Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: study protocol

IntroductionA digital programme, MoodHwb, was co-designed with young people experiencing or at high risk of depression, parents/carers, and professionals, to provide support for young people with their mood and wellbeing. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. The present study aims to refine the programme based on user feedback, and to assess the acceptability and feasibility of the updated version and study methods. Methods and analysisInitially, this study will refine MoodHwb with the involvement of young people, including in a pre-trial acceptability phase. This will be followed by a multi-centre feasibility randomised controlled trial comparing MoodHwb plus usual care with a digital information pack plus usual care. Up to 120 young people aged 13-19 years with symptoms of depression and their parents/carers will be recruited through schools, primary mental health services, youth services, charities, and voluntary self-referral in Wales and Scotland. The primary outcomes are the feasibility and acceptability of the MoodHwb programme (including usage, design, and content) and of trial methods (including recruitment and retention rates), assessed two months post-randomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, wellbeing and depression and anxiety symptoms measured at two months post-randomisation. Ethics and disseminationThe pre-trial acceptability phase was approved by the Cardiff University School of Medicine Research Ethics Committee (REC) and the University of Glasgow College of Medicine, Veterinary and Life Sciences REC. The trial was approved by Wales NHS REC 3 (21/WA/0205), the Health Research Authority (HRA), Health and Care Research Wales (HCRW), university health board R&D departments in Wales, and schools in Wales and Scotland. Findings will be disseminated in peer-reviewed open-access journals, at conferences and meetings, and online to academic, clinical, and educational audiences and the wider public. Trial registration numberISRCTN12437531. Strengths and limitations of this studyO_LIMoodHwb was co-designed with young people with lived experience or at high risk of depression, parents/carers, and practitioners. C_LIO_LIMoodHwb is bilingual, personalised according to user needs and preferences, and has been developed in line with evidence-based approaches to support young people with depressive symptoms and their parents/carers, friends, and practitioners. C_LIO_LIMultiple methods will be used to collect data in a range of settings for the trial, including validated questionnaires, semi-structured interviews, a focus group, and Web/app usage monitoring. C_LIO_LIAs this is a feasibility study, we will not be able to determine the effectiveness of MoodHwb; however, the findings will inform the design of a definitive effectiveness trial. C_LIO_LIParticipants will not be blind to treatment allocation as this is not possible with an intervention of this kind. C_LI