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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03656770
Other study ID # 2013P000395
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 13, 2016
Est. completion date June 8, 2018

Study information

Verified date August 2019
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Survey experiment to estimate drivers of mental illness stigma


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.


Recruitment information / eligibility

Status Completed
Enrollment 1782
Est. completion date June 8, 2018
Est. primary completion date June 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

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

Locations

Country Name City State
Uganda Mbarara University of Science and Technology Mbarara

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
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