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Measuring Beliefs and Norms About Persons With Mental Illness

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ClinicalTrials.gov Identifier: NCT03656770
Recruitment Status : Completed
First Posted : September 4, 2018
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Alexander Tsai, Massachusetts General Hospital

Brief Summary:
Survey experiment to estimate drivers of mental illness stigma

Condition or disease Intervention/treatment Phase
Mental Illness Schizophrenia Bipolar Disorder Depression Other: Survey questionnaire Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1782 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Measuring Beliefs and Norms About Persons With Mental Illness in Rural Uganda: A Randomized Survey Experiment
Actual Study Start Date : December 13, 2016
Actual Primary Completion Date : June 8, 2018
Actual Study Completion Date : June 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
No Intervention: V1: Control
This version of the survey questionnaire depicts a young woman with no symptoms of mental illness.
Experimental: V2: 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 untreated and symptomatic schizophrenia.
Other: Survey questionnaire
Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.

Experimental: V3: Schizophrenia + Tx with 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 complete response.
Other: Survey questionnaire
Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.

Experimental: V4: Schizophrenia + Tx with 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 schizophrenia, successfully treated with partial relapse.
Other: Survey questionnaire
Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.

Experimental: Version 5: Bipolar
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
Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.

Experimental: V6: Bipolar + Tx with 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 complete response.
Other: Survey questionnaire
Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.

Experimental: V7: Bipolar + Tx with 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 bipolar disorder, successfully treated with partial relapse.
Other: Survey questionnaire
Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.

Experimental: V8: Depression
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
Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.

Experimental: V9: Depression + Tx with 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 complete response.
Other: Survey questionnaire
Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.

Experimental: V10: Depression + Tx with 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 major depressive disorder, successfully treated with partial relapse.
Other: Survey questionnaire
Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.




Primary Outcome Measures :
  1. Social Distance [ 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) ]
    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)

  2. Perceived Norms about Social Distance [ 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) ]
    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)

  3. Negative Attitudes (Attribution) [ 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) ]
    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)

  4. Perceived Norms about Negative Attitudes (Attribution) [ 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) ]
    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)

  5. Negative Attitudes (Shame) [ 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) ]
    Personal belief that the symptoms of the woman portrayed in the vignette bring shame upon her family

  6. Perceived Norms about Negative Attitudes (Shame) [ 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) ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656770


Locations
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Uganda
Mbarara University of Science and Technology
Mbarara, Uganda
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Alexander C Tsai, MD Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alexander Tsai, Associate Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03656770    
Other Study ID Numbers: 2013P000395
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders