ClinicalTrials.gg
Not yet recruitingNCT07248462IMAGINEUpdated Nov 25, 2025

Integrating Mental Health Into Neglected Tropical Disease Care in Ghana

An interventional study of WHO Essential Care package for mental health and NTDs in Leprosy, Lymphatic Filariases and Buruli Ulcer, sponsored by Liverpool School of Tropical Medicine. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Liverpool School of Tropical Medicine · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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. 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)?'

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.

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Conditions studied

  • Leprosy
  • Lymphatic Filariases
  • Buruli Ulcer
  • Onchocerciasis
  • Yaws
03

In context

Leprosy

52 studies on the registry are indexed under Leprosy; 13 are open to participants now.

This study's planned enrollment of 200 is above the median of 70 across 41 interventional studies indexed under Leprosy.

Browse Leprosy studies →

Lead sponsor

Liverpool School of Tropical Medicine is the lead sponsor of 57 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Persons affected by NTDs

    Persons affected by NTDs in 4 areas in Ghana (Ho, Hohoe, Bole and Ellembele)

    Other: WHO Essential Care package for mental health and NTDs

Interventions

  • OtherWHO Essential Care package for mental health and NTDs

    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.

06

What researchers measure

Primary outcomes

  1. Depression

    Depression as measured by PHQ-9

    Time frame: From enrolment to the end of the intervention period 12 months later

  2. anxiety

    Anxiety as measured by GAD-7

    Time frame: From enrolment until end of intervention period 12 months later

  3. Mental wellbeing

    Mental wellbeing as measured by Warwick mental wellbeing scale

    Time frame: From enrolment until end of intervention period 12 months later

Secondary outcomes

  1. Quality of Life

    QoL as measured by EQ-5D-5L

    Time frame: From enrolment until end of intervention period 12 months later

  2. Participation

    Social participation as measured by Participation Scale

    Time frame: From enrolment until end of intervention 12 months later

  3. Stigma

    Stigma as measured by sari stigma scale

    Time frame: Enrolment - end of intervention period 12 months later

07

Study locations

No study locations are listed for this record.

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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07248462
Lead sponsor
Liverpool School of Tropical Medicine
Collaborators
University of Health and Allied Sciences, Fundación Anesvad, Effect:Hope
Responsible party
Sponsor
First posted
Nov 25, 2025
Start date
Nov 2025 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Nov 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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