Mental Health Stigma in Rural Uganda

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06000059
Collaborator
Empowerment to Heal - Uganda (Other)
350
1
2
4.7
75

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Radio Drama
N/A

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.12 We drew on message design theory underpinned by an audience-channel-message-evaluation (ACME) framework to design the intervention,13 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 reporting that they listen 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.

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.

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

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Mental Health Stigma in Rural Uganda
Actual Study Start Date :
Aug 10, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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.

Behavioral: Radio Drama
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.

Outcome Measures

Primary Outcome Measures

  1. Change in Broad Acceptance Scale (BAS) [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.

  2. Change in Personal Acceptance Scale (PAS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Participant must be willing to fully participate in the study, which will include three separate listening sessions and two structured questionnaires.

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Empowerment to Heal - Uganda Mpunde Buyende District Uganda

Sponsors and Collaborators

  • Yale University
  • Empowerment to Heal - Uganda

Investigators

  • Principal Investigator: Yang Jae Lee, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT06000059
Other Study ID Numbers:
  • 2000034605
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 21, 2023