LeprosyIMAGINENCT07248462
Integrating Mental Health Into Neglected Tropical Disease Care in Ghana
A study testing WHO Essential Care package for mental health and NTDs in people with Leprosy and Lymphatic Filariases, run by Liverpool School of Tropical Medicine.
Trial summary
Background Neglected Tropical Diseases (NTDs) are a group of diseases that are more common among the poorest people in the poorest countries. People affected by these conditions often experience pain, changes in their physical appearance, stigma and discrimination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leprosy, Lymphatic Filariases, Buruli Ulcer
- What is being tested?
- WHO Essential Care package for mental health and NTDs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Affected by one of the target NTDs (leprosy, LF, buruli Ulcer, Yaws, Onchocersiasis)
- Living in one of the intervention areas (Bole, Ho, Hohoe, Ellembele)
- Aged 18 years and above
Who cannot join
- -
About this study
Official title: Integrating Mental Health and Neglected Tropical Disease Interventions to Support Equitable People-Centred Care in Ghana
Background Neglected Tropical Diseases (NTDs) are a group of diseases that are more common among the poorest people in the poorest countries. People affected by these conditions often experience pain, changes in their physical appearance, stigma and discrimination. As a result, they are more likely to experience mental distress including depression and anxiety. It is important that people affected by these conditions are found early, so that they can start treatment to stop the progression of the condition and to support their mental wellbeing. The World Health Organisation recently developed guidance that explains more about including mental health awareness and care as part of the management of people who have these conditions. This is called the Essential Care Package for NTDs, Stigma and Mental Health Conditions. However, so far there has been limited research about 'what works' when providing this package to people who need it.
Aim of the study Through this study, we aim to understand 'How can the health system in Ghana provide the essential care package for people affected by skin NTDs for large groups of the population (at scale)?; and how to do this in a way that means everyone can access it (that is fair) and that is effective (works well)?'
Read more
Methods/ Design In order to do this, we will develop a Ghanaian version of the Essential Care Package and associated resources to support its implementation. We will do this by including people affected by NTDs to help us understand the needs and priorities from their perspective. Working together with researchers, health workers and those who make decisions about health, people affected will be supported to identify their priorities and to take part in developing what will be included in this Ghanaian ECP. This will happen by using creative forms of research that encourage people to participate and through the process, with workshops to include their opinions scheduled throughout.
Once this has been developed the Government will then start to introduce the Ghanaian ECP in selected study districts. At the same time, we will monitor and evaluate what is happening to understand what parts work well? who they work best for? in what settings? and for how long? We will carry out different types of research to understand who has access to this new package of services? (how fair is it?), how well it works? How the health workers and health system take up and use the new ECP? How the new ECP is rolled out and introduced as part of the health system? And whether it can be maintained and continue beyond the end of the study?
Discussion Through this study, we hope that people affected by NTDs and mental health conditions will be able to access and use quality health services when they need them; that communities will have a better understanding about NTDs and mental health conditions; and that government departments will work better together to provide care for NTDs and mental health conditions together.
- Conditions
- Leprosy, Lymphatic Filariases, Buruli Ulcer, Onchocerciasis, Yaws
- Being tested
- WHO Essential Care package for mental health and NTDs
- Medical subject headings
- Leprosy, Elephantiasis, Filarial, Buruli Ulcer, Onchocerciasis, Yaws
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO Essential Care package for mental health and NTDsOther
Participants will receive integrated mental health and NTD care, following the WHO essential care package, using a stepped-care model with interventions at different levels of the health system. There will be population and community-level initiatives (e.g. peer support groups, awareness raising), decentralised management of patients including health worker capcity strenghtening (e.g. mhGAP, screening as part of routine care), and referral into secondary or tertiary care.
| Study group | Role | What they receive |
|---|---|---|
| Persons affected by NTDs | Experimental | Persons affected by NTDs in 4 areas in Ghana (Ho, Hohoe, Bole and Ellembele) Receives: Other: WHO Essential Care package for mental health and NTDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Depression as measured by PHQ-9
Measured: From enrolment to the end of the intervention period 12 months later
anxiety
Anxiety as measured by GAD-7
Measured: From enrolment until end of intervention period 12 months later
Mental wellbeing
Mental wellbeing as measured by Warwick mental wellbeing scale
Measured: From enrolment until end of intervention period 12 months later
Secondary outcomes (3)
Quality of Life
QoL as measured by EQ-5D-5L
Measured: From enrolment until end of intervention period 12 months later
Participation
Social participation as measured by Participation Scale
Measured: From enrolment until end of intervention 12 months later
Stigma
Stigma as measured by sari stigma scale
Measured: Enrolment - end of intervention period 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Health and Allied Sciences, Fundación Anesvad, Effect:Hope
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248462
- Sponsor's protocol ID
- 25-026
- Acronym
- IMAGINE
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No