Journal Article

Effectiveness and cost-effectiveness of a transdiagnostic intervention targeting alcohol misuse and psychological distress for men in Ukraine: study protocol for a randomised controlled trial

Neuman, Melissa, May, Carl, Nadkarni, Abhijit, van der Boor, Catharina F., Fuhr, Daniela C., Roberts, Bayard, Pastukhova, Alona, Harbar, Kateryna, Weiss, Helen A., Greco, Giulia, Bogdanov, Sergiy, Kachai, Vita

2025

Overview

Background Ukraine has experienced armed conflict since 2014, with significant escalation in 2022. Since then, an estimated 3.7 million people have been internally displaced. Alcohol misuse remains a substantial public health challenge in Ukraine, with high levels of psychological distress among the displaced population. The current study aims to evaluate the effectiveness and cost-effectiveness of a transdiagnostic intervention (CHANGE) to address alcohol misuse and psychological distress through problem-solving therapy and selected behavioural strategies for managing alcohol misuse. We hypothesize that CHANGE, together with enhanced usual care (EUC), will be more effective in increasing the percentage of days abstinent (PDA) than EUC alone. Methods This study is a parallel-arm, single-blind, individually randomised controlled trial across Ukraine government-controlled territories. Following informed consent, we will recruit 500 adult war-affected men, randomised 1:1 to EUC and CHANGE, or EUC alone. Inclusion criteria include elevated levels of alcohol use (between 8 and 19, inclusive, on the Alcohol Use Disorder Identification Test); psychological distress (≥ 16 on the Kessler Psychological Distress Scale) and ability to speak Ukrainian or Russian. CHANGE will be delivered over 6 weeks by 14 community-based facilitators, with outcomes assessed at 3 months post-randomisation. The primary outcome for CHANGE is the PDA from alcohol at 3 months, measured using the Timeline Follow Back. Secondary outcomes include percentage days of heavy drinking, alcohol misuse, psychological distress (depression, anxiety, and posttraumatic stress disorder), functional disability, intimate partner violence perpetration and health economics indicators at 3 months. The primary analysis will follow an intention-to-treat approach. A mixed-methods process evaluation will examine facilitator competency, recruitment, retention/completion, appropriateness, dose received, fidelity and feasibility of delivery and acceptability. Discussion CHANGE is the first intervention aiming to address alcohol misuse and psychological distress in an active conflict setting. Trial registration ISRCTN14881856. Registered on 5th of July 2024.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adaptation / Adult / Alcohol / Alcohol Abstinence / Alcohol abuse / Alcohol use / Alcoholism / Alcoholism - diagnosis / Alcoholism - economics / Alcoholism - psychology / Alcoholism - therapy / Analysis / Anxiety / Armed Conflicts - psychology / Biomedicine / Clinical trials / Conflict / Cost analysis / Cost control / Cost-Benefit Analysis / Depression, Mental / Displaced persons / Drinking of alcoholic beverages / Economic aspects / Epidemiology / Family violence / Global health / Health Sciences / Health services / Humans / Hygiene / Intervention / Male / Medical economics / Medicine / Medicine & Public Health / Mental depression / Mental disorders / Mental distress / Mental health care / Post traumatic stress disorder / Psychological Distress / Public health / Randomised controlled trial / Randomized Controlled Trials as Topic / Scalable interventions / Single-Blind Method / Statistics for Life Sciences / Stress (Psychology) / Stress, Psychological - economics / Stress, Psychological - psychology / Stress, Psychological - therapy / Study Protocol / Treatment Outcome / Ukraine / Young Adult