Wellbeing App for Functional Dyspepsia: A Pilot Study

CBT mobile app: This app intervention is a seven-module CBT program co-designed in collaboration with individuals living with FD and experienced clinicians. Based on CBT, the app covers psychoeducation, relaxation training, cognitive restructuring and behavioural experiments. Each module includes 30 minutes of content delivered through videos, interactive activities and quizzes, designed for self-paced learning. This content is complemented by an additional 30 minutes of self-directed homework activities to reinforce and engage with the learned content. The sequential unlocking of modules on a weekly basis is designed to ensure participants systematically engage with the CBT principles and gradually build their skills through the program. Participants are expected to complete one module per week for 7 weeks. Activities within each module can be done at any time during the week. To provide personalised support, address any questions and monitor adherence, a therapist will conduct brief phone calls with participants during weeks 4 and 6 of the intervention. The intervention has been developed as a cross-platform app, allowing it to function on both Android and IOS operating systems. A connection to the internet or data is required to stream the videos in the app. The app is free to download. The number of activities completed will be collected via the app to assess adherence to the intervention. The seven modules included in the CBT-FD app are as follows: Module 1: The gut-brain connection The first module acknowledges that individuals experiencing persistent FD symptoms may be frustrated and struggling with the unknown nature of the symptoms. The module introduces the gut-brain connection and its role in perpetuating FD symptoms. Participants will learn about symptom tracking and complete a symptom diary for the week. Module 2: Stress and the gut The second module dives into stress and its impact on digestive wellbeing, particularly FD symptoms. To support symptom management, this module introduces three brief relaxation techniques (deep breathing, progressive muscle relaxation and guided imagery). Participants will be asked to practice at least one of the techniques consistently throughout the week. Module 3: Automatic thoughts The third module introduces the gastrointestinal-focused cognitive behavioural model in the context of FD, with examples. The second half of this module focuses on automatic thoughts and how to identify unhelpful ones. Participants will keep a thought diary throughout the week. Module 4: Alternative thoughts The fourth module covers ways to challenge unhelpful automatic thoughts to generate more helpful alternative thoughts. Participants will keep a thought diary throughout the week with additional thought-challenging prompts. Module 5: Coping skills The fifth module introduces problem vs emotion-focused coping. The rest of the module focuses on the vicious cycle of behaviours and symptoms and how to start scheduling back pleasant activities into their routine. Participants will schedule at least three pleasant activities for the upcoming week. Module 6: Behavioural experiments The sixth module introduces the feedback fear cycle. The rest of the module teaches different behavioural experiments, including hypothesis testing and exposure exercises. Participants will complete one of each experiment throughout the week. Module 7: Bringing it home The final module provides a summary of the learnings and provides prompts to create a personalised action plan for the future. Participants will create an action plan for the future. Onboarding Participants allocated to the app condition will go through a comprehensive onboarding with a member of the research team. This process will involve participants setting up their accounts and going through the first exercise together. For those who have already done a BSGM test within the last 6 months and had no changes to symptom management, they will do their onboarding session online. Account creation When participants open the app for the first time, they will be presented with a splash screen with a welcome message and prompts for basic demographic information used for personalisation. Users will then be required to create a secure account, allowing data storage and secure login/logout. Videos Each module incorporates at least one embedded portrait video providing accessible visual and auditory explanations of the module’s content. An internet or data connection is required to stream the video content within the app. These videos can be accessed and revisited under the ‘modules’ tab. Activities Each module offers three or more interactive activities designed to actively engage users with the content covered in the videos. For example, a matching game with cognitive distortions and thoughts or a choose-your-own-adventure style activity for learning about the cognitive behavioural model in an FD context. Symptom tracking A dedicated ‘symptom tracking’ section, accessible via the navigation bar, allows users to log their daily stomach and mental health symptoms. After a week of consistent logging, a ‘weekly insights’ feature will unlock, displaying potential correlations between mood and stomach symptoms. This section also integrates a thought diary (linked to modules 3 and 4) and an activity calendar (linked to module 5), serving as a centralised tool for logging symptoms, mood and activities relevant to weekly exercises. Flare-up toolkit A ‘flare-up toolkit’ is readily accessible via the navigation bar. This feature is designed to provide users with immediate, in-the-moment support strategies for managing acute symptom flare-ups, and may include exercises such as deep breathing or guided imagery.