A cluster randomized trial for improving mental health and well-being of persons affected by leprosy or buruli ulcer in Nigeria: A study protocol.

Journal: International journal of mycobacteriology

Volume: 11

Issue: 2

Year of Publication: 2022

Affiliated Institutions:  German Leprosy and TB Relief Association, Enugu, Nigeria. Department of Community Medicine, College of Health Sciences, Ebonyi State University, Abakaliki, Nigeria. German Leprosy and TB Relief Association, Wuerzburg, Germany. Tuberculosis, Leprosy and Buruli Ulcer Control Programme, Ogbaru Local Government Area, Anambra State, Nigeria.

Abstract summary 

This protocol describes a study in which we would assess the effect of using community lay counselors, self-help groups (SHGs), and trained frontline health workers to reduce mental disorders and improve quality of life (QOL) of persons affected by leprosy or Buruli ulcer (BU). A cluster randomized controlled study design will be employed. The study will involve persons affected by leprosy or BU. Ten local government areas (clusters) with the highest number of notified leprosy or BU cases between 2014 and 2018 in Southern Nigeria will be purposively selected. The clusters will be randomized into intervention and control groups using a computer-generated list of random numbers. At baseline, data were collected using the following validated questionnaires, Patient Health Questionnaire, Generalized Anxiety Disorder questionnaire, Stigma Assessment and Reduction of Impact Scale, World Health Organization QOL BREF and Warwick-Edinburgh Mental Well-being scale among persons affected by leprosy or BU. The intervention will last for 2 years and will involve use of community lay counselors, SHGs, and appropriately trained frontline health workers in reducing mental disorders and improving QOL of persons affected by leprosy or BU. This project postulates that the reduction of burden of mental health problems and improved QOL among persons affected by leprosy or BU could be achieved through a holistic approach involving SHGs, appropriately trained community opinion leaders, and general health-care workers as well as a functional referral system. If successful, the model will be integrated into the activities of the National Tuberculosis and Leprosy Control Programme and scaled up nationwide. Trial registration: ISRCTN Registry: ISRCTN 83649248. https://trialsearch. who.int/Trial2.aspx? TrialID % ISRCTN83649248 Prospectively registered.

Authors & Co-authors:  Ekeke Ngozi N Ossai Edmund Ndudi EN Kreibich Saskia S Onyima Amaka A Chukwu Joseph J Nwafor Charles C Meka Anthony A Murphy-Okpala Ngozi N Henry Precious P Eze Chinwe C

Study Outcome 

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Statistics
Citations : 
Authors :  10
Identifiers
Doi : 10.4103/ijmy.ijmy_247_21
SSN : 2212-554X
Study Population
Male,Female
Mesh Terms
Buruli Ulcer
Other Terms
Mental health;Nigeria;persons affected by leprosy or Buruli ulcer
Study Design
Randomized Control Trial,Case Control Trial,Cross Sectional Study
Study Approach
Country of Study
Niger
Publication Country
India