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

INTRODUCTION: A digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. This 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 ANALYSIS: Initially, this study will refine MoodHwb with the involvement of young people, including in a pretrial acceptability phase. This will be followed by a multicentre 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, 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 2 months postrandomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, well-being and depression and anxiety symptoms measured at 2 months postrandomisation. ETHICS AND DISSEMINATION: The pretrial 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 Research and Development (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 NUMBER: ISRCTN12437531.

Web-based physical activity intervention for people with progressive multiple sclerosis: application of consensus-based intervention development guidance.

OBJECTIVES: People with progressive multiple sclerosis (PwPMS) report that they recognise the benefits of activity on their physical and psychological health but need support to achieve their physical activity goals. We aimed to systematically develop a theoretically informed intervention that would enable PwPMS to more readily engage in regular physical activity. DESIGN: We used an intervention mapping approach to inform intervention development. SETTING: We conducted semistructured interviews with PwPMS and their families/carers and physiotherapists recruited from secondary care settings. PARTICIPANTS: Fourteen PwPMS with an Expanded Disability Status Scale score of between 6 and 8 and 7 of their families/carers and 13 physiotherapists and 1 physiotherapy technician participated. RESULTS: Interview data suggested that the development of supportive coaching relationships with physiotherapists could promote the ability of PwPMS to achieve a desirable and achievable physical activity plan. These interview data informed the prototype 'Lifestyle Exercise and Activity Package for Multiple Sclerosis' (LEAP-MS) consisting of a secure multiuser web-based platform (with an education and activity suite, interactive components enabling selection of exercises, goal setting and activity logging), up to six flexible face-to-face or web-based physiotherapy coaching sessions and remote support via an embedded web-based messaging function that all together draw on specific theory-based methods to achieve physical activity behaviour change, namely active learning, reinforcement, modelling, feedback, facilitation, goal setting and guided practice. Implementation is within a multiuser platform accessible to participants, trained physiotherapists and researchers. CONCLUSIONS: We have followed an inclusive, systematic and transparent process to develop the LEAP-MS intervention that enables detailed description of components, context and guiding principles to inform ongoing evaluation. Importantly, PwPMS expressed the need for autonomy in developing physical activity plans. This has been achieved through the embedding of self-management principles in the design and delivery of the LEAP-MS intervention.