NCT06000059

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

August 10, 2023

Last Update Submit

January 27, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    baseline and 1 month post intervention, an average of 2 months

Secondary Outcomes (2)

  • Change in Broad Acceptance Scale (BAS)

    baseline and up to one year

  • Change in Personal Acceptance Scale (PAS)

    baseline and up to one year

Study Arms (3)

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.

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

Interventions

Radio DramaBEHAVIORAL

An hour long radio drama adapted from from a previous community-led theater intervention

Radio Drama

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Empowerment to Heal - Uganda

Mpunde, Buyende District, Uganda

RECRUITING

Study Officials

  • Yang Jae Lee, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Jae Lee, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 21, 2023

Study Start

August 10, 2023

Primary Completion

September 30, 2024

Study Completion

August 30, 2025

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations