Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04834999 |
Other study ID # |
AUUR2020DKRW_4 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 15, 2021 |
Est. completion date |
July 15, 2022 |
Study information
Verified date |
April 2021 |
Source |
University of Aarhus |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
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Clinical 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. 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.
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:
1. 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.
2. 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
3. The Young Mania Rating Scale (YMRS) is a clinical interview scale to assess the severity
of manic states and has 11-items.
4. 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.