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

NCT04834999 | Completed

• 1 other identifier: AUUR2020DKRW_4
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Validation of questionnaires in Kinyarwanda OTHER

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• A diagnosis of mental disorder that meets DSM-IV diagnostic criteria given by a trained psychiatrist
• Participants for validation of the MDQ:
• 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.

You may not qualify if:

• Insufficient understanding of Kinyarwanda
• Clinical evidence of substantial cognitive impairments.

Sponsors & Collaborators

• University of Aarhus: lead
• University of Rwanda: collaborator
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: collaborator

Study Sites (1)

The University Teaching Hospital of Kigali (CHUK) and Ndera Hospital

Kigali, Rwanda

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Per Kallestrup, Prof.

  University of Aarhus

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: February 15, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: November 29, 2023

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)