Mental IllnessNCT03656770
Measuring Beliefs and Norms About Persons With Mental Illness
A study testing Survey questionnaire in people with Mental Illness and Schizophrenia, run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
Survey experiment to estimate drivers of mental illness stigma Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Illness, Schizophrenia, Bipolar Disorder
- What is being tested?
- Survey questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,782 participants
- Where
- 1 siteUganda
- Study dates
- 13 Dec 2016to 8 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all persons who considered Nyakabare Parish their primary place of residence and who were capable of providing consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Mental Illness, Schizophrenia, Bipolar Disorder, Depression
- Being tested
- Survey questionnaire
- Medical subject headings
- Mental Disorders, Schizophrenia, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey questionnaireOther
Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.
| Study group | Role | What they receive |
|---|---|---|
| V1: Control | No intervention | This version of the survey questionnaire depicts a young woman with no symptoms of mental illness. |
| V2: Schizophrenia | Experimental | 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. Receives: Other: Survey questionnaire |
| V3: Schizophrenia + Tx with Response | Experimental | 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. Receives: Other: Survey questionnaire |
| V4: Schizophrenia + Tx with Relapse | Experimental | 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. Receives: Other: Survey questionnaire |
| Version 5: Bipolar | Experimental | 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. Receives: Other: Survey questionnaire |
| V6: Bipolar + Tx with Response | Experimental | 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. Receives: Other: Survey questionnaire |
| V7: Bipolar + Tx with Relapse | Experimental | 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. Receives: Other: Survey questionnaire |
| V8: Depression | Experimental | 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. Receives: Other: Survey questionnaire |
| V9: Depression + Tx with Response | Experimental | 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. Receives: Other: Survey questionnaire |
| V10: Depression + Tx with Relapse | Experimental | 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. Receives: Other: Survey questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
Personal belief that the symptoms of the woman portrayed in the vignette bring shame upon her family
Measured: 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)
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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start13 Dec 2016
- Primary completion8 Jun 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Tsai, Massachusetts General Hospital
- Investigators
- Alexander C Tsai, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656770
- Sponsor's protocol ID
- 2013P000395
- Status last verified
- Aug 2019
- First submitted
- 29 Aug 2018
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31539373
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Beliefs and Norms About Persons With Mental Illness in Rural Uganda: A Randomized Survey Experiment
- ClinicalTrials.gov ID
- NCT03656770
- Acronym / sponsor ID
- 2013P000395
- Conditions
- Mental Illness, Schizophrenia, Bipolar Disorder, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,782 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 8 Jun 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| V1: Control | No intervention | –This version of the survey questionnaire depicts a young woman with no symptoms of mental illness. |
| V2: Schizophrenia | Experimental | Other: Survey questionnaireAs 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. |
| V3: Schizophrenia + Tx with Response | Experimental | Other: Survey questionnaireAs 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. |
| V4: Schizophrenia + Tx with Relapse | Experimental | Other: Survey questionnaireAs 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. |
| Version 5: Bipolar | Experimental | Other: Survey questionnaireAs 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. |
| V6: Bipolar + Tx with Response | Experimental | Other: Survey questionnaireAs 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. |
| V7: Bipolar + Tx with Relapse | Experimental | Other: Survey questionnaireAs 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. |
| V8: Depression | Experimental | Other: Survey questionnaireAs 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. |
| V9: Depression + Tx with Response | Experimental | Other: Survey questionnaireAs 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. |
| V10: Depression + Tx with Relapse | Experimental | Other: Survey questionnaireAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all persons who considered Nyakabare Parish their primary place of residence and who were capable of providing consent
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey questionnaireEach version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response. | Other | V10: Depression + Tx with Relapse, V2: Schizophrenia, V3: Schizophrenia + Tx with Response, V4: Schizophrenia + Tx with Relapse, V6: Bipolar + Tx with Response, V7: Bipolar + Tx with Relapse, V8: Depression, V9: Depression + Tx with Response, Version 5: Bipolar |
Primary outcome
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)
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)
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)
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)
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Derived from this study: PubMed 31539373Rasmussen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander C Tsai, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey questionnaire in people with Mental Illness and Schizophrenia, run by Massachusetts General Hospital at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03656770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.