Mental IllnessNCT06509386
Effects of Portrayals of Successful Treatment and Role Fulfillment on Mental Illness Stigma
A study testing Major Depressive Disorder without treatment or role fulfillment, Major Depressive Disorder with treatment but no role fulfillment and Major Depressive Disorder without treatment but with role fulfillment in people with Mental Illness, run by Yale University at 1 site in Uganda.
Trial summary
This study aims to measure levels of mental illness stigma based on successful treatment and societal role fulfillment of the 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
- What is being tested?
- Major Depressive Disorder without treatment or role fulfillment, Major Depressive Disorder with treatment but no role fulfillment and Major Depressive Disorder without treatment but with role fulfillment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUganda
- Study dates
- 15 Jun 2024to 15 Aug 2024
- 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: Randomized Vignette Experiment on the Effects of Portrayals of Successful Treatment and Role Fulfillment on Mental Illness Stigma
This study aims to measure levels of mental illness stigma based on successful treatment and societal role fulfillment of the individual portrayed with mental illness.
Read the detailed description
This study aims to measure levels of mental illness stigma based on successful treatment and societal role fulfillment of the individual portrayed with mental illness. This study utilizes eight vignettes portraying two different mental illnesses (depression and schizophrenia), with one vignette giving no details about role fulfillment or treatment, another giving no details about role fulfillment but successful treatment, another giving details on role fulfillment but no treatment, and last giving details on both role fulfillment and successful treatment.
- Conditions
- Mental Illness
- Being tested
- Major Depressive Disorder without treatment or role fulfillment, Major Depressive Disorder with treatment but no role fulfillment, Major Depressive Disorder without treatment but with role fulfillment, Major Depressive Disorder with treatment and role fulfillment, Schizophrenia without treatment or role fulfillment
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major Depressive Disorder without treatment or role fulfillmentOther
Read vignette describing the condition and ask stigma questions.
Major Depressive Disorder with treatment but no role fulfillmentOther
Read vignette describing the condition and ask stigma questions.
Major Depressive Disorder without treatment but with role fulfillmentOther
Read vignette describing the condition and ask stigma questions.
Major Depressive Disorder with treatment and role fulfillmentOther
Read vignette describing the condition and ask stigma questions.
Schizophrenia without treatment or role fulfillmentOther
Read vignette describing the condition and ask stigma questions.
Schizophrenia with treatment but no role fulfillmentOther
Read vignette describing the condition and ask stigma questions.
Schizophrenia without treatment but with role fulfillmentOther
Read vignette describing the condition and ask stigma questions.
Schizophrenia with treatment and role fulfillmentOther
Read vignette describing the condition and ask stigma questions.
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder without treatment or role fulfillment | Experimental | Not described Receives: Other: Major Depressive Disorder without treatment or role fulfillment |
| Major Depressive Disorder with treatment but no role fulfillment | Experimental | Not described Receives: Other: Major Depressive Disorder with treatment but no role fulfillment |
| Major Depressive Disorder without treatment but with role fulfillment | Experimental | Not described Receives: Other: Major Depressive Disorder without treatment but with role fulfillment |
| Major Depressive Disorder with treatment and role fulfillment | Experimental | Not described Receives: Other: Major Depressive Disorder with treatment and role fulfillment |
| Schizophrenia without treatment or role fulfillment | Experimental | Not described Receives: Other: Schizophrenia without treatment or role fulfillment |
| Schizophrenia with treatment but no role fulfillment | Experimental | Not described Receives: Other: Schizophrenia with treatment but no role fulfillment |
| Schizophrenia without treatment but with role fulfillment | Experimental | Not described Receives: Other: Schizophrenia without treatment but with role fulfillment |
| Schizophrenia with treatment and role fulfillment | Experimental | Not described Receives: Other: Schizophrenia with treatment and role fulfillment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Acceptance Scale (PAS)
The PAS is a 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. 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: One year. For each interview, approximately 60 minutes.
Broad Acceptance Scale (BAS)
The BAS is a questionnaire targeted to distal public stigma. 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: One year. For each interview, approximately 60 minutes.
Attributed Stigma Scale
Attributed stigma scale will be a modification of the PAS to gather understanding of what participants believe the attitudes of others in their community are. 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: One year. 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 posted19 Jul 2024
- Study start15 Jun 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Jae Lee, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509386
- Sponsor's protocol ID
- 2000034605_b
- Status last verified
- Jan 2025
- First submitted
- 7 Jun 2024
- Last updated
- 28 Jan 2025
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Vignette Experiment on the Effects of Portrayals of Successful Treatment and Role Fulfillment on Mental Illness Stigma
- ClinicalTrials.gov ID
- NCT06509386
- Acronym / sponsor ID
- 2000034605_b
- Conditions
- Mental Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 19 Jul 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 successful treatment and societal role fulfillment of the individual portrayed with mental illness.
Detailed description
This study aims to measure levels of mental illness stigma based on successful treatment and societal role fulfillment of the individual portrayed with mental illness. This study utilizes eight vignettes portraying two different mental illnesses (depression and schizophrenia), with one vignette giving no details about role fulfillment or treatment, another giving no details about role fulfillment but successful treatment, another giving details on role fulfillment but no treatment, and last giving details on both role fulfillment and successful treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder without treatment or role fulfillment | Experimental | Other: Major Depressive Disorder without treatment or role fulfillment |
| Major Depressive Disorder with treatment but no role fulfillment | Experimental | Other: Major Depressive Disorder with treatment but no role fulfillment |
| Major Depressive Disorder without treatment but with role fulfillment | Experimental | Other: Major Depressive Disorder without treatment but with role fulfillment |
| Major Depressive Disorder with treatment and role fulfillment | Experimental | Other: Major Depressive Disorder with treatment and role fulfillment |
| Schizophrenia without treatment or role fulfillment | Experimental | Other: Schizophrenia without treatment or role fulfillment |
| Schizophrenia with treatment but no role fulfillment | Experimental | Other: Schizophrenia with treatment but no role fulfillment |
| Schizophrenia without treatment but with role fulfillment | Experimental | Other: Schizophrenia without treatment but with role fulfillment |
| Schizophrenia with treatment and role fulfillment | Experimental | Other: Schizophrenia with treatment and role fulfillment |
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 |
|---|---|---|
| Major Depressive Disorder without treatment or role fulfillmentRead vignette describing the condition and ask stigma questions. | Other | Major Depressive Disorder without treatment or role fulfillment |
| Major Depressive Disorder with treatment but no role fulfillmentRead vignette describing the condition and ask stigma questions. | Other | Major Depressive Disorder with treatment but no role fulfillment |
| Major Depressive Disorder without treatment but with role fulfillmentRead vignette describing the condition and ask stigma questions. | Other | Major Depressive Disorder without treatment but with role fulfillment |
| Major Depressive Disorder with treatment and role fulfillmentRead vignette describing the condition and ask stigma questions. | Other | Major Depressive Disorder with treatment and role fulfillment |
| Schizophrenia without treatment or role fulfillmentRead vignette describing the condition and ask stigma questions. | Other | Schizophrenia without treatment or role fulfillment |
| Schizophrenia with treatment but no role fulfillmentRead vignette describing the condition and ask stigma questions. | Other | Schizophrenia with treatment but no role fulfillment |
| Schizophrenia without treatment but with role fulfillmentRead vignette describing the condition and ask stigma questions. | Other | Schizophrenia without treatment but with role fulfillment |
| Schizophrenia with treatment and role fulfillmentRead vignette describing the condition and ask stigma questions. | Other | Schizophrenia with treatment and role fulfillment |
Primary outcome
Personal Acceptance Scale (PAS)
Time frame: One year. For each interview, approximately 60 minutes.
The PAS is a 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. 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.
Broad Acceptance Scale (BAS)
Time frame: One year. For each interview, approximately 60 minutes.
The BAS is a questionnaire targeted to distal public stigma. 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.
Attributed Stigma Scale
Time frame: One year. For each interview, approximately 60 minutes.
Attributed stigma scale will be a modification of the PAS to gather understanding of what participants believe the attitudes of others in their community are. 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 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Yang Jae Lee, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Major Depressive Disorder without treatment or role fulfillment, Major Depressive Disorder with treatment but no role fulfillment and Major Depressive Disorder without treatment but with role fulfillment in people with Mental Illness, 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 28 Jan 2025. 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?
Personal Acceptance Scale (PAS) (time frame: One year. For each interview, approximately 60 minutes.). The study lists 3 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 28 Jan 2025.