An observational study in Mental Disorder, sponsored by University of Aarhus. Completed at 1 site in Rwanda. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by University of Aarhus · Observational
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.
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 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.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's enrollment of 750 is above the median of 160 across 329 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants with a mental illness will be recruited at their scheduled outpatient clinic visit, during which they complete the Kinyarwanda version of the instruments.
Participants for validation of the YMRS and the MARS:
Inclusion Criteria:
Participants for validation of the ISMI-9:
Inclusion Criteria:
Participants for validation of the MDQ:
Inclusion Criteria:
Exclusion Criteria for all participants:
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)
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Ten months
Plan to share: No
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of Aarhus