Conducting a RCT during wartime in Ukraine: methodological implications and lessons learnt
V Kachai, D Fuhr, S BogdanovAbstract
Background
The onset of conflict in 2014, followed by Russia’s full-scale invasion of Ukraine in 2022, has exacerbated mental health problems, particularly alcohol misuse and psychological distress. The CHANGE trial aimed to evaluate the effectiveness of a transdiagnostic intervention targeting these issues in the context of an ongoing war. Various methodological challenges were encountered during the conduct of the study, requiring strategies for recruitment and retention.
Methods
CHANGE is a parallel-arm, single-blind, individually randomised controlled trial conducted remotely, aiming to enrol 500 war-affected men from Ukrainian government-controlled territories. Participants are randomised 1:1 to enhanced usual care (EUC) and CHANGE intervention, or EUC alone. The primary outcome is the percentage of days abstinent from alcohol. A mixed-methods process evaluation measures different indicators, including recruitment and retention.
Results
It took almost 15 months to recruit half of the target sample. Participants were often hesitant to take part due to data safety concerns, mistrust, stigma, or competing demands. To address these challenges, a range of strategies was implemented to enhance recruitment, including social media dissemination, cooperation with an agency holding a network of recruiters, and reimbursement for treatment sessions participation. Retention issues occurred due to conscription and income-related priorities and were addressed through repeated follow-ups and compensation.
Conclusions
The CHANGE trial demonstrates that flexibility and adaptability are essential for research in wartime. Recruitment demands constant negotiation, proactivity, and resources, while retention strategies must account for shifting priorities and conscription. The main implication for further research practice and interventions implementation is the need to invest in participants engagement, especially for sensitive and stigmatized topics in conflict-affected settings.