- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06000059
Mental Health Stigma in Rural Uganda
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yang Jae Lee, MD
- Phone Number: 706-691-9813
- Email: yangjae.lee@yale.edu
Study Locations
-
-
Buyende District
-
Mpunde, Buyende District, Uganda
- Recruiting
- Empowerment to Heal - Uganda
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Radio Drama
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.
|
An hour long radio drama adapted from from a previous community-led theater intervention
|
|
No Intervention: Control
Participants in this group will participate in three listening sessions all unrelated to mental illness.
|
|
|
No Intervention: Randomly selected community members
randomly selected members of the community that have not had exposure to the intervention over the course
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline and 1 month post intervention, an average of 2 months
|
|
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.
|
baseline and 1 month post intervention, an average of 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Broad Acceptance Scale (BAS)
Time Frame: baseline and up to one year
|
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.
|
baseline and up to one year
|
|
Change in Personal Acceptance Scale (PAS)
Time Frame: baseline and up to one year
|
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.
|
baseline and up to one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yang Jae Lee, MD, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2000034605
- No NIH funding (Other Identifier: 11.09.23)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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