Mental Health IssueNCT06000059
Mental Health Stigma in Rural Uganda
A study testing Radio Drama in people with Mental Health Issue, run by Yale University at 1 site in Uganda.
Trial summary
The investigators aim to elucidate attitudes and stigma towards mental illness in the pathways to mental healthcare among key stakeholders, such as traditional healers, religious leaders, families of those with mental illness, and those 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 Health Issue
- What is being tested?
- Radio Drama
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUganda
- Study dates
- 10 Aug 2023to 1 Feb 2025
- 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
- Participant must be willing to fully participate in the study - for the radio stigma intervention, it will include three separate listening sessions and two structured questionnaires. For evaluation of differential levels of stigma based on gender and condition, it will include listening to vignettes portraying mental illness and answering a questionnaire
- All members must reside in the village where the intervention is being conducted.
- Individuals must be able to provide written informed consent.
Who cannot join
- Those who cannot or are not able to willingly give consent to participate in this study will be excluded.
- Individuals who already have a family member participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to elucidate attitudes and stigma towards mental illness in the pathways to mental healthcare among key stakeholders, such as traditional healers, religious leaders, families of those with mental illness, and those with mental illness. Investigators also will measure the levels of stigma expressed by members of the general community based on gender of the individual with mental illness and the specific mental health condition. Additionally, the investigators hope to convert the previously conducted theater intervention to a radio production, which is the most commonly used form of media in Uganda, and test its effectiveness for changing attitudes and reducing stigma towards mental illness throughout society.
Read the detailed description
The scientific objective of this protocol is to develop and evaluate a novel intervention to reduce mental illness stigma among people in rural Uganda. The central hypothesis to be assessed is that a community-designed radio-based intervention can decrease mental illness stigma and lead to improved health-seeking behaviors. This hypothesis is supported by preliminary data demonstrating for the first time, to our knowledge, the effectiveness of an arts intervention to reduce mental health stigma in the general population in a rural region of a low income country. The investigators drew on message design theory underpinned by an audience-channel-message-evaluation (ACME) framework to design the intervention, a community-led theater performance in collaboration with community health workers in the rural Busoga Region of Eastern Uganda.
Radio is also popular in Uganda, with 78% of all Ugandans in rural and urban areas alike report listening to the radio. Listening to the radio is often a social activity. Adapting the ACME framework, the investigator will work with the community to convert their previously tested theater intervention into a radio intervention that can be deployed at scale.
Additionally, to better target future anti-stigma interventions, investigators will measure how the levels of stigma endorsed by the general community differ based on the mental health condition and the gender of those with mental illness.
Aim 1: Develop a radio drama derived from our previous theater intervention designed to decrease community stigma towards mental illness and increase healthcare seeking behaviors among those with mental illness.
Aim 2: Utilize qualitative methods, such as focus groups and in-depth interviews, to explore local responses to the radio drama and aspects fostering its acceptance or rejection.
Aim 3: Use a cluster randomized control trial to test the effectiveness of the radio drama in decreasing mental illness stigma immediately post-intervention and at one-month follow-up.
Aim 4: Evaluate levels of stigma endorsed by general community based on mental health condition and the gender of those with mental illness.
Hypothesis: Participants randomized to the radio drama intervention will show lower levels of mental illness stigma, compared with the control group.
The focus of this registration is Aim 3.
- Conditions
- Mental Health Issue
- Being tested
- Radio Drama
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio DramaBehavioural
An hour long radio drama adapted from from a previous community-led theater intervention
| Study group | Role | What they receive |
|---|---|---|
| Radio Drama | Experimental | Participants in this group will participate in three listening sessions. The first and third listening sessions will consist of information unrelated to mental illness. The second listening session will be the radio theater intervention that is being developed. Receives: Behavioral: Radio Drama |
| Control | No intervention | Participants in this group will participate in three listening sessions all unrelated to mental illness. |
| Randomly selected community members | No intervention | randomly selected members of the community that have not had exposure to the intervention over the course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Broad Acceptance Scale (BAS)
The BAS is a 10-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: baseline and 1 month post intervention, an average of 2 months
Change in Personal Acceptance Scale (PAS)
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: baseline and 1 month post intervention, an average of 2 months
Secondary outcomes (2)
Change in Broad Acceptance Scale (BAS)
BAS will be calculated for randomly selected community members based on the mental health condition and the gender of those with mental illness. The BAS is a 10-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: baseline and up to one year
Change in Personal Acceptance Scale (PAS)
PAS will be calculated for randomly selected community members based on the mental health condition and the gender of those with mental illness. 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: baseline and up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start10 Aug 2023
- Primary completion30 Sep 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Empower Through Health, Empowerment to Heal - Uganda
- Responsible party
- Sponsor
- Investigators
- Yang Jae Lee, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000059
- Sponsor's protocol ID
- 2000034605
- Other IDs
- No NIH funding
- Status last verified
- Jul 2026
- First submitted
- 10 Aug 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Stigma in Rural Uganda
- ClinicalTrials.gov ID
- NCT06000059
- Acronym / sponsor ID
- 2000034605
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Empower Through Health, Empowerment to Heal - Uganda
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 21 Aug 2023 (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.
The investigators aim to elucidate attitudes and stigma towards mental illness in the pathways to mental healthcare among key stakeholders, such as traditional healers, religious leaders, families of those with mental illness, and those with mental illness. Investigators also will measure the levels of stigma expressed by members of the general community based on gender of the individual with mental illness and the specific mental health condition. Additionally, the investigators hope to convert the previously conducted theater intervention to a radio production, which is the most commonly used form of media in Uganda, and test its effectiveness for changing attitudes and reducing stigma towards mental illness throughout society.
Detailed description
The scientific objective of this protocol is to develop and evaluate a novel intervention to reduce mental illness stigma among people in rural Uganda. The central hypothesis to be assessed is that a community-designed radio-based intervention can decrease mental illness stigma and lead to improved health-seeking behaviors. This hypothesis is supported by preliminary data demonstrating for the first time, to our knowledge, the effectiveness of an arts intervention to reduce mental health stigma in the general population in a rural region of a low income country. The investigators drew on message design theory underpinned by an audience-channel-message-evaluation (ACME) framework to design the intervention, a community-led theater performance in collaboration with community health workers in the rural Busoga Region of Eastern Uganda.
Radio is also popular in Uganda, with 78% of all Ugandans in rural and urban areas alike report listening to the radio. Listening to the radio is often a social activity. Adapting the ACME framework, the investigator will work with the community to convert their previously tested theater intervention into a radio intervention that can be deployed at scale.
Additionally, to better target future anti-stigma interventions, investigators will measure how the levels of stigma endorsed by the general community differ based on the mental health condition and the gender of those with mental illness.
Aim 1: Develop a radio drama derived from our previous theater intervention designed to decrease community stigma towards mental illness and increase healthcare seeking behaviors among those with mental illness.
Aim 2: Utilize qualitative methods, such as focus groups and in-depth interviews, to explore local responses to the radio drama and aspects fostering its acceptance or rejection.
Aim 3: Use a cluster randomized control trial to test the effectiveness of the radio drama in decreasing mental illness stigma immediately post-intervention and at one-month follow-up.
Aim 4: Evaluate levels of stigma endorsed by general community based on mental health condition and the gender of those with mental illness.
Hypothesis: Participants randomized to the radio drama intervention will show lower levels of mental illness stigma, compared with the control group.
The focus of this registration is Aim 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radio Drama | Experimental | Behavioral: Radio DramaParticipants in this group will participate in three listening sessions. The first and third listening sessions will consist of information unrelated to mental illness. The second listening session will be the radio theater intervention that is being developed. |
| Control | No intervention | –Participants in this group will participate in three listening sessions all unrelated to mental illness. |
| Randomly selected community members | No intervention | –randomly selected members of the community that have not had exposure to the intervention over the course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant must be willing to fully participate in the study - for the radio stigma intervention, it will include three separate listening sessions and two structured questionnaires. For evaluation of differential levels of stigma based on gender and condition, it will include listening to vignettes portraying mental illness and answering a questionnaire
- All members must reside in the village where the intervention is being conducted.
- Individuals must be able to provide written informed consent.
Key exclusion criteria (2 listed)
- Those who cannot or are not able to willingly give consent to participate in this study will be excluded.
- Individuals who already have a family member participating in the study
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 |
|---|---|---|
| Radio DramaAn hour long radio drama adapted from from a previous community-led theater intervention | Behavioural | Radio Drama |
Primary outcome
Change in Broad Acceptance Scale (BAS)
Time frame: baseline and 1 month post intervention, an average of 2 months
The BAS is a 10-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.
Change in Personal Acceptance Scale (PAS)
Time frame: baseline and 1 month post intervention, an average of 2 months
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.
2 secondary outcomes
Change in Broad Acceptance Scale (BAS)
Time frame: baseline and up to one year
Change in Personal Acceptance Scale (PAS)
Time frame: baseline and up to one year
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 23 Jul 2026.
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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 Radio Drama in people with Mental Health Issue, 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 3 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 23 Jul 2026. 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?
Change in Broad Acceptance Scale (BAS) (time frame: baseline and 1 month post intervention, an average of 2 months). 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 23 Jul 2026.