Mental DisorderNCT04834999
Validation of Instruments for Clinical Trial on Patients With Bipolar Disorder in Rwanda
An observational study of Mental Disorder, run by University of Aarhus at 1 site in Rwanda.
Trial summary
This study evaluates the cultural and linguistic sensitivity and psychometric properties of a set of four adapted measurement instruments essential to determining the efficacy of group-psychoeducation for patients with bipolar disorder in Rwanda, and one screening tool for bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Validation of questionnaires in Kinyarwanda
- How many people
- 750 participants
- Where
- 1 siteRwanda
- Study dates
- 15 Feb 2021to 15 Jul 2022
- Phase
- Observational
- 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
Study population: Participants with a mental illness will be recruited at their scheduled outpatient clinic visit, during which they complete the Kinyarwanda version of the instruments.
Who may be able to join
- Patients with a diagnosis of BD type I or II, that meets DSM-IV diagnostic criteria given by a trained psychiatrist
- Participants for validation of the ISMI-9:
- A diagnosis of mental disorder that meets DSM-IV diagnostic criteria given by a trained psychiatrist
- Participants for validation of the MDQ:
- Patient with a diagnosis of BD type I or II, or major depression that meets DSM-IV diagnostic criteria given by a trained psychiatrist
- Volunteers with no history or family history of the psychiatric disorder will be recruited as controls.
Who cannot join
- Insufficient understanding of Kinyarwanda
- Clinical evidence of substantial cognitive impairments.
Trial locations and contacts
1 site in 1 country.
Rwanda1 site
The University Teaching Hospital of Kigali (CHUK) and Ndera Hospital
Kigali
About this study
Official title: Validation and Transcultural Adaptation of Instruments Used in a Clinical Trial on Patients With Bipolar Disorder in Rwanda
This study evaluates the cultural and linguistic sensitivity and psychometric properties of a set of four adapted measurement instruments essential to determining the efficacy of group-psychoeducation for patients with bipolar disorder in Rwanda, and one screening tool for bipolar disorder. The four well-known instruments are; The Young Mania Rating Scale (YMRS), The Medical Adherence Scale (MARS), The Internalized Stigma of Mental Illness Scale-9 (ISMI-9), and the Mood disorder Questionnaire (MDQ). Each instrument will be culturally adapted and validated using a forward-backward translation, consensus conference, and cognitive interviews.
Read the detailed description
In the present study, our aim is to translate, culturally adapt and validate four used scales for use in patients with bipolar disorder. The four scales are:
- The Medical Adherence Scale (MARS), used to assess beliefs and barriers to medication adherence. The scale has 10-items, a total scores on the MARS may range between 0 and 10, with a higher score indicating better medication adherence.
- Internalized Stigma of Mental Illness Inventory - 9-item Version (ISMI-9) used to assess self-stigma. The scale consists of nine questions evaluated on a four-point Likert scale from 1 (strongly agree) to 4 (strongly disagree). The resulting score should range from 1 to 4. A score ranging between 1.00-2.50: does not report high internalized stigma vs. a score ranging between 2.51-4.00: indicating high internalized stigma
- The Young Mania Rating Scale (YMRS) is a clinical interview scale to assess the severity of manic states and has 11-items.
- The Mood Disorder Questionnaire, is a self-reported screening instrument used for identifying persons likely to have bipolar disorder. The instrument comprising a list of 13 hypomanic symptoms.
The translation and adaptation process:
One a nonprofessional translator, bilingual and knowledgeable about mental health care. The second is a translator with no particular knowledge about mental health healthcare. Following the forward translations, a meeting will be held to generate an agreed version. Next, two professional, bilingual, native English speakers back-translated the synthesized version to English. After that, an expert meeting will be held with all translators and five clinicians. Item by item, all versions, and back translations will be discussed to agree on an optimal pre-version for semantic and conceptual equivalence between the original English and the Kinyarwanda version. After that, the tools will be validated among 500 participants.
- Conditions
- Mental Disorder
- Being tested
- Validation of questionnaires in Kinyarwanda
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of questionnaires in KinyarwandaOther
Four questionnaires, three self-report instruments (Medication Adherence Rating Scale, Internalized Stigma of Mental Illness Inventory - 9-item Version and the Mood Disorder Questionnaire) and one clinical interview (the Young Mania Rating Scale)
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaption and validation of the Rwandese version of the Mood Disorder Questionnaire for screening for Bipolar Disorder
The study aims to adapt and validate the Mood Disorder Questionnaire to improve the detection of bipolar disorder in Rwanda
Measured: Ten months
Adaption and validation of the Rwandese version of the Medication Adherence Rating Scale (MARS).
The study aims to adapt and validate the Medication Adherence Rating Scale (MARS) and to access the medical adherence
Measured: Ten months
Adaption and validation of the Rwandese version of The Internalized Stigma of Mental Illness Scale-9 (ISMI-9)
The study aims to adapt and validate The Internalized Stigma of Mental Illness Scale-9 (ISMI-9) to measure the overall self-stigma of mental illness among persons with psychiatric disorders in Rwanda.
Measured: Ten months
Adaption and validation of the Rwandese version of the Young Mania Rating Scale
The study aims to adapt and validate the Young Mania Rating Scale
Measured: Ten months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 Feb 2021
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rwanda, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Responsible party
- Sponsor
- Investigators
- Per Kallestrup, Prof., Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834999
- Sponsor's protocol ID
- AUUR2020DKRW_4
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Transcultural Adaptation of Instruments Used in a Clinical Trial on Patients With Bipolar Disorder in Rwanda
- ClinicalTrials.gov ID
- NCT04834999
- Acronym / sponsor ID
- AUUR2020DKRW_4
- Conditions
- Mental Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Rwanda, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 8 Apr 2021 (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.
This study evaluates the cultural and linguistic sensitivity and psychometric properties of a set of four adapted measurement instruments essential to determining the efficacy of group-psychoeducation for patients with bipolar disorder in Rwanda, and one screening tool for bipolar disorder. The four well-known instruments are; The Young Mania Rating Scale (YMRS), The Medical Adherence Scale (MARS), The Internalized Stigma of Mental Illness Scale-9 (ISMI-9), and the Mood disorder Questionnaire (MDQ). Each instrument will be culturally adapted and validated using a forward-backward translation, consensus conference, and cognitive interviews.
Detailed description
In the present study, our aim is to translate, culturally adapt and validate four used scales for use in patients with bipolar disorder. The four scales are:
- The Medical Adherence Scale (MARS), used to assess beliefs and barriers to medication adherence. The scale has 10-items, a total scores on the MARS may range between 0 and 10, with a higher score indicating better medication adherence.
- Internalized Stigma of Mental Illness Inventory - 9-item Version (ISMI-9) used to assess self-stigma. The scale consists of nine questions evaluated on a four-point Likert scale from 1 (strongly agree) to 4 (strongly disagree). The resulting score should range from 1 to 4. A score ranging between 1.00-2.50: does not report high internalized stigma vs. a score ranging between 2.51-4.00: indicating high internalized stigma
- The Young Mania Rating Scale (YMRS) is a clinical interview scale to assess the severity of manic states and has 11-items.
- The Mood Disorder Questionnaire, is a self-reported screening instrument used for identifying persons likely to have bipolar disorder. The instrument comprising a list of 13 hypomanic symptoms.
The translation and adaptation process:
One a nonprofessional translator, bilingual and knowledgeable about mental health care. The second is a translator with no particular knowledge about mental health healthcare. Following the forward translations, a meeting will be held to generate an agreed version. Next, two professional, bilingual, native English speakers back-translated the synthesized version to English. After that, an expert meeting will be held with all translators and five clinicians. Item by item, all versions, and back translations will be discussed to agree on an optimal pre-version for semantic and conceptual equivalence between the original English and the Kinyarwanda version. After that, the tools will be validated among 500 participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a mental illness will be recruited at their scheduled outpatient clinic visit, during which they complete the Kinyarwanda version of the instruments.
Key inclusion criteria (6 listed)
- Patients with a diagnosis of BD type I or II, that meets DSM-IV diagnostic criteria given by a trained psychiatrist
- A diagnosis of mental disorder that meets DSM-IV diagnostic criteria given by a trained psychiatrist
- Patient with a diagnosis of BD type I or II, or major depression that meets DSM-IV diagnostic criteria given by a trained psychiatrist
- Volunteers with no history or family history of the psychiatric disorder will be recruited as controls.
Key exclusion criteria (2 listed)
- Insufficient understanding of Kinyarwanda
- Clinical evidence of substantial cognitive impairments.
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 |
|---|---|---|
| Validation of questionnaires in KinyarwandaFour questionnaires, three self-report instruments (Medication Adherence Rating Scale, Internalized Stigma of Mental Illness Inventory - 9-item Version and the Mood Disorder Questionnaire) and one clinical interview (the Young Mania Rating Scale) | Other | – |
Primary outcome
Adaption and validation of the Rwandese version of the Mood Disorder Questionnaire for screening for Bipolar Disorder
Time frame: Ten months
The study aims to adapt and validate the Mood Disorder Questionnaire to improve the detection of bipolar disorder in Rwanda
Adaption and validation of the Rwandese version of the Medication Adherence Rating Scale (MARS).
Time frame: Ten months
The study aims to adapt and validate the Medication Adherence Rating Scale (MARS) and to access the medical adherence
Adaption and validation of the Rwandese version of The Internalized Stigma of Mental Illness Scale-9 (ISMI-9)
Time frame: Ten months
The study aims to adapt and validate The Internalized Stigma of Mental Illness Scale-9 (ISMI-9) to measure the overall self-stigma of mental illness among persons with psychiatric disorders in Rwanda.
Adaption and validation of the Rwandese version of the Young Mania Rating Scale
Time frame: Ten months
The study aims to adapt and validate the Young Mania Rating Scale
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 29 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Per Kallestrup, Prof. study chair
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder, run by University of Aarhus at 1 site in Rwanda.
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 6 inclusion and 2 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 29 Nov 2023. 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 Rwanda. 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?
Adaption and validation of the Rwandese version of the Mood Disorder Questionnaire for screening for Bipolar Disorder (time frame: Ten months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.