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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1782

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Uganda
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings