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

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorder
• Intervention / Treatment: Other: Validation of questionnaires in Kinyarwanda

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 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.

• Study Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• Rwanda
  • Kigali, Rwanda
    • The University Teaching Hospital of Kigali (CHUK) and Ndera Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: University of Rwanda; Mental Health Centre Copenhagen
• Investigators: Study Chair: Per Kallestrup, Prof., University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mood Disorders; Bipolar and Related Disorders; Mental Disorders; Bipolar Disorder
• Other Study ID Numbers: AUUR2020DKRW_4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No