Back to resultsMeasuring Beliefs and Norms About Persons With Mental Illness
Primary Purpose
Mental Illness, Schizophrenia, Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Survey questionnaire
Sponsored by
About this trial
This is an interventional other trial for Mental Illness
Eligibility Criteria
Inclusion Criteria:
- all persons who considered Nyakabare Parish their primary place of residence and who were capable of providing consent
Exclusion Criteria:
- 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)
Sites / Locations
- Mbarara University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm Type
No Intervention
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
V1: Control
V2: Schizophrenia
V3: Schizophrenia + Tx with Response
V4: Schizophrenia + Tx with Relapse
Version 5: Bipolar
V6: Bipolar + Tx with Response
V7: Bipolar + Tx with Relapse
V8: Depression
V9: Depression + Tx with Response
V10: Depression + Tx with Relapse
Arm Description
This version of the survey questionnaire depicts a young woman with no symptoms of mental illness.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
Negative Attitudes (Shame)
Personal belief that the symptoms of the woman portrayed in the vignette bring shame upon her family
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03656770
First Posted
August 29, 2018
Last Updated
August 8, 2019
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03656770
Brief Title
Measuring Beliefs and Norms About Persons With Mental Illness
Official Title
Measuring Beliefs and Norms About Persons With Mental Illness in Rural Uganda: A Randomized Survey Experiment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 13, 2016 (Actual)
Primary Completion Date
June 8, 2018 (Actual)
Study Completion Date
June 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Survey experiment to estimate drivers of mental illness stigma
Detailed Description
Despite significant advances in scientific understanding of brain and substance use disorders accompanied by significant advances in treatment and improvements in prognosis, mental illness remains highly stigmatized throughout the world. Previous studies suggest that portraying mental illness as treatable can reduce negative attitudes toward persons with mental illness. This randomized controlled trial compares the effects of exposing study participants to vignettes portraying persons with untreated and symptomatic mental illness vs. treated mental illness with complete response vs. treated mental illness with relapse. It is hypothesized, based on prior work, that study participants exposed to vignettes depicting treated mental illness with completed response would have the greatest effect on reducing negative attitudes toward persons with mental illness, followed by treated mental illness with relapse and untreated and symptomatic mental illness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness, Schizophrenia, Bipolar Disorder, Depression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1782 (Actual)
8. Arms, Groups, and Interventions
Arm Title
V1: Control
Arm Type
No Intervention
Arm Description
This version of the survey questionnaire depicts a young woman with no symptoms of mental illness.
Arm Title
V2: Schizophrenia
Arm Type
Experimental
Arm Description
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.
Arm Title
V3: Schizophrenia + Tx with Response
Arm Type
Experimental
Arm Description
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.
Arm Title
V4: Schizophrenia + Tx with Relapse
Arm Type
Experimental
Arm Description
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.
Arm Title
Version 5: Bipolar
Arm Type
Experimental
Arm Description
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.
Arm Title
V6: Bipolar + Tx with Response
Arm Type
Experimental
Arm Description
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.
Arm Title
V7: Bipolar + Tx with Relapse
Arm Type
Experimental
Arm Description
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.
Arm Title
V8: Depression
Arm Type
Experimental
Arm Description
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.
Arm Title
V9: Depression + Tx with Response
Arm Type
Experimental
Arm Description
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.
Arm Title
V10: Depression + Tx with Relapse
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Survey questionnaire
Intervention Description
Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.
Primary Outcome Measure Information:
Title
Social Distance
Description
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)
Time Frame
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)
Title
Perceived Norms about Social Distance
Description
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)
Time Frame
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)
Title
Negative Attitudes (Attribution)
Description
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)
Time Frame
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)
Title
Perceived Norms about Negative Attitudes (Attribution)
Description
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)
Time Frame
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)
Title
Negative Attitudes (Shame)
Description
Personal belief that the symptoms of the woman portrayed in the vignette bring shame upon her family
Time Frame
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)
Title
Perceived Norms about Negative Attitudes (Shame)
Description
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)
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all persons who considered Nyakabare Parish their primary place of residence and who were capable of providing consent
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander C Tsai, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbarara University of Science and Technology
City
Mbarara
Country
Uganda
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31539373
Citation
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.
Results Reference
derived
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Measuring Beliefs and Norms About Persons With Mental Illness
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