NCT06279962

Brief Summary

This study aims to measure levels of mental illness stigma based on condition and gender of the participants and individual portrayed with mental illness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
379

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

February 14, 2024

Last Update Submit

June 7, 2024

Conditions

Keywords

stigmamental illnesslow-income country

Outcome Measures

Primary Outcomes (2)

  • Level of acceptance for the individual depicted in the vignette as measured by PERSONAL ACCEPTANCE SCALE

    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.

    Study period. For each interview, approximately 60 minutes.

  • Level of acceptance for the individual depicted in the vignette as measured by BROAD ACCEPTANCE SCALE

    The BAS is a 9-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.

    Study period. For each interview, approximately 60 minutes.

Study Arms (8)

Experimental: V1: Woman with Major Depressive Disorder

EXPERIMENTAL

Depicting a young woman with symptomatic major depressive disorder

Other: Survey questionnaire

Experimental: V2: Man with Major Depressive Disorder

EXPERIMENTAL

Depicting a young man with symptomatic major depressive disorder

Other: Survey questionnaire

Experimental: V3: Man with Generalized Anxiety Disorder

EXPERIMENTAL

Depicting a young man with symptomatic generalized anxiety disorder

Other: Survey questionnaire

Experimental: V4: Woman with Generalized Anxiety Disorder

EXPERIMENTAL

Depicting a young woman with symptomatic generalized anxiety disorder

Other: Survey questionnaire

Experimental: V5: Woman with Schizophrenia

EXPERIMENTAL

Depicting a young woman with symptomatic schizophrenia

Other: Survey questionnaire

Experimental: V6: Man with Schizophrenia

EXPERIMENTAL

Depicting a young man with symptomatic schizophrenia

Other: Survey questionnaire

Experimental: V7: Woman with Alcohol Use Disorder

EXPERIMENTAL

Depicting a young woman with symptomatic alcohol use disorder

Other: Survey questionnaire

Experimental: V8: Man with Alcohol Use Disorder

EXPERIMENTAL

Depicting a young man with symptomatic alcohol use disorder

Other: Survey questionnaire

Interventions

The intervention is being assigned to one of the 8 different versions of the survey vignette.

Experimental: V1: Woman with Major Depressive DisorderExperimental: V2: Man with Major Depressive DisorderExperimental: V3: Man with Generalized Anxiety DisorderExperimental: V4: Woman with Generalized Anxiety DisorderExperimental: V5: Woman with SchizophreniaExperimental: V6: Man with SchizophreniaExperimental: V7: Woman with Alcohol Use DisorderExperimental: V8: Man with Alcohol Use Disorder

Eligibility Criteria

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

You may qualify if:

  • All adults who consider Buyende District their primary residence and who are capable of providing consent

You may not qualify if:

  • Minors younger than 18 years of age
  • Persons who do not consider Buyende District their primary place of residence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Empowerment to Heal - Uganda

Iganga, Uganda

Location

MeSH Terms

Conditions

Mental DisordersSocial Stigma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 28, 2024

Study Start

June 15, 2023

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

June 10, 2024

Record last verified: 2024-06

Locations