Abstract
<title>Abstract</title> <p>Background There is a lack of scalable, community-based interventions addressing alcohol misuse in conflict-affected humanitarian settings. To address this gap, we developed CHANGE, a psychological intervention targeting alcohol misuse and psychological distress among war-affected men in Ukraine. This individually randomised feasibility trial aimed to assess study procedures in preparation for a definitive randomised controlled trial, evaluate implementation outcomes including feasibility and acceptability, and explore preliminary perceptions of the intervention’s effectiveness. Methods A parallel-arm, single-blind, individually randomised feasibility trial was conducted in Kyiv and Dnipro. Adult men affected by war (≥ 18 years) were randomised (1:1) to either the CHANGE intervention plus enhanced usual care (EUC) or EUC alone. Interventions and assessments were delivered either in person or remotely. Outcomes were assessed at baseline and 3 months post-randomisation. A mixed-methods approach was used to evaluate feasibility indicators (recruitment, retention, randomisation, and data collection), acceptability, feasibility of delivery, safety, and perceived effectiveness. Results Of 122 individuals screened, 62 were enrolled over 7 months. Most exclusions (77%) were due to high Alcohol Use Disorders Identification Test scores. Retention at 3 months was 66%. Fourteen participants who discontinued the intervention were not invited to follow-up due to a procedural oversight. Participants and facilitators considered the intervention acceptable and relevant to the war context, with remote delivery enhancing feasibility. No adverse events were reported. Participants and implementation teams perceived the intervention as helpful in reducing alcohol misuse. Recruitment was challenged by low motivation, stigma, and war-related logistical barriers. Conclusions The CHANGE intervention and trial procedures were feasible and acceptable, particularly when delivered remotely. Modifications for the definitive trial include expanding recruitment to all government-controlled regions, excluding occupied territories for safety reasons, and refining eligibility criteria (e.g., excluding prior substance use treatment). These findings support progression to a fully powered RCT evaluating an intervention addressing psychological distress and alcohol misuse among war-affected men. Trial registration ISRCTN11369479</p>