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

NCT04834999 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 750

Last updated 2023-11-29

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • University of Rwanda

    collaborator OTHER

  • Mental Health Services in the Capital Region, Denmark

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Per Kallestrup, Prof. · University of Aarhus

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2022-07-15
Completion
2022-07-15

Countries

  • Rwanda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04834999 on ClinicalTrials.gov