NCT03656770

Brief Summary

Survey experiment to estimate drivers of mental illness stigma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,782

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

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

December 13, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

August 29, 2018

Last Update Submit

August 8, 2019

Conditions

Mental IllnessSchizophreniaBipolar DisorderDepression

Outcome Measures

Primary Outcomes (6)

  • Social Distance

    Willingness to have the woman portrayed in the vignette to marry into the study participant's family (single item culturally adapted instrument developed specifically for this study)

    Immediate (assessed with respect to the study participant's beliefs at a single time point, which is the time at which the survey is administered)

  • Perceived Norms about Social Distance

    Study participant's perception of the extent to which other people would be willing to have the woman portrayed in the vignette to marry into their families (single item culturally adapted instrument developed specifically for this study)

    Immediate (assessed with respect to the study participant's beliefs at a single time point, which is the time at which the survey is administered)

  • Negative Attitudes (Attribution)

    Personal belief that the symptoms of the woman portrayed in the vignette represent divine punishment (single item culturally adapted instrument developed specifically for this study)

    Immediate (assessed with respect to the study participant's beliefs at a single time point, which is the time at which the survey is administered)

  • Perceived Norms about Negative Attitudes (Attribution)

    Study participant's perception of the extent to which other people believe that the symptoms of the woman portrayed in the vignette represent divine punishment (single item culturally adapted instrument developed specifically for this study)

    Immediate (assessed with respect to the study participant's beliefs at a single time point, which is the time at which the survey is administered)

  • Negative Attitudes (Shame)

    Personal belief that the symptoms of the woman portrayed in the vignette bring shame upon her family

    Immediate (assessed with respect to the study participant's beliefs at a single time point, which is the time at which the survey is administered)

  • Perceived Norms about Negative Attitudes (Shame)

    Study participant's perception of the extent to which other people believe that the symptoms of the woman portrayed in the vignette bring shame upon her family (single item culturally adapted instrument developed specifically for this study)

    Immediate (assessed with respect to the study participant's beliefs at a single time point, which is the time at which the survey is administered)

Study Arms (10)

V1: Control

NO INTERVENTION

This version of the survey questionnaire depicts a young woman with no symptoms of mental illness.

V2: Schizophrenia

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young woman with untreated and symptomatic schizophrenia.

Other: Survey questionnaire

V3: Schizophrenia + Tx with Response

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young woman with schizophrenia, successfully treated with complete response.

Other: Survey questionnaire

V4: Schizophrenia + Tx with Relapse

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young woman with schizophrenia, successfully treated with partial relapse.

Other: Survey questionnaire

Version 5: Bipolar

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young woman with untreated and symptomatic bipolar disorder.

Other: Survey questionnaire

V6: Bipolar + Tx with Response

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young woman with bipolar disorder, successfully treated with complete response.

Other: Survey questionnaire

V7: Bipolar + Tx with Relapse

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young woman with bipolar disorder, successfully treated with partial relapse.

Other: Survey questionnaire

V8: Depression

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young woman with untreated and symptomatic major depressive disorder.

Other: Survey questionnaire

V9: Depression + Tx with Response

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young woman with major depressive disorder, successfully treated with complete response.

Other: Survey questionnaire

V10: Depression + Tx with Relapse

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young woman with major depressive disorder, successfully treated with partial relapse.

Other: Survey questionnaire

Interventions

Survey questionnaireOTHER

Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.

V10: Depression + Tx with RelapseV2: SchizophreniaV3: Schizophrenia + Tx with ResponseV4: Schizophrenia + Tx with RelapseV6: Bipolar + Tx with ResponseV7: Bipolar + Tx with RelapseV8: DepressionV9: Depression + Tx with ResponseVersion 5: Bipolar

Eligibility Criteria

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

You may qualify if:

  • all persons who considered Nyakabare Parish their primary place of residence and who were capable of providing consent

You may not qualify if:

  • minors younger than 18 years of age, with the exception of emancipated minors
  • persons who did not consider Nyakabare their primary place of residence, e.g., persons who happened to be visiting Nyakabare at the time of the survey or who owned a home in Nyakabare but spent most of their time outside the parish
  • persons with whom research staff could not communicate, e.g., due to deafness, mutism, or aphasia
  • persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which were determined informally in the field by non-clinical research staff in consultation with a supervisor)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

Related Publications (1)

  • Rasmussen JD, Kakuhikire B, Baguma C, Ashaba S, Cooper-Vince CE, Perkins JM, Bangsberg DR, Tsai AC. Portrayals of mental illness, treatment, and relapse and their effects on the stigma of mental illness: Population-based, randomized survey experiment in rural Uganda. PLoS Med. 2019 Sep 20;16(9):e1002908. doi: 10.1371/journal.pmed.1002908. eCollection 2019 Sep.

    PMID: 31539373DERIVED

MeSH Terms

Conditions

Mental DisordersSchizophreniaBipolar DisorderDepression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Alexander C Tsai, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 4, 2018

Study Start

December 13, 2016

Primary Completion

June 8, 2018

Study Completion

June 8, 2018

Last Updated

August 12, 2019

Record last verified: 2019-08

Locations

UG(1)