Improving the mental health and wellbeing of people affected by leprosy or Buruli ulcer in Nigeria
| ISRCTN | ISRCTN83649248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83649248 |
| Secondary identifying numbers | 708.20.15/LRI |
- Submission date
- 02/03/2021
- Registration date
- 18/03/2021
- Last edited
- 04/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Leprosy and Buruli ulcer (BU) are infectious diseases that co-exist in many states across Nigeria. Both are diseases of public health importance and are often associated with high levels of stigma and discrimination owing to their tendency to cause visible deformities.
Mental health services in Nigeria suffer from multiple gaps. It is estimated that there is only one mental health expert for hundreds of thousands of inhabitants. In view of the dearth of mental health professionals coupled with a skewed distribution of professionals in favour of the cities as well as poor budgetary allocation by the government, there is a need to explore sustainable ways to make mental health services accessible to those in dire need, especially persons affected by leprosy and BU.
Some studies and projects have been undertaken to assess the burden of mental health problems especially depression among persons with various NTDs as well as appropriate ways to address them. Some of the findings are quite promising. They show that a community-oriented approach run by trained laypersons (without specialist mental health background) with appropriate supervision, can improve access to effective, acceptable and cost-effective mental health services. The study aims to determine the impact of a community-oriented, holistic approach on the mental health status (especially, depression and generalized anxiety disorder) and the quality of life among persons affected by leprosy or Buruli ulcer in Southern Nigeria.
Who can participate?
People affected by leprosy or BU in southern Nigeria, especially those registered for treatment from 2014 up to 1 year before the end of the intervention. It essentially includes those aged between 15 to 65 years who agree to participate. Moreover, participants will be selected from the 10 LGAs with the highest number of leprosy/BU patients in southern Nigeria. The states and local government areas (LGAs) are Anambra State (Anambra East and Ogbaru LGAs), Akwa Ibom State (Etinan LGA), Bayelsa State (Ogbia LGA), Cross River State (Ogoja, Obubra and Calabar South LGAs), Delta State (Ethiope East and Isoko South LGAs) and Ebonyi State (Ebonyi LGA).
What does the study involve?
This study has a dual objective: to determine the burden/extent of mental illness (especially depression) among persons affected by leprosy or BU and ascertain whether a holistic (multi-layered) community-oriented approach involving patient self-help groups, lay community counsellors and non-specialist health workers improves the mental health and well-being of leprosy/BU patients in southern Nigeria. It is believed that the use of self-help groups (SHG), lay community counsellors and trained health workers will reinforce and complement each other in a synergistic manner, resulting in better outcomes to approaches based on health workers alone.
Advocacy visits to relevant groups will follow the ethical approval of the project from appropriate authorities. A baseline survey will be conducted to ascertain the burden of mental health problems among leprosy or Buruli ulcer patients using appropriate research tools. Social discrimination against persons affected by leprosy or Buruli ulcer by community members will also be measured at the preliminary stage of the project. Self-help groups will be established to provide an enabling platform for peer-support through regular interactions/meetings, reduce self-stigma and promote self-esteem among patients. Selected community opinion leaders will be trained as lay-counsellors to provide counselling for patients identified to have depression or anxiety and promote social participation. Trained health workers will ensure effective treatment and/or adequate referral services for patients. At the end of the project, patients will be re-assessed to determine any difference in their mental health status and quality of life.
What are the possible benefits and risks of participating?
Participants will be actively involved in self-help groups with others who may have suffered similar psychological and emotional trauma due to stigma and social discrimination. Peer-interaction and experience sharing by other patients might remarkably give hope to people who are depressed and restore self-esteem and mental well-being. Community leaders who serve as counsellors might go further to defend the human rights of persons affected by leprosy and BU through the platform of self-help groups. Similarly, healthcare workers involved alongside community leaders in some of the self-help group meetings will provide mental health services where necessary to participants. However, participants may suffer the risk of having their disease status disclosed to other participants and facilitators in order to receive the necessary help.
Where is the study run from?
German Leprosy and TB Relief Association (Nigeria)
When is the study starting and how long is it expected to run for?
July 2020 to December 2023
Who is funding the study?
Leprosy Research Initiative (LRI)
Who is the main contact?
Ngozi Ekeke
ekekengozi@gmail.com, ngozi.ekeke@dahw.org
Contact information
Public
German Leprosy and TB Relief Association
56 Nza Street, Independence Layout
Enugu
400241
Nigeria
| Phone | +234 (0)8035076274 |
|---|---|
| ngozi.ekeke@dahw.org |
Scientific
German Leprosy and TB Relief Association
56 Nza Street, Independence Layout
Enugu
400241
Nigeria
| Phone | +234 (0)8035076274 |
|---|---|
| ngozi.ekeke@dahw.org |
Study information
| Study design | Cluster-randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | ISRCTN83649248_PIS.pdf |
| Scientific title | Improving the mental health and quality of life of people affected by leprosy or Buruli ulcer in Southern Nigeria |
| Study objectives | A community-oriented, holistic approach improves the mental health (depression and generalized anxiety disorder) status and the quality of life of people affected by leprosy or Buruli ulcer in Southern Nigeria. |
| Ethics approval(s) | Approved 27/08/2020, Health Research and Ethics Committee, University of Nigeria Teaching Hospital (Ituku-Ozalla, Enugu, P.M.B. 01129, Enugu, Nigeria; +234 (0)42-252022, 252573, 252172, 252134; cmdunth2019@gmail.com), ref: NHREC/05/01/2008B-FWA00002458-1RB00002323 |
| Health condition(s) or problem(s) studied | Mental health and quality of life of persons affected by leprosy or Buruli ulcer |
| Intervention | The study proposes a holistic, community-oriented approach for improving access and utilization of mental health services through interventions using holistic approach work synergistically to reduce mental disorders and improve quality of life among persons affected by leprosy or Buruli ulcer, viz: 1. Engaging selected community members as lay counsellors to provide psychotherapy and counselling services for persons affected by leprosy or Buruli ulcer 2. Formation of self-help groups (SHG) among persons affected by leprosy or Buruli ulcer for peer support and improving self-esteem 3. Training of healthcare workers to provide pharmacological treatment or referral services to experts where necessary The intervention phase will take about 1 - 2 years with quarterly community sensitization during supervisory visits by the research team to promote social inclusion, raise awareness on mental health problems and availability of services to create demand and enhance utilization. Re-training of service providers and self-help groups will be done twice throughout the project period. The control arm will not receive any form of intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | Mental health status (especially, depression and generalized anxiety disorder) and the quality of life measured using PHQ-9, GAD-7 and WHOQOL-BREF at baseline (before intervention) and repeated after 2 years of intervention |
| Secondary outcome measures | 1. Mental well-being of patients measured using the Warwick Edinburgh Mental Well-being Scale (WEMWBS) at baseline (before intervention) and repeated after 2 years of intervention 2. Self-stigma of leprosy patients measured with SARI Stigma Scale at baseline (before intervention) and repeated after 2 years of intervention 3. Social inclusion of leprosy patients by community members measured using the Social Distance Scale (SDS) at baseline (before intervention) and repeated after 2 years of intervention |
| Overall study start date | 01/07/2020 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 600 participants across 10 clusters (5 intervention, 5 control) with an average of 60 participants per cluster |
| Total final enrolment | 280 |
| Key inclusion criteria | 1. Any person affected by leprosy or Buruli ulcer 2. All people affected by leprosy or Buruli ulcer registered for treatment from 2014 up to 1 year before the end of the intervention 3. Participants aged between 15 to 65 years registered for treatment |
| Key exclusion criteria | 1. Refusal to give consent 2. Pregnant women 3. Patients who need urgent medical attention 4. Patients unable to communicate clearly |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 01/06/2022 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
Independence Layout
Enugu
400241
Nigeria
Sponsor information
Charity
56 Nza Street, Independence Layout
Enugu
400241
Nigeria
| Phone | +234 (0)8035076274 |
|---|---|
| ngozi.ekeke@dahw.org | |
| Website | https://www.dahw.de/ |
"ROR" |
https://ror.org/04jntfm70 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The findings will be published in a high-impact, peer-reviewed journal. The dissemination of findings will primarily target policymakers at National, State and LGA levels. The aim is to get the important lessons and conclusions into policy and practice and inform programming for the National Tuberculosis and Leprosy Control programme of the Federal Ministry of Health, Abuja Nigeria. Key findings will also be presented at national and international meetings/conferences. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are/will be available upon request from GLRA Secretariat (glra.nigeria@dahw.org). The primary data of patients will be available after the study completion on 30/06/2024 and will be available for about 5 years. Only the soft copy will be provided upon request for research purposes only. These will be released following data anonymization in accordance with best practices. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 18/03/2021 | No | Yes | ||
| Protocol file | 18/03/2021 | No | No | ||
| Protocol article | 14/06/2022 | 04/07/2022 | Yes | No |
Additional files
- ISRCTN83649248_PROTOCOL.pdf
- Uploaded 18/03/2021
- ISRCTN83649248_PIS.pdf
- Uploaded 18/03/2021
Editorial Notes
04/07/2022: Publication reference added.
08/06/2022: The total final enrolment was added.
18/03/2021: Uploaded protocol (not peer reviewed). The participant information sheet has been uploaded.
04/03/2021: Trial's existence confirmed by the Health Research and Ethics Committee, University of Nigeria Teaching Hospital.
