Validation of Instruments for Clinical Trial on Patients With Bipolar Disorder in Rwanda

Mental Disorder Clinical Trial

Official title:

Validation and Transcultural Adaptation of Instruments Used in a Clinical Trial on Patients With Bipolar Disorder in Rwanda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04834999
• Other study ID #: AUUR2020DKRW_4
• Status: Completed
• 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
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Participants for validation of the YMRS and the MARS:

Inclusion Criteria:

• 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:

Inclusion Criteria:

• A diagnosis of mental disorder that meets DSM-IV diagnostic criteria given by a trained psychiatrist

Participants for validation of the MDQ:

Inclusion Criteria:

• 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.

Exclusion Criteria for all participants:

• Insufficient understanding of Kinyarwanda

• Clinical evidence of substantial cognitive impairments.

Related Conditions & MeSH terms

• Bipolar Disorder
• Mental Disorder
• Mental Disorders

Intervention

Other:
• Validation of questionnaires in Kinyarwanda
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)

Locations

Country	Name	City	State
Rwanda	The University Teaching Hospital of Kigali (CHUK) and Ndera Hospital	Kigali

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Mental Health Centre Copenhagen, University of Rwanda

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ten months
Primary	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	Ten months
Primary	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.	Ten months
Primary	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	Ten months