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Alcohol is causally related to more than 200 diseases and injuries. Alcohol health warning labels are a promising intervention to address alcohol-related harm with multiple possible roles, but research on its real-world impacts is lacking. This study aims to experimentally evaluate the impact of exposure to two types of content (responsibility and cancer message) and positioning of the message (front or back) on knowledge of alcohol causing cancer as the primary outcome and alcohol consumption behaviour, intentions, risk perception, emotional response, product appeal and policy support as secondary outcomes. The study also aims to assess the potential testing effect of pre-measurement on the primary outcome.
Participants (of the legal drinking age in Spain (18 years or older), purchased at least one alcoholic beverage (with alcohol by volume (ABV) ≥ 1.2% for their own consumption and speaking Catalan or Spanish) will be recruited outside of supermarkets in Barcelona after purchasing alcohol, randomly assigned into one of the eight experimental groups, complete a baseline questionnaire (with half of the sample answering baseline questions measuring knowledge) and receive label stickers displaying either responsibility or cancer message, and applied to either front or back of every alcohol container they have purchased. They will complete follow-up surveys measuring the primary and secondary outcomes 1 week and 1 month after the intervention, either online or via telephone. The key hypotheses are that the label containing a cancer message will have a greater impact on the primary and secondary outcomes compared with the responsibility label. To evaluate the impact of health warning labels on knowledge of alcohol causing cancer, logistic regression will be employed to model the probability of a correct response as a function of the key independent variables, with results reported as ORs. Secondary outcomes will be modelled through linear regressions for continuous variables, and through logistic regressions for dichotomic variables or categorical variables that will be dichotomised a priori. The target sample size is 1300 participants.
The study has been approved by the Ethical Committee for Research with Medicines (CEIm) IDIAP Jordi Gol (24/228-P) and the Ethical Research Committee of the WHO (ERC.0004213). The results will be disseminated in peer-reviewed journals, on social media and policy fora in national, European and global context, and will inform WHO and European Union-level policy recommendations.
European Commission, Directorate General for Health and Food Safety, SANTE/2022/SI2.883729.
Many people with psychosis find the world very frightening. It can be difficult for them to do everyday things—for example, walking down a busy street, travelling on a bus or going to the shops. Sometimes, the fears are so great that individuals rarely leave their homes. gameChange virtual reality therapy is designed to reduce this agoraphobic avoidance. In gameChange, users practise going into computerised immersive versions of ordinary situations. A virtual therapist guides users through the programme. A mental health worker also supports people. People normally do six sessions of gameChange, but now they can do more as headsets can be left with many people. We originally tested gameChange with 346 patients with psychosis. People saw a significant reduction in their fears. People with the most severe problems made the biggest improvements. This led to gameChange receiving National Institute for Health and Care Excellence (NICE) Early Value Assessment (EVA) approval for its use with patients with psychosis who have severe agoraphobic avoidance. NICE EVA approval is conditional on further evidence generation. We aim to carry out a real-world trial of gameChange used in the NHS. The overall aim is to gather evidence on the four essential areas (clinical benefits on agoraphobia, level of engagement and adherence, healthcare resource use, adverse effects) and the two further supporting areas (health-related quality of life, generalisability) identified in the NICE evidence generation plan for gameChange.
200 patients with psychosis and severe agoraphobic avoidance will be randomised (1:1) to receive gameChange in addition to treatment as usual (TAU) or to a waitlist control group receiving TAU. Assessments will be conducted blind to group allocation at baseline, 8 weeks (end of treatment) and 26 weeks (follow-up). The trial will be embedded in services in at least seven National Health Service (NHS) trusts across England. The primary outcome is agoraphobic avoidance at 26 weeks assessed with the Oxford Agoraphobic Avoidance Scale. The secondary clinical outcomes are agoraphobic distress, paranoia and social contacts. There will be tests of moderation of the main clinical outcome. Treatment acceptability, adverse effects and cost-effectiveness will also be assessed. The target estimand is the treatment policy estimand and all primary and secondary analyses will be carried out incorporating data from all participants including those who do not complete treatment.
The trial has received ethical approval from the NHS Health Research Authority and Health and Care Research Wales (25/WA/0081). A key output will be the evidence needed for a NICE guidance update on gameChange and a clear recommendation concerning future routine use in the NHS.
FreshRSS 