CHANGE is a five-year research project which started in July 2020 and is funded by the Wellcome Trust and the Department of Health and Social Care, through the National Institute for Health Research using the UK’s Official Development Assistance Funding. CHANGE seeks to develop a transdiagnostic intervention addressing mental health comorbidities (alcohol misuse, depression, anxiety and post-traumatic stress disorders) among conflict-affected populations in Uganda and Ukraine.
The aim of CHANGE is to address alcohol misuse and associated adversities among conflict-affected populations in Uganda and Ukraine. CHANGE seeks to further develop, an evidence-based psychological intervention designed for people with psychological distress who are exposed to adversity. We will complement by adding an additional psychological component addressing alcohol misuse.
CHANGE is a partnership between HealthRight International Uganda, the London School of Hygiene and Tropical Medicine, the National University of Kyiv-Mohyla, the University of Copenhagen, and WordsHelp Ukraine. CHANGE applies a participatory research approach with key stakeholders and conflict-affected populations involved in the development and implementation of the intervention.
We are witnessing the highest levels of forced displacement on record, with one person forcibly displaced every two seconds as a result of conflict, violence or persecution. Conflict-affected populations are vulnerable to psychosocial distress and are at risk of considerably higher levels of mental disorders than non-conflict-affected populations including alcohol misuse. Alcohol may be used as strategy to cope with adversities which refugees and internally displaced persons might face, and may cause or result from psychosocial distress. UNHCR have highlighted that alcohol misuse among forcibly-displaced populations is a neglected problem, and that psychological inteventions addressing mental health co-morbidities including alcohol miuse are lacking.
CHANGE is a five-year research project which started in July 2020 and is funded by the NIHR–Wellcome Partnership for Global Health Research. CHANGE is based on the Problem Management Plus (PM+) intervention, an evidence-based psychological intervention developed by the WHO designed for people with psychological distress who are exposed to adversity. The CHANGE project seeks to further develop PM+ by adding an additional psychological component addressing alcohol misuse.
The overall aim of CHANGE is to address alcohol misuse and associated adversities among conflict-affected populations in Uganda and Ukraine.
The specific objectives of CHANGE are to:
- To identify strategies and techniques from evidence-based alcohol use therapies and combine them with strategies from PM+, to develop a new intervention that can address psychological distress and alcohol misuse.
- To adapt this new CHANGE intervention to local circumstances, and to examine the feasibility, acceptability, perceived effectiveness and preliminary impact thereof.
- To evaluate effectiveness and cost-effectiveness of the CHANGE intervention through two randomised controlled trials in Uganda and Ukraine
- To explore the process of implementation, and to identify, characterise and explain mechanisms that promote or inhibit the delivery and take-up of the CHANGE intervention in both settings
- To examine the potential for scaling-up the CHANGE intervention in Uganda and Ukraine
CHANGE applies a participatory research approach with key stakeholders and conflict-affected populations involved in the development and implementation of the intervention.
Study settings and location
The CHANGE intervention will be implemented among refugees from South Sudan living in the Rhino refugee settlement in Uganda; and internally displaced persons and other conflict-affected men (e.g. military veterans) in the region of Dnipro in Ukraine. These study locations have been selected because they have high levels of alcohol misuse, mental disorders, gender-based violence, and a high mental health treatment gap. These country settings represent very different socio-economic, cultural and humanitarian characteristics and populations which supports understanding of the contextual influences on adapting and implementing the CHANGE intervention. The comparison of outcomes and processes between the two sites will also help inform the future development and application of the CHANGE intervention with other conflict-affected populations.
Acknowledgements
This work was supported by the National Institute for Health Research (NIHR) (using the UK’s Official Development Assistance (ODA) Funding) and Wellcome (grant reference number 219468/Z/19/Z) under the NIHR-Wellcome Partnership for Global Health Research. The views expressed are those of the authors and not necessarily those of Wellcome, the NIHR or the Department of Health and Social Care.
CHANGE consists of six Work Packages (described below).
- Work Package One: Intervention development
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The objective of Work Package One is to identify strategies and techniques from evidence-based alcohol use disorder therapies which can be integrated into PM+ strategies, and to develop the CHANGE intervention treatment manual. The research methods include literature reviews, Theory of Change workshops, community-based participatory research with conflict-affected populations in Uganda and Ukraine, and a treatment development workshop with experts in addiction and mental health.
Lead: Abhijit Nadkarni; country leads Sergiy Bogdanov (Ukraine), Wietse Tol (Uganda)
- Work Package Two: Adaptation of the CHANGE intervention, including pilot RCTs
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The objective of Work Package Two is to adapt the CHANGE intervention to local circumstances, and to examine the feasibility, acceptability, perceived effectiveness and preliminary impact thereof.
More specifically, Work Package Two seeks to conduct a before/after treatment cohort to obtain guidance from refugees (Uganda) and internally displaced persons (Ukraine) on additional adaptations needed to enhance the relevance, appropriateness and acceptability of the CHANGE intervention; and to conduct two pilot RCTs in Ukraine and Uganda to fine-tune methodological procedures of the intervention.
Lead: Daniela Fuhr; country leads Sergiy Bogdanov (Ukraine), Wietse Tol (Uganda)
- Work Package Three: Effectiveness Evaluation
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The objectives of Work Package Three is to evaluate the effectiveness of the CHANGE intervention through two randomised controlled trials in Uganda and Ukraine. We plan to run a parallel arm single-blind individual randomised controlled trial in Uganda and Ukraine with 500 men in each country/site randomised 1:1 to the intervention and enhanced usual care or enhanced usual care alone. Outcomes will be measured at 3- and 12-months post-recruitment.
Lead: Helen Weiss; country leads Sergiy Bogdanov (Ukraine), Wietse Tol (Uganda)
- Work Package Four: Cost-Effectiveness Evaluation
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The objective of Work Package Four is to evaluate the cost-effectiveness of the CHANGE intervention. We will test whether the intervention and enhanced usual care is cost-effective compared to enhanced usual care alone for populations of refugees and internally displaced persons in Uganda and Ukraine. We will assess the incremental cost per DALY averted and cost per QALY of the CHANGE intervention compared to enhanced usual care from a societal perspective over a life time horizon.
Lead: Anna Vassall; country leads Sergiy Bogdanov (Ukraine), Wietse Tol (Uganda)
- Work Package Five: In-depth investigation on implementation processes
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The objective of Work Package Five is explore the process of implementation of the CHANGE intervention across the life of the project, and to identify, characterise and explain mechanisms that promote or inhibit the delivery and take-up of the intervention. We will apply a theoretical model of implementation processes, normalisation process theory, to inform fieldwork aimed at understanding the dynamics of enacting the intervention. During the intervention development phase, we will collect qualitative data through semi-structured interviews and ethnographic observation of meetings and workshops. In the pilot RCT we will focus on understanding the ways in which the translational gap between the process of intervention design and the experience of everyday practice is understood and bridged. In the definitive trial, we will undertake qualitative semi-structured interviews with healthcare managers, clinicians, and lay healthcare workers. Interviews will be aimed at eliciting their interpretations of these data and their explanations of the processes that have led to these results.
Lead: Carl May; country leads Sergiy Bogdanov (Ukraine), Wietse Tol (Uganda)
- Work Package Six: Scaling up
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The objective of Work Package Six is to examine the potential for scaling-up the CHANGE intervention in Uganda and Ukraine. To help make the intervention widely available, we will investigate how it could be scaled-up through the health system (both government and humanitarian) and also integrated within other humanitarian sector activities such as protection programmes for survivors of gender-based violence. The methods will consist of document and policy reviews, Theory of Change workshops, and key informant interviews.
Lead: Bayard Roberts; country leads Sergiy Bogdanov (Ukraine), Wietse Tol (Uganda)
CHANGE is a partnership between HealthRight International Uganda, the London School of Hygiene and Tropical Medicine, the National University of Kyiv-Mohyla, the University of Copenhagen, and WordsHelp Ukraine.
CHANGE Partners
National University of Kyiv-Mohyla
Daniela Fuhr
Overall Principal Investigator
Bayard
Roberts
Professor of Health Systems & Policy
Wietse Tol
Uganda Principal Investigator / University of Copenhagen / HealthRight International,
Sergiy Bogdanov
Associated Professor / Ukraine Principal Investigator / National university of Kyiv-Mohyla
Eugene Kinyanda
Uganda co-PI / MRC / UVRI / LSHTM Uganda Research Unit
Helen
Weiss
Professor of Epidemiology
Abhijit
Nadkarni
Assoc. Professor - Global Mental Health
Carl
May
Prof in Health Systems Implementation
Giulia
Greco
Associate Professor
Volodymyr Kharytonenko
Head of the NGO ‘Words Help’
Daniel
Mongiardi
Project Manager - RECAP
Catharina
Van der Boor
Assistant Professor
Dalili Taban
Project Coordinator Uganda
Vita Kachay
Study Director
Kateryna Harbar
Research Assistant / Qualitative Research Specialist
Oksana Bayer
Researcher / National University of Kyiv-Mohyla Academy
Andriy Karachevskyi
Researcher / National University of Kyiv-Mohyla Academy
Trial Steering Committee
- Marit Sijbrandij, VU University Amsterdam (Independent chair)
- Sergiy Bogdanov, National University of Kyiv-Mohyla
- Daniela Fuhr, London School of Hygiene and Tropical Medicine
- Irina Ivanchuk, Ministry of Health Ukraine
- Jeremy Kane, Columbia University
- Eugene Kinyanda, MRC Uganda
- Phiona Koyiet, World Vision
- Hafsa Lukwata, Ministry of Health Uganda
- Nino Makhashvili, Ilia State University
- Olena Nesterova, Ministry of Health Ukraine
- Elena Netsi, Wellcome Trust
- Raymond Odokonyero, Psychiatrist Uganda
- Bayard Roberts, London School of Hygiene and Tropical Medicine
- Wietse Tol, University of Copenhagen and HealthRight International
- Peter Ventevogel, UNHCR
- Helen Weiss, London School of Hygiene and Tropical Medicine
Uganda
Until today, we have trained 17 facilitators and successfully completed the pilot RCT.
The formative research phase further informed the development of the CHANGE intervention which included the integration of more locally relevant examples and more flexible therapy techniques to better resonate with the participants.
Recruitment for the definite RCT began in August 2023. The recruitment of 504 individuals was completed within four months, and the 3-month follow-up, including qualitative interviews, was completed in March 2024. The 12-month follow-up is due to start in August 2024.
Ukraine
Before the pilot RCT, we conducted an additional qualitative study to investigate MHPSS needs, resilience and help-seeking behaviours of conflict-affected civilians in Ukraine. 8 lay healthcare workers and 4 data collectors were extensively trained to deliver the CHANGE intervention in 2023. Recruitment to the pilot RCT is currently being finalised, and qualitative interviews are being conducted to inform delivery of the CHANGE intervention. The full RCT is due to start in Ukraine in June 2024.
Over the last few months, we have been deeply affected and concerned by the war in Ukraine. We have seen that the mental health and psychosocial support (MHPSS) needs amongst affected populations have increased hugely due to exposure to the conflict, threat of violence, and forced displacement. The war has meant that we have had to make important decisions for the CHANGE project, adjusting our initial programme of work to ensure the safety and wellbeing of our partners in Ukraine. We are instead in the process of conducting a qualitative study that seeks to investigate MHPSS needs and resilience of conflict-affected civilians in Ukraine. This qualitative study will inform MHPSS programming and will provide a contextual update for CHANGE and other MHPSS projects that are being implemented in Ukraine.
Simultaneously, we are progressing well with CHANGE in Uganda. Over the last couple of months, we have recruited new team members in Arua, including PM+A supervisors, PM+ facilitators and research assistants. We have successfully finalised training of the intervention master trainers, and facilitators who have completed their first practice cases. We are now actively recruiting participants for a treatment cohort.
Please stay tuned for more progress updates.
We were busy driving forward the development of our intervention in the past few months, and conducted a series of research activities to inform content of the intervention:
- Meta-review of common elements of treatments for alcohol use disorders (AUD): We conducted an umbrella review of all meta-analyses of psychological therapies for AUD to identify what common elements characterize psychological therapies for AUD. We identified 30 different common elements of AUD treatments which included psychoeducation, change & action planning, cognitive restructuring, and motivational interviewing.
- Community qualitative interviews: We collected N=126 in-depth interviews in both sites (N=57 in Uganda and N=69 in Ukraine) on the perceived need, explanatory models and current treatment options for AUD. Data was collected from men with alcohol misuse problems, family members of men, community & religious leaders, and MHPSS providers.
- Delphi study: A 2-round Delphi survey was conducted with international experts to gauge relevance of different active ingredients/intervention components for AUD that were identified in the systematic review. We had 25 experts from all over the world completing the first round of the Delphi survey and 23 experts completing the second round to reach consensus.
- Treatment development workshop: We conducted three treatment development workshops with 25 international experts to build the intervention architecture (two treatment development workshops conducted in English, and one treatment development workshop conducted in Ukrainian).
- Theory of change (ToC) workshops: ToC workshops were held in both Uganda and Ukraine to develop a causal map outlying how the intervention may influence the desired outcome in the contexts where the intervention will be implemented. Three ToC workshops took place in Uganda (one in the Rhino refugee camp, one in Arua, and one in Kampala) and two ToC workshops took place online in Ukraine.
We have also published two open access papers:
- A commentary published in the Intervention Journal of Mental Health and Psychosocial Support in Conflict Affected Areas introducing the CHANGE project
- A protocol paper detailing all the qualitative components that will be included in the CHANGE project published in the International Journal of Qualitative Methods
We look forward to getting started with our next steps: a treatment cohort of the CHANGE intervention to refine it and a pilot randomized controlled trial.
Stay tuned for more updates on our progress!
Our project has been featured on the London School of Hygiene and Tropical Medicine's newsfeed. The text from the article can be found below, read the original post.
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Every two seconds someone in the world is forcibly displaced as a result of conflict, violence or persecution. These populations affected by conflict are particularly vulnerable to psychosocial distress and much higher levels of mental disorders, including alcohol misuse, than populations who don’t experience conflict. In these settings, alcohol may be used as a coping strategy for adversities that refugees and internally displaced persons may face.
The CHANGE study is a five-year project, led by Dr Daniela Fuhr and Professor Bayard Roberts, titled ‘Alcohol use in Humanitarian settings: a programme of work to address alcohol and associated adversities among conflict-affected populations in Uganda and Ukraine’. Launched in July 2020, project partners include LSHTM, HealthRight International Uganda, the National University of Kyiv-Mohyla, WordsHelp Ukraine, and the University of Copenhagen.
CHANGE seeks to develop the first evidence-based psychological intervention with a component addressing alcohol misuse. Specifically, they seek to further develop Problem Management Plus (PM+), an intervention developed by the World Health Organization (WHO) designed for people with psychological distress who are exposed to adversity by identifying and integrating strategies and techniques from alcohol use therapies.
An expanded version of this intervention, Project Management Plus Alcohol (PM+A), can then be adapted to local circumstances, and its feasibility, acceptability, cost-effectiveness and scalability can be assessed through two randomised control trials in Uganda and Ukraine. In-depth qualitative research will be conducted throughout the project to better understand the implementation of the intervention, and how local contextual mechanisms influence outcomes.
The United Nations Higher Commission for Refugees (UNHCR) have highlighted alcohol misuse as a neglected problem among forcibly displaced populations, and that psychological interventions addressing mental health co-morbidities including alcohol misuse are lacking.
PM+A will be implemented among South Sudanese refugees living in the Rhino refugee settlement in Uganda and internally displaced persons in the Dnipro region of Ukraine. These regions have been found to have high levels of alcohol misuse, mental disorders, gender-based violence and a high mental health treatment gap.
These country settings represent varied different socio-economic, cultural and humanitarian characteristics and populations, which supports understanding of the contextual influences on adapting and implementing PM+A in differing circumstances.
Dr Fuhr, Assistant Professor in Mental Health Systems at LSHTM and project lead, said: “We are very pleased to have received this funding for the CHANGE project. Conflict-affected areas create environments where people are much more vulnerable, so psychosocial distress, mental disorders and alcohol misuse are more common in these populations.
“By introducing a component addressing alcohol misuse to the PM+ mental health intervention, we hope to address this neglected problem and associated adversities in these populations. We are keen to develop an intervention which can be integrated into existing mental health and psychosocial support programmes.
“Our partners bring in-depth expertise about the local population, and it is very exciting for us to be able to compare outcomes and processes between our two study sites which are so very different to each other. This will inform the future development, application and scalability of PM+A with other conflict-affected populations.”
We are currently in the process of recruiting research staff for our sites in Uganda and Ukraine. Watch out for updates on our team page!
We are delighted to announce that the CHANGE project has been awarded funding by the NIHR–Wellcome Partnership for Global Health Research.
Effectiveness and cost-effectiveness of a transdiagnostic intervention for alcohol misuse and psychological distress in humanitarian settings: study protocol for a randomised controlled trial in Uganda
van der Boor, C. F., Taban, D., Tol, W. A., Akellot, J., Neuman, M., Weiss, H. A., ... & Fuhr, D. C. (2024).Trials, 25(1), 148.
This paper outlines the study protocol for the randomized controlled trial in Uganda.
Measuring refugees’ capabilities: translation, adaptation, and valuation of the OxCAP-MH into Juba Arabic for use among South Sudanese male refugees in Uganda
van der Boor, C. F., Taban, D., Ismail, K., Simon, J., Roberts, B., Fuhr, D., ... & Greco, G. (2024). Journal of Patient-Reported Outcomes, 8(1), 40.
This paper describes the adaptation and validation of the OxCAP-MH, a measure of capability well-being, for South Sudanese male refugees in Uganda, translating it into Juba Arabic.
Using theory of change to plan for the implementation of a psychological intervention addressing alcohol use disorder and psychological distress in Uganda
van der Boor, C., Andersen, L. S., Massazza, A., Tol, W. A., Taban, D., Roberts, B., ... & Fuhr, D. (2024). . Cambridge Prisms: Global Mental Health, 11, e6.
This paper presents a Theory of Change framework for the planning and implementation of the CHANGE intervention. It discusses pathways that influence the implementation and maintenance of the intervention in humanitarian settings, identifies key barriers and facilitators, and reflects on the conduct of the research process through stakeholder interviews.
Common strategies in empirically supported psychological interventions for alcohol use disorders: A meta‐review
Nadkarni, A., Massazza, A., Guda, R., Fernandes, L. T., Garg, A., Jolly, M., ... & Fuhr, D. (2023). . Drug and alcohol review, 42(1), 94-104.
This paper presents a meta-review of psychological interventions for alcohol use disorders (AUDs) that informed content of the CHANGE intervention.
Process evaluations of mental health and psychosocial support interventions for populations affected by humanitarian crises
Massazza, A., May, C. R., Roberts, B., Tol, W. A., Bogdanov, S., Nadkarni, A., & Fuhr, D. C. (2022). . Social Science & Medicine, 303.
This qualitative paper examines limitations and strengths of how process evaluations are conceptualised and implemented within randomised controlled trials of mental health and psychosocial support interventions for populations affected by humanitarian crises.
Problem Management Plus and Alcohol (PM+ A): A new intervention to address alcohol misuse and psychological distress among conflict-affected populations
Fuhr, D. C., Bogdanov, S., Tol, W. A., Nadkarni, A., & Roberts, B. (2021). Intervention Journal of Mental Health and Psychosocial Support in Conflict Affected Areas, 19(1)
This commentary discusses need of the CHANGE intervention and introduces the programme of work.
A complex intervention for alcohol misuse among conflict-affected populations in uganda and ukraine: study protocol for the qualitative components in the CHANGE trial
Massazza, A., Fuhr, D. C., Bogdanov, S., Tol, W. A., Roberts, B., Nadkarni, A., ... & May, C. R. (2021). International Journal of Qualitative Methods, 20.
This protocol outlines the qualitative research framework for the CHANGE project to be carried out in Uganda and Ukraine. It details the specific qualitative inquiries, methodological approaches for data analysis, and the integration of these methods across various work-packages to enhance the project's value.