- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03656770
Measuring Beliefs and Norms About Persons With Mental Illness
August 8, 2019 updated by: Alexander Tsai, Massachusetts General Hospital
Measuring Beliefs and Norms About Persons With Mental Illness in Rural Uganda: A Randomized Survey Experiment
Survey experiment to estimate drivers of mental illness stigma
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1782
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mbarara, Uganda
- Mbarara University of Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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
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)
|
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)
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)
|
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)
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)
|
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)
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
|
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)
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)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2016
Primary Completion (Actual)
June 8, 2018
Study Completion (Actual)
June 8, 2018
Study Registration Dates
First Submitted
August 29, 2018
First Submitted That Met QC Criteria
August 30, 2018
First Posted (Actual)
September 4, 2018
Study Record Updates
Last Update Posted (Actual)
August 12, 2019
Last Update Submitted That Met QC Criteria
August 8, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013P000395
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Bekelu Teka WorkuJimma UniversityNot yet recruitingPrenatal Depression | Mental Health Related Quality of Life | Maternal Postpartum Depression | Paternal Postpartum DepressionEthiopia
Clinical Trials on Survey questionnaire
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH); Mbarara University of Science and...Completed
-
M.D. Anderson Cancer CenterCompleted
-
Frederiksberg University HospitalTerminated
-
First Affiliated Hospital of Wenzhou Medical UniversityQilu Hospital of Shandong University; Eastern Hepatobiliary Surgery Hospital; The First Affiliated Hospital of Zhejiang Chinese Medical UniversityEnrolling by invitationEfficacy | Liver Cancer | Adverse Event | Microbiota | PrognosisChina
-
Second Affiliated Hospital, School of Medicine,...Enrolling by invitation
-
Samsung Medical CenterActive, not recruitingOccupational Diseases | Emergency DepartmentsKorea, Republic of
-
Stanford UniversityCompletedBreast CancerUnited States
-
Peking University Third HospitalCompleted
-
M.D. Anderson Cancer CenterCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)UnknownGlioma | Brain TumorUnited States, Finland, Sweden, Denmark, Israel, United Kingdom