Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04834999
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2021-04-06
Brief Title:
Validation of Instruments for Clinical Trial on Patients With Bipolar Disorder in Rwanda
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Validation and Transcultural Adaptation of Instruments Used in a Clinical Trial on Patients With Bipolar Disorder in Rwanda
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 100-250 does not report high internalized stigma vs a score ranging between 251-400 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
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 100-250 does not report high internalized stigma vs a score ranging between 251-400 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None