Objective
The objective of this study is to determine if offering the fully self-guided, web-based app MyDiaMate as an adjunct to usual care, effectively improves the mental health of adults with Type 1 diabetes, and more so than usual care alone. The focus in this study is on diabetes-related distress, which is assessed using standardized questionnaires at baseline, 3 and 6 months follow-up. The difference in effectiveness between the two groups is determined at the 3-month time point. The study will also look at differences between the groups in terms of emotional wellbeing, fatigue, self-management activities and glycemic control, and explore which participants profit most from using the app.
Background Rationale
Mental health is a priority in care for people with Type 1 diabetes (T1D), but access to psychological services is limited and often not tailored to the needs of people with T1D. The experienced problems are most often related to coping with T1D, not qualifying for treatment and reimbursement in a mental health care setting. Moreover, many people with T1D prefer to overcome their psychological difficulties without involving a professional mental health worker.
Digital self-guided psychological support or e-mental health can help to expand reach and allow large groups of people with T1D access to insights and evidence-based strategies known to be helpful to improve mental health in T1D. For this purpose, the web-based self-guided app MyDiaMate was developed for adults with T1D, and shown to be acceptable, feasible and attractive for people with T1D experiencing diabetes distress. The next step is to test its effectiveness. In view of international dissemination, MyDiaMate will made available in 3 main languages: German, English and Spanish, in addition to Dutch and tested against care as usual in Germany, the UK, Spain and The Netherlands. If MyDiaMate is shown to be effective, it opens up opportunities for broad dissemination of the app, to help promote healthy coping and mental health in people living with T1D.
Description of Project
Mental health is a priority in the care for people with Type 1 diabetes (T1D). However, access to psychological services is generally limited, and if available, often not tailored to the needs of people with T1D. To expand the reach of psychological support, online interventions can be helpful, are safe and carry relatively low costs. More so, if the application is fully self-guided, i.e. not in need of healthcare professionals involvement. In this study the effectiveness of a diabetes type 1 tailored web-based self-help app, called MyDiaMate, will be tested. The app is designed for adults living with T1D and the first of its kind. It was developed and tested in the Netherlands with input from people with T1D and health care professionals, building on Cognitive Behavioral Therapy (CBT) and offering insights and strategies to help improve coping with the burden of T1D and strengthen mental health. The app is focused on improving diabetes distress, with additional modules on emotional well-being and fatigue. MyDiaMate can be used (anonymously) on a smartphone, personal computer or laptop. Personalised feedback and reminders are offered to promote participants' motivation and engagement with the app. The trial will be carried out in 4 countries: Germany, Spain, United Kingdom and the Netherlands. Participants are adults with T1D who experience diabetes distress, which may be accompanied with low well-being and/or fatigue. They are randomized over two conditions: the control group who receives care as usual, and the intervention group, who receive access to MyDiaMate. Participants will fill out questionnaires at baseline, 3 and 6 months follow-up. The effectiveness of MyDiaMate is determined at 3 months, after which the participants in the control group are also given the option to access to MyDiaMate for the remaining 3 months of the trial. The trial will show how effective MyDiaMate is and for whom the use of the app is most beneficial. The primary outcome is change in diabetes distress. Sercondary outcomes are emotional well-being, fatigue, diabetes self-management and indicators of glycemic control. If shown to be effective, MyDiaMate can be made available in English, German and Spanish, allowing for a broad dissemination, reaching a large group of people with T1D across the globe.
Anticipated Outcome
We expect this study to demonstrate that using the app MyDiaMate, as an adjunct to usual care, will show to be more effective in improving diabetes-specific distress than only usual care. We also expect use of the app to have positive effects on emotional wellbeing, fatigue and self-management behaviors, where improvement in these areas is sought by participants. The effect on mental health is expected to be clinically meaningful.
Relevance to T1D
Living with Type 1 diabetes (T1D) is psychologically demanding, not in the least because of the continuous self-managent efforts required to prevent acute and longterm complications. Research has shown that the prevalence of mental health problems is relatively high, in particular diabetes-related distress, complicating daily living and self-management, that deserves special attention in care for people with T1D. However, the mental health needs are often not sufficiently addressed, and only a small group of patients have access to professional psychological support tailored to the needs of people withT1D. Clearly, we need to step up psychological care for people with T1D, and for this pupose we need to employ innovative, user friendly strategies that are effective, and scalable at relatively low costs. To this end, the T1D specific, fully self-guided web-based app MyDiaMate was developed as an adjunct to usual care. It allows people with T1D to work on enhancing healthy coping with T1D and their mental wellbeing, with no need for professional involvement. The app will be tested in English, German, Spanish and Dutch, and if shown to be effective, can be disseminated to help improve healthy coping, mental health and quality of life of many people livingwith T1D.