Clinical trial NCT06000059: Mental Health Stigma in Rural Uganda
Official title: Mental Health Stigma in Rural Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Empower Through Health
name: Empowerment to Heal - Uganda
First posted: 2023-08-21
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Broad Acceptance Scale (BAS)
timeFrame: baseline and 1 month post intervention, an average of 2 months
measure: Change in Personal Acceptance Scale (PAS)
timeFrame: baseline and 1 month post intervention, an average of 2 months
Secondary outcomes:
measure: Change in Broad Acceptance Scale (BAS)
timeFrame: baseline and up to one year
measure: Change in Personal Acceptance Scale (PAS)
timeFrame: baseline and up to one year
Other outcomes:
Locations:
city: Mpunde
country: Uganda
facility: Empowerment to Heal - Uganda
state: Buyende District
Study officials:
affiliation: Yale University
name: Yang Jae Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: