other: Survey questionnaire |
| Experimental: V5: Woman with Schizophrenia | Experimental | Depicting a young woman with symptomatic schizophrenia Receives: Other: Survey questionnaire |
| Experimental: V6: Man with Schizophrenia | Experimental | Depicting a young man with symptomatic schizophrenia Receives: Other: Survey questionnaire |
| Experimental: V7: Woman with Alcohol Use Disorder | Experimental | Depicting a young woman with symptomatic alcohol use disorder Receives: Other: Survey questionnaire |
| Experimental: V8: Man with Alcohol Use Disorder | Experimental | Depicting a young man with symptomatic alcohol use disorder Receives: Other: Survey questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of acceptance for the individual depicted in the vignette as measured by PERSONAL ACCEPTANCE SCALE
The PAS is a 9-item questionnaire targeted to public stigma, the "negative attitudes, beliefs, and behaviors held within a community" against individuals with mental illness. Each yes adds one point to the scale, and five questions from each scale were reverse-scored to match the direction of the scale. The total number of points was divided by the number of questions (nine) and multiplied by ten to generate numbers between zero and ten for comparison purposes to the Broad Acceptance Scale. Higher scores indicated more acceptance and less stigma towards mental illness, while lower scores indicated less acceptance and more stigma towards mental illness.
Measured: Study period. For each interview, approximately 60 minutes.
Level of acceptance for the individual depicted in the vignette as measured by BROAD ACCEPTANCE SCALE
The BAS is a 9-item questionnaire targeted to structural stigma, the "societal-level conditions, cultural norms, and institutional practices that constrain the opportunities, resources, and wellbeing" for individuals with mental illness. Each yes adds one point to the scale, and five questions from each scale were reverse-scored to match the direction of the scale. There were ten questions, therefore it generated a score between zero and ten. Higher scores indicated more acceptance and less stigma towards mental illness, while lower scores indicated less acceptance and more stigma towards mental illness.
Measured: Study period. For each interview, approximately 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 Jun 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Empower Through Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279962
- Sponsor's protocol ID
- 2000034605_a
- Status last verified
- Jun 2024
- First submitted
- 14 Feb 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Level of Mental Illness Stigma Based on Condition and Gender
- ClinicalTrials.gov ID
- NCT06279962
- Acronym / sponsor ID
- 2000034605_a
- Conditions
- Mental Illness, Stigma, Social
- Keywords
- stigma, mental illness, low-income country
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Empower Through Health
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 28 Feb 2024 (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.
This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness.
Detailed description
This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness. This study utilizes eight vignettes portraying different mental illnesses and genders to measure the levels of mental illness stigma in the general community in rural Uganda.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Experimental: V1: Woman with Major Depressive Disorder | Experimental | Other: Survey questionnaireDepicting a young woman with symptomatic major depressive disorder |
| Experimental: V2: Man with Major Depressive Disorder | Experimental | Other: Survey questionnaireDepicting a young man with symptomatic major depressive disorder |
| Experimental: V3: Man with Generalized Anxiety Disorder | Experimental | Other: Survey questionnaireDepicting a young man with symptomatic generalized anxiety disorder |
| Experimental: V4: Woman with Generalized Anxiety Disorder | Experimental | Other: Survey questionnaireDepicting a young woman with symptomatic generalized anxiety disorder |
| Experimental: V5: Woman with Schizophrenia | Experimental | Other: Survey questionnaireDepicting a young woman with symptomatic schizophrenia |
| Experimental: V6: Man with Schizophrenia | Experimental | Other: Survey questionnaireDepicting a young man with symptomatic schizophrenia |
| Experimental: V7: Woman with Alcohol Use Disorder | Experimental | Other: Survey questionnaireDepicting a young woman with symptomatic alcohol use disorder |
| Experimental: V8: Man with Alcohol Use Disorder | Experimental | Other: Survey questionnaireDepicting a young man with symptomatic alcohol use disorder |
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 Buyende District their primary residence and who are capable of providing consent
Key exclusion criteria (2 listed)
- Minors younger than 18 years of age
- Persons who do not consider Buyende District their primary place of residence
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 questionnaireThe intervention is being assigned to one of the 8 different versions of the survey vignette. | Other | Experimental: V1: Woman with Major Depressive Disorder, Experimental: V2: Man with Major Depressive Disorder, Experimental: V3: Man with Generalized Anxiety Disorder, Experimental: V4: Woman with Generalized Anxiety Disorder, Experimental: V5: Woman with Schizophrenia, Experimental: V6: Man with Schizophrenia, Experimental: V7: Woman with Alcohol Use Disorder, Experimental: V8: Man with Alcohol Use Disorder |
Primary outcome
Level of acceptance for the individual depicted in the vignette as measured by PERSONAL ACCEPTANCE SCALE
Time frame: Study period. For each interview, approximately 60 minutes.
The PAS is a 9-item questionnaire targeted to public stigma, the "negative attitudes, beliefs, and behaviors held within a community" against individuals with mental illness. Each yes adds one point to the scale, and five questions from each scale were reverse-scored to match the direction of the scale. The total number of points was divided by the number of questions (nine) and multiplied by ten to generate numbers between zero and ten for comparison purposes to the Broad Acceptance Scale. Higher scores indicated more acceptance and less stigma towards mental illness, while lower scores indicated less acceptance and more stigma towards mental illness.
Level of acceptance for the individual depicted in the vignette as measured by BROAD ACCEPTANCE SCALE
Time frame: Study period. For each interview, approximately 60 minutes.
The BAS is a 9-item questionnaire targeted to structural stigma, the "societal-level conditions, cultural norms, and institutional practices that constrain the opportunities, resources, and wellbeing" for individuals with mental illness. Each yes adds one point to the scale, and five questions from each scale were reverse-scored to match the direction of the scale. There were ten questions, therefore it generated a score between zero and ten. Higher scores indicated more acceptance and less stigma towards mental illness, while lower scores indicated less acceptance and more stigma towards mental illness.
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 10 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mental Illness and Stigma, Social, run by Yale University 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 2 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 10 Jun 2024. 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?
Level of acceptance for the individual depicted in the vignette as measured by PERSONAL ACCEPTANCE SCALE (time frame: Study period. For each interview, approximately 60 minutes.). The study lists 2 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 10 Jun 2024.