Reassessing the Significance of Mycobacterium in Neglected Tropical Diseases: A Study Protocol in Nigeria

Abstract

Background: 

Neglected tropical diseases (NTDs) significantly impact the physical and mental well-being of affected individuals, particularly in Nigeria. This study aims to evaluate the effectiveness of integrating mental health services with self-care practices for individuals suffering from leprosy, Buruli ulcer (BU), and lymphatic filariasis (LF). The role of trained Healthcare Workers (HCWs) and NTD champions (NTD-Cs) will be explored to enhance health outcomes in this population.

Methods: 

A cluster-randomized controlled trial was conducted in four local government areas (clusters) with the highest incidence of leprosy, BU, or LF. Clusters were purposively selected and randomized into intervention and control groups: three clusters received interventions, while one served as a control. The intervention arms include (a) Mental health and self-care interventions by NTD-Cs. (b) Mental health and self-care interventions by HCWs. (c) Self-care interventions only by HCWs. d) Control group receiving standard care. Data were collected at baseline and postintervention using validated questionnaires, including the Patient Health Questionnaire and World Health Organization Quality of Life (QOL-BREF), among others. The intervention will last for 8 months, with monthly self-help group meetings providing support and resources.

Results: 

The study aims to provide evidence on the effectiveness of integrated mental health and self-care interventions for NTD patients by evaluating outcomes such as mental health status, quality of life (QOL), and socioeconomic factors.

Conclusion: 

This trial aims to inform policy and practice by demonstrating the potential benefits of integrating mental health services within the care framework for individuals affected by NTDs in Nigeria. If successful, the findings will contribute to the enhancement of healthcare delivery and may be incorporated into the National Tuberculosis and Leprosy Control Program for broader implementation across the country.

Trial registration: PACTR Registration number: PACTR202404852537141.

https://pactr.samrc.ac.za/Default.aspx?Logout=True

Retrospectively registered.

INTRODUCTION

Neglected tropical diseases (NTDs) encompass a variety of diseases and conditions that prevail in tropical and subtropical areas.^[1,2] More than one billion people are affected by these diseases, with prevalence rates differing among the 47 member states in the World Health Organization (WHO) African Region. Leprosy (Hansen’s disease), Buruli ulcer (BU), and lymphatic filariasis (LF) are part of the WHO’s list of NTDs.^[2] These diseases disproportionately impact populations living in poverty. Because they lack strong political motivation and priorities for health resources, NTDs have been overlooked in the global health agenda over the past decades.^[3] The significance of NTDs as diseases of poverty has been consistently recognized in the global public health agenda over the past three decades. Currently, NTD control is part of the Sustainable Development Goals, with item 3 of goal 3 aiming to end NTD epidemics by 2030.^[4]

Buruli ulcer (BU) is caused by the bacterium Mycobacterium ulcerans. It has been reported in over 30 countries across different continents, with most cases being reported from the West African region.^[5] Leprosy, also known as Hansen’s disease, is caused by an obligatory intracellular Mycobacterium leprae.^[6] LF is an NTD caused by Wuchereria bancrofti.^[7] NTDs are also linked to significant deformity and disability, contributing to the pool of global disability-adjusted life years.^[8] This link of NTDs with disabilities and various forms of impairments results to rejection, stigma, and discrimination, which severely impacts the mental health, quality of life (QOL), and functionality of the persons affected.^[9] Evidence shows that there is a need for chemotherapy, wound care, prevention of physical impairment and disability, as well as psychosocial support for persons affected by these diseases.^[10] Since individuals with these disorders are more likely to experience mental health issues, it is imperative that a comprehensive strategy be used in the treatment of these patients.

In 2020, the WHO published a guidance titled “Mental health of people with NTDs–toward a person-centered approach,” acknowledging the importance of mental health in those affected by cutaneous NTDs.^[11] The mental health needs of people with skin NTDs have not, however, been adequately met by low- and middle-income countries (LMIC) not introduced health systems yet. Over 85% of individuals in LMICs who suffer from serious mental health issues do not have access to appropriate care, and they frequently experience stigma and prejudice from society.^[12] In the last 10 years, research on NTDs has placed a strong emphasis on mental health.^[13,14] Recent studies have shown a strong relationship between NTDs, particularly leprosy, to mental health conditions and reduced QOL.^[15-17] A study in Plateau State, Nigeria revealed that depression is highly prevalent among individuals with LF, and those affected often experience low self-esteem and reduced life satisfaction.^[18] Another study in North-western Nigeria showed that clinical factors are strongly linked to depression and anxiety in individuals with leprosy.^[19] This also reiterates how crucial mental health services are for people with leprosy to ensure a holistic approach to their management and care.

Research indicates that participation in self-help groups (SHGs) by individuals with mental health disorders improves their QOL and self-esteem.^[10] There is a huge gap in the delivery of mental health services in Nigeria. According to estimates, there are presently 40:1,000,000 psychiatric nurses and one psychiatrist for every million people. Furthermore, the distribution of available specialists is heavily skewed in favor of urban locations.^[9]

Due to this unmet need for mental health services caused by the shortage of mental health experts, it is necessary to investigate practical and efficient solutions. The country NTD master plan 2021–2025 and the NTDs, Nigeria multi-year master plan both described the need to focus on reducing morbidity, disability, and mortality of NTDs using integrated and cost-effective approaches.^[20] The NTD Master Plan identified several gaps, including limited capacity and an insufficient number of staff to effectively supervise and monitor community-level activities, as well as a lack of operational research to address program challenges. The priorities in the plan include comprehensive capacity building of NTD staff and volunteers at all levels on integrated NTDs as well as conducting operational research to improve NTD program performance.^[20] This study aims to address the identified gaps by introducing mental health into integrated service delivery, a novel approach proposed by this project.

This project will identify eligible “NTD champions” (NTD-Cs) that will undergo capacity building and be engaged to serve as skilled local trainers and project cluster coordinators. The innovation is to task-shift essential NTD services to NTD-Cs. These are persons affected by NTDs who are willing and are able to share their lived experiences on a volunteer basis. They will coordinate SHG meetings, help train participants on self-care practices, provide basic psychotherapy for the participants who need it and refer cases to mental health experts. The project seeks to compare the outcome of mental health and self-care practices between SHGs coordinated by NTD-Cs and those coordinated by trained HCWs. The project also intends to use integrated SHGs of persons affected by leprosy, LF, and BU to provide peer counseling and self-care. These approaches are aimed at providing the lack of mental health services to persons affected by leprosy, BU, and LF at the community level. Should the concept prove effective, it will be incorporated into the National Tuberculosis and Leprosy Control Program (NTBLCP) and scaled up nationwide.

Primary objective

To ascertain the effectiveness, acceptability, and feasibility of providing both mental health and self-care interventions in an integrated approach to improve the QOL, social inclusion, and reduce disability and healthcare costs for families affected by leprosy, BU, and LF.

Secondary objectives

1. To compare the outcomes of self-care and mental health interventions coordinated by healthcare workers (HCWs) and NTD-Cs
2. To evaluate if an integrated self-care group alone (without mental health services) can improve the mental health status of individuals affected by NTDs
3. To explore sustainable approaches to strengthen the healthcare system through community participation, aiming to improve the quality of care for NTD patients
4. To assess the feasibility of integrating both mental health services and self-care practices
5. To evaluate the acceptability of integrated services to beneficiaries – individuals affected by NTDs (leprosy, BU, or LF)
6. To determine the extent to which the integrated approach contributes to the improvement of mental health and QOL for individuals with NTDs (leprosy, BU, or LF)
7. To compare the effectiveness of services facilitated by NTD-Cs with those facilitated by HCWs.

METHODS

Ethical statement

The Helsinki Declaration of 1975, as amended in 2000 for Human Research of the World Medical Association,^[21] was followed in conducting the research. Ethical approval for the study was obtained from the Health Research Ethics Committee of the University of Nigeria Teaching Hospital Ituku-Ozalla, Enugu. Approval number (NHREC/05/01-2008B-FWA00002458-IRB00002323).

Patient consent statement

Informed consent is a fundamental principle that forms the foundation of the protections for human subjects involved in research.^[22] The consent form explicitly states the right of the participant to refuse to give consent or withdraw from the study at any point. Furthermore, he/she can decline to answer any question. Informed consent was obtained from each participant prior to participation. Each participant was given a copy of the participant’s information and signed consent form to keep. The confidentiality of any information submitted through the questionnaire was guaranteed.

Respondents will be informed that the research findings aim to enhance understanding of the physical, mental, and overall well-being of individuals affected by NTDs. They will also be assured that their participation poses no associated risks.

Type of sampling and reason of selection

The study will utilize a combination of retrospective and snowball sampling methods. Retrospective sampling was used to recruit participants from routine surveillance data, ensuring the inclusion of individuals already diagnosed with leprosy, BU, or LF. Local Government TB and Leprosy Supervisors (LGA TBLS) and LGA NTD coordinators were asked to list the names and contacts of persons affected by leprosy, BU, or LF from the corresponding LGA (district) registers. Snowball sampling was used to reach individuals who may not have sought formal healthcare services. The participants were contacted either physically or via phone call. In addition, persons affected by NTDs in the communities who may not have sought help at the health facilities could be reached through community-based actors such as Community Directed Distributors. Persons so identified may reach others with similar problems, resulting in a positive snowballing effect. This approach will ensure a comprehensive sample, including both recorded and unrecorded cases, thereby enhancing the representativeness of the study population.

Inclusion criteria

• Persons affected by leprosy, BU, or LF, including children with Grade 2 disability, category III BU lesions, BU complications such as contractures, and other conditions (who need self-care).
• Family members of persons affected by NTDs who give consent to participate.
• Persons affected by NTDs who are willing to learn and practice self-care.

Exclusion criteria

• Persons who are unable to participate due to severe illness.

Nigeria is a nation in West Africa that shares borders with the Niger Republic to the north, the Republic of Chad and Cameroun to the east, the Republic of Benin to the west, and the Atlantic Ocean to the south. The country is located between latitudes 4°1ʹ and 13°9ʹ North and longitudes 2°2ʹ and 14°30ʹ East, with a total surface area of 923, 768 km² and 800 km of coastline. With a population of 218.5 million, Nigeria is composed of 36 states, which are further divided into 774 local government areas (LGAs), which is the third tier of governance. The Federal Capital Territory (FCT) is located in Abuja.

In 1988, the Federal Ministry of Health in Nigeria launched the NTBLCP. Originally tasked with controlling leprosy and tuberculosis, the NTBLCP later included BU in its purview. In 2019, Africa accounted for 10% (20,205) of the global leprosy cases, with Nigeria and 12 other countries reporting between 1000 and 10,000 cases. Even though the WHO’s 1998 target of fewer cases of leprosy per 10,000 people was met, high endemicity areas still exist in a few states and LGAs around the nation. This study will be conducted in Abia, Enugu, and Ondo States of Nigeria.^[23,24]

Study design

This study is a four-arm cluster randomized trial involving three intervention arms and a control arm. The first two intervention arms will be provided with mental health and self-care interventions but randomly allocated to either HCWs or NTD-Cs. However, the 3^rd arm will involve integrated NTDs with self-care interventions similar to the first two but without any mental health interventions. The 4^th arm, which serves as control, will be a “leprosy only” cluster (depicting the current “standard of care” in Nigeria). The four purposively selected study clusters are namely Oji River (Enugu State), Bende (Abia State), Aninri (Enugu State), and Akure South (Ondo State) LGAs, which are areas with co-endemicity of NTDs. Baseline assessment for mental health and QOL, clinical assessment for morbidity management, cost of healthcare, and disability status will be conducted for all participants in the four clusters. This will be followed by monthly SHG meetings involving self-care practice, peer support, psychosocial counseling, and referral for individuals in the intervention sites. At the end of the intervention, an endline assessment will be conducted to measure the effect of the intervention. In addition, qualitative assessment of feasibility, acceptability, and effectiveness of self-care practices through Focus Group Discussions (FGDs) of persons affected by NTDs and Key Informant Interviews (KIIs) of NTD-Cs and HCWs at baseline and endline will also be carried out in the four clusters.

Study population

About 50 eligible persons affected by NTDs will be recruited in each of the three intervention arms, and 30 in the control arm, making a total of 180 study participants. About five integrated SHGs will be established in each study arm, with an average of 10 persons affected by NTDs in each SHG. Local SHG facilitators who are community members not affected by NTDs will be recruited and trained to directly support the respective SHG operations under the overall supervision of either the HCWs or NTD-Cs in charge of the cluster. The project will ensure gender equity and inclusion of persons with disability in the selection of the SHG facilitators.

Sample size

All eligible persons were recruited in an ongoing basis into the SHGs over the initial period of 6 months. We estimate a total of 50 persons affected by leprosy, LF, or BU to be recruited per intervention cluster, i.e. Intervention Arm A = 50; Intervention Arm B = 50, and Intervention Arm C = 50. However, 30 persons affected by leprosy will be recruited in the Control Arm D (standard of care), where all participants are only persons affected by leprosy. This gives a total of 180 persons affected by NTDs who will participate in the study.

Study duration

The study duration was October 1, 2022, to June 30, 2024.

Data collection

Mental health assessment for persons affected by NTDs will be done using the Patient Health Questionnaire (PHQ-9) for depression. QOL and disability status was assessed using WHOQOL-BREF and WHO Disability Assessment Schedule (WHODAS), respectively, while the Rosenburg self-esteem scale (RSS) was used to assess self-esteem. A pretested questionnaire will be used to assess the socioeconomic status of persons. These data were collected at baseline and endline. Patient record cards were used to document baseline, formative phase, and endline findings of clinical assessment and monitoring of skin lesions (ulcer, edema, scar tissues, contractures) of persons affected by NTDs. The intervention groups and control groups were compared after the intervention to determine the change in mental health status, QOL, economic burden, and social participation of study participants.

Data quality was guaranteed by:

• Training and supervision of research assistants
• Use of digital data collection.

Description of Intervention:

• As shown in Figure 1, This intervention involves several phases.

• 

  Figure 1: Intervention pathway towards improving mental health of persons affected by neglected tropical diseases (Developed by the Researchers)

• The intervention will be implemented in four purposively selected NTD-endemic LGAs, with the highest number of notified leprosy cases in 2021 across Abia, Ondo, and Enugu States. These are Bende, Akure South, Aninri, and Oji River LGAs
• Randomization of interventions will be done to determine which of the LGAs (clusters) will be coordinated by health workers, NTD-Cs or serve as Control “standard of care”
• Integrated SHG of persons affected will be established in two out of four clusters and provided with similar interventions – mental health and self-care trainings, project monitoring, and supervision of SHG participants
• Integrated NTD groups will be established in the third intervention arm and provided with self-care trainings, project monitoring, and supervision. However, no mental health intervention will be provided in this group
• The fourth arm with “leprosy only” which is the current standard of care in Nigeria, will serve as the control group, and no interventions will be carried out in this arm
• Selected HCWs and NTD-Cs will be provided with the same training and support on the provision of mental health services as well as self-care practices in the first and second intervention arms (Arm-A and Arm-B). However, HCWs in the third arm will not be trained on the delivery of mental health services
• After the training, the project will ensure that only those (health workers or NTD-Cs) who demonstrate a satisfactory understanding of the intervention will be engaged to participate in the study
• Staff supervision and project monitoring/evaluation visits will be regularly provided across all intervention clusters by the project.

Preparatory phase

• Ethical approval will be obtained from approved ethical review boards before implementation
• To secure buy-in and ownership, advocacy meetings with policymakers will be held at the Federal, State, and LGA levels
• Stakeholders’ implementation meetings will be held with the Central Unit of National Tuberculosis, Leprosy and BU Control Program and NTDs Program of the Federal Ministry of Health
• Sensitization meetings with the Association of Persons affected by leprosy and local health authorities in the project LGAs will be carried out prior to project implementation
• Consultation with Purple Hope Initiative of Nigeria, a national NGO of women and children affected by Hansen’s disease (leprosy), community gatekeepers, and local health authorities will be held to finalize study protocols.

Formative phase

• Recruitment of facilitators – HCWs and NTD-C
• Establishment of SHGs
• Training of and engagement of study arm coordinators/facilitators (HCWs, NTD-C, and SHG participants) on mental health and self-care interventions
• Baseline assessment for mental health and QOL, clinical assessment for morbidity management, cost of healthcare, disability status
• Baseline qualitative data collection (FGDs with SHGS) to ascertain feasibility, acceptance and effectiveness of intervention. KII with NTD-Cs and HCWs
• Clinical assessment, recording, and reporting of the status of skin lesions (ulcers, edema, scars, and contractures) of persons affected by leprosy, BU, or LF will be carried out at baseline and endline by NTD-Cs and HCWs, as well as the independent observer who will be masked to the assessments by the NTD-Cs/HCWs,

Intervention phase

• Clinical assessment, recording, and reporting of skin lesions and mental health status by NTD-Cs/HCWs at baseline, monthly, and at endline.
• Self-care practices at home and/or clinic will be monitored through patient home record cards by NTD-Cs/HCWs
• Mental health assessment (for depression) using PHQ-9 to establish levels of depression among persons affected by NTDs (leprosy, BU, and LF) at baseline, formative, and endline
• Quantitative assessment of QOL, disability status, cost of care, and mental well-being of persons affected by NTDs at baseline and endline using WHOQOL-BREF, WHODAS
• Qualitative assessment of feasibility, acceptability, and effectiveness of self-care practices through FGDs of person affected by NTDs and KIIs of NTD-Cs and HCWs at baseline and endline
• Monthly SHG meetings: Peer support and experience sharing on coping mechanisms by members of established, joint SHGs of persons affected by leprosy, BU, or LF
• SHGs for NTDs will provide regular opportunities for sharing of ideas, feelings, and information with other patients. Effective communication within group members will be enhanced by promoting respect for each other’s ideas and beliefs while learning from the experience of others
• Psychosocial counseling will be provided for persons affected by NTDs with mental disorders (especially depression) by trained NTD-Cs or HCWs
• Pharmacological treatment and/or referral to mental health experts (psychiatrists or clinical psychologists) by trained frontline HCWs and NTD-Cs in the community primary healthcare (PHC) settings
• Regular supervision, monitoring, and evaluation of self-care activities in SHGs by NTD-Cs and HCWs
• Both health workers and NTD-Cs will have access to referral services to mental health experts when necessary
• The intervention period will be for 8 months.

Project coordinators/facilitators

Neglected tropical diseases champions

For the purposes of this study, NTD-Cs are defined as persons affected by leprosy, BU, or LF who have lived experience and are self-motivated to provide care and support to other persons affected by NTDs. They should be willing and able to share their lived experience (including stigma, discrimination, and social exclusion as well as coping mechanisms), and do so on a voluntary basis. The expected minimum educational level should be at least secondary education.

• Persons affected by leprosy and other NTDs and/or HCWs involved in NTDs will be requested to nominate or recommend suitably qualified persons who will serve as NTDCs. Only 10 persons out of those recommended will be trained and best five eventually engaged/recruited to serve as NTD-Cs per cluster. This is a quality assurance process to ensure optimal engagement of human resources for health
• Five NTD-Cs will be engaged per cluster, and others will be on the reserve list to replace those who might no longer be available at any point in the project, to minimize the internal risks. Five NTDCs will coordinate cluster activities, which serve about 50 persons affected by NTDs
• The job description of the NTD-Cs will include: facilitating group meetings, assessment of mental health status, providing counseling to persons with mental disorders, arranging referrals to higher levels of mental health care, clinical assessment of skin lesions, and documentation of findings in monitoring cards, train persons affected on self-care (for edema, ulcers, scar tissues and contractures) and provide regular supervision to the patients on self-care
• HCWs: A person with basic healthcare training, either as Nurse, Community Health Officer, or its equivalent, employed/deployed as a frontline worker in the PHC system to provide healthcare services. Recruitment of HCWs will be done through the respective LGA TB, Leprosy and BU Supervisors and NTD Focal Persons. A total of 15 health workers serving within the locality of persons affected by NTDs will be selected for training and five best performing HCWs engaged per cluster. Their job description is similar to those of NTD-Cs. Similar to the NTD-Cs, the HCWs will be provided with a monthly allowance for communication and lunch throughout the intervention phase.

Conceptual framework

NTDs are diseases linked to disability and impairments. This may result in low self-esteem, which, when combined with discrimination, will enable the person to remain in isolation. In the absence of self-care practices, the mental health, QOL and self-esteem of the persons will be affected.

It is anticipated that the intervention, which will involve SHGs, NTD-Cs, and HCWs providing psychosocial and self-care interventions, will work in synergy to improve the mental health, QOL, and self-esteem of persons affected by NTDs.

RESULTS

The study recruited a total of 180 participants, with approximately 50 individuals affected by leprosy, BU, or LF in each of the three intervention arms (A, B, and C) and 30 in the control group (Arm D). The selection will focus on individuals who meet the inclusion criteria, ensuring a representative sample of the affected population in the four purposively selected LGAs of Abia, Enugu, and Ondo states.

Demographic characteristics

At baseline, data were collected on the demographic characteristics of participants, including age, gender, educational background, socioeconomic status, and duration of illness. We anticipate that the majority of participants were adults, with a balanced representation of genders. Socioeconomic factors were assessed using a pre-tested questionnaire designed to capture household income, employment status, and access to healthcare services.

Baseline assessments

Prior to the intervention, baseline assessments were conducted to evaluate the mental health status and QOL of all participants. The following validated instruments were utilized:

• PHQ-9: This tool measured the severity of depressive symptoms, providing a score that ranges from 0 to 27, with higher scores indicating greater levels of depression
• WHO QOL-BREF: This instrument assessed participants’ overall QOL across various domains including physical health, psychological health, social relationships, and environmental factors
• RSS: This scale measured self-esteem levels, providing insights into the participants’ self-perception and confidence
• WHODAS: This tool evaluated the functional abilities and disabilities of participants, focusing on their capacity to perform daily activities
• Morbidity Management and Disability Prevention Card: This was used to document specific conditions and disabilities related to NTDs, allowing for tailored interventions.

Statistical analysis

Data analysis will be performed using the IBM Statistical Package for Social Sciences (SPSS, IBM Corporation, Armonk, New York, United States) version 25. A significance level of P < 0.05 will be set for all statistical tests. We will summarize demographic data and baseline characteristics using means, standard deviations, frequencies, and percentages. The effectiveness of the interventions was assessed using Analysis of Variance (ANOVA) to compare mean scores across the four arms for each outcome variable (mental health, QOL, self-esteem, and disability). Tukey’s HSD post-hoc test was conducted to identify specific group differences when ANOVA results are significant.

Paired t-tests were utilized to evaluate changes in outcome measures from baseline to postintervention within each study arm.

Pearson’s correlation coefficient was calculated to explore relationships between variables, such as the association between PHQ-9 scores and self-esteem levels.

DISCUSSION

The context of this study is critical, as NTDs continue to pose significant public health challenges, particularly in LMICs like Nigeria.^[1] These diseases not only lead to physical morbidity but also have profound psychological impacts, contributing to social stigma and reduced QOL among affected individuals.^[9] This research aims to address these dual challenges by integrating mental health services with self-care practices for individuals affected by leprosy, BU, and LF. The findings from this study have the potential to influence health policies and practices, fostering a more holistic approach to the management of NTDs. The integration of mental health into the care framework for NTDs is essential for several reasons. First, individuals affected by NTDs often experience high levels of psychological distress, including depression and anxiety. Research has shown that the prevalence of mental health disorders is significantly higher among individuals with NTDs compared to the general population.^[10] For instance, studies indicate that individuals with leprosy and LF frequently report depressive symptoms, which can exacerbate their physical health conditions and hinder recovery. Second, mental health issues can lead to social isolation, stigma, and discrimination, further compounding the challenges faced by affected individuals. By addressing mental health needs alongside physical health, the proposed interventions seek to reduce stigma, promote social inclusion, and enhance overall well-being. This integrated approach aligns with the WHO’s emphasis on person-centered care, which prioritizes the needs and preferences of individuals in health service delivery. The study anticipates several key outcomes, each with significant implications for the management of NTDs and the well-being of affected individuals. One of the primary expected outcomes is a significant decrease in depressive symptoms among participants in the intervention arms. If successful, this finding would underscore the importance of mental health interventions in holistic care models and provide evidence to support the integration of mental health services into existing healthcare frameworks for NTDs, influencing policy decisions at both local and national levels. Participants are also expected to report enhanced QOL following the interventions. This improvement is crucial, as it reflects not only physical health gains but also psychological and social enhancements. Improved QOL scores could serve as a compelling argument for incorporating mental health services into routine care for NTD patients, demonstrating the broader benefits of such interventions. In addition, the anticipated increase in self-esteem among participants highlights the role of social support and empowerment in recovery. SHGs and peer support mechanisms can provide individuals with a sense of belonging and purpose. This finding could encourage the establishment of more community-based support programs, leveraging the lived experiences of individuals affected by NTDs to foster resilience and recovery. Improvements in functional capacity, as measured by WHODAS scores, would indicate that the integrated approach effectively enhances the ability of individuals to perform daily activities, which is particularly important for individuals with NTDs, as functional limitations can severely impact their QOL and independence. If the intervention proves effective, it could lead to the development of tailored rehabilitation programs that address specific functional impairments associated with NTDs. Demonstrating that mental health and self-care interventions can reduce the economic burden on families affected by NTDs would strengthen the case for increased investment in mental health services within NTD management. However, several challenges may arise in the implementation of the integrated model, and identifying and addressing these barriers is crucial for the success and sustainability of the interventions. Despite the anticipated benefits, stigma surrounding mental health and NTDs may hinder participation in the study and the acceptance of mental health services. Individuals may fear being labeled or discriminated against, which could deter them from seeking support. To mitigate this, the study will incorporate strategies to raise awareness about mental health and reduce stigma, including community sensitization and education campaigns. The availability of trained healthcare professionals and NTD-Cs is vital for the successful implementation of the interventions. In many regions, there may be a shortage of mental health professionals, which could limit the reach and effectiveness of the proposed model. Training local community health workers and leveraging the expertise of NTD-Cs will be essential in overcoming this barrier. Furthermore, cultural beliefs and practices may influence individuals’ perceptions of mental health and the acceptance of integrated care. It is crucial to consider cultural contexts when designing and implementing interventions. Engaging community leaders and stakeholders in the planning process can help ensure that the interventions are culturally sensitive and resonate with the target population. For the integrated approach to be effective in the long term, strategies must be developed to ensure the sustainability of mental health services within the healthcare system. This may involve advocating for policy changes to allocate resources for mental health and integrating these services into existing NTD programs. The findings from this study could have significant implications for health policy in Nigeria and beyond. As the WHO emphasizes the need for integrated care models, the evidence generated by this research can support advocacy efforts to incorporate mental health services into the national health agenda for NTDs. Policymakers may be more inclined to allocate resources and develop comprehensive strategies that address both physical and mental health needs if the study demonstrates the effectiveness of integrated interventions. Moreover, this study could serve as a model for similar initiatives in other regions facing comparable challenges. By providing a framework for integrating mental health into NTD management, the research can inspire other countries to adopt holistic approaches to healthcare, ultimately improving outcomes for marginalized populations affected by NTDs. While this study focuses on specific NTDs, future research could expand the scope to include other neglected diseases and health conditions. Understanding the mental health implications of various diseases can help create comprehensive care strategies that address the diverse needs of affected populations. In addition, longitudinal studies could provide insights into the long-term effects of integrated interventions on mental health and QOL. Investigating the sustainability of such interventions over time would be valuable for developing effective health policies and programs. Overall, this study aims to address a key gap in NTD management by integrating mental health services with self-care practices. The anticipated outcomes have the potential to significantly enhance the well-being of individuals affected by leprosy, BU, and LF. By demonstrating the effectiveness of this integrated approach, the study could influence health policies, promote social inclusion, and reduce the stigma associated with NTDs. Ultimately, the successful implementation of integrated mental health and self-care interventions can transform the landscape of NTD management, fostering a more holistic and person-centered approach to health care. As the global health community continues to strive for the elimination of NTDs, the insights gained from this research may serve as a catalyst for change, improving the lives of millions affected by these diseases.

CONCLUSION

This study aims to provide critical insights into the integration of mental health services and self-care practices for individuals affected by NTDs in Nigeria. By utilizing a cluster-randomized controlled trial design, we will rigorously assess the effectiveness of interventions facilitated by trained HCWs and NTD-Cs. The anticipated outcomes, including improvements in mental health, QOL, and socioeconomic status, will offer valuable evidence to inform health policy and practice.

The findings of this research have the potential to reshape the approach to care for NTD patients by emphasizing a holistic model that addresses both physical and psychological needs. If proven effective, the integrated model will be a significant advancement in the management of NTDs and could be adopted into the NTBLCP, ultimately improving healthcare delivery for affected populations across Nigeria. This initiative aims to improve individual well-being while also working to reduce the stigma surrounding NTDs, thereby promoting a more supportive community environment.

Outcome of the study

The primary aim of the study was to assess the effectiveness of the integrated interventions on mental health and QOL. Expected changes are categorized as following outcomes:

Mental health improvement

• A significant reduction in PHQ-9 scores from baseline to post-intervention for both Arm A (NTD-Cs) and Arm B (HCWs) was anticipated. It is projected that participants receiving mental health support alongside self-care practices reported fewer depressive symptoms.

Quality of life enhancement

Improvements in WHO QOL-BREF scores are anticipated, indicating better physical and psychological health, improved social relationships, and enhanced environmental support. We hypothesize that the integrated interventions will lead to a statistically significant increase in QOL scores, particularly in intervention arms compared to the control.

Self-esteem changes

An increase in RSS scores indicated improved self-esteem among participants in the intervention groups. We expect that the psychosocial support provided through SHGs will foster a sense of belonging and self-worth.

Functional capacity

WHODAS scores were analyzed to determine changes in disability levels and functional capacity. We predicted that participants in the intervention arms will demonstrate improved functioning in daily activities, reflecting the effectiveness of self-care practices.

Economic Impact: Economic burden assessments will provide insights into healthcare costs and resource utilization. The integrated approach is expected to alleviate the economic burden on families affected by NTDs, as evidenced by reduced healthcare expenses reported after the intervention.

Rational of the Study

NTDs such as leprosy, BU, and LF not only cause physical impairments but also deeply affect the mental health and social inclusion of those impacted.^[9] The chronic nature of these diseases, coupled with the stigma, rejection, and discrimination faced by affected individuals, leads to significant psychological distress, which is often overlooked in healthcare interventions.^[10] Despite evidence pointing to the need for holistic care, including both mental health support and physical rehabilitation, most interventions for NTDs in LMICs have focused primarily on treating the physical manifestations of these diseases.

Research shows that persons affected by NTDs are at a higher risk of mental health conditions such as depression, anxiety, and low self-esteem. However, mental health services are grossly inadequate in LMICs, particularly in rural areas, where the majority of NTD cases are found. This shortage of mental health professionals and the limited accessibility of mental health services create significant gaps in the care provided to individuals affected by NTDs. This unmet need calls for innovative, community-based solutions that can offer integrated care addressing both physical and mental health needs.

This study seeks to address these gaps by employing a novel approach that integrates mental health services into self-care practices for persons affected by NTDs. By leveraging the involvement of NTD-Cs–individuals with lived experiences of NTDs–as peer counselors and coordinators, the project aims to provide comprehensive care at the community level. The use of SHGs, facilitated by both trained HCWs and NTD-Cs, will not only offer peer support and self-care education but also deliver basic mental health interventions, thereby improving the overall well-being and QOL for affected individuals.

By evaluating the effectiveness of these interventions, this study seeks to contribute to the development of sustainable, scalable models of care that integrate mental health and physical health services for individuals affected by NTDs. This approach aligns with the priorities outlined in Nigeria’s NTD Master Plan and could serve as a framework for future national strategies to improve the care and well-being of NTD patients.

Limitations of the study

Considering the duration of the intervention period, attrition among study participants is a possibility. It is possible for some people to relocate. There could also be the possibility of social desirability bias on the part of the respondents. The research team will explain the objectives of the study to the respondents, assuring the participants of the confidentiality of information and also ensuring that no identifiers are included during the process of data collection.

Financial support and sponsorship

Effect Hope Canada and German Leprosy and TB Relief Association (DAHW Germany).

Conflicts of interest

There are no conflicts of interest.