Objective
Our mission is to improve the quality of life of people with T1D all over the world, by means of high quality research that taps into unmet care needs. The proposed study therefore has the following objectives:
First objective: To translate and culturally adapt DiaBetterMood (DBM), an online diabetes-specific intervention that targets depression, for use in Argentinian and Brazilian people with T1D.
Second objective: To determine the effectiveness of DBM over time in adults with T1D relative to care as usual (CAU), with depression as primary outcome and diabetes distress and cost effectiveness as a secondary outcomes.
Third objective: To determine through interviews with key stakeholders what would be needed for successful implementation after the trial (in case the results of the RCT confirm effectiveness of DBM in Argentina and Brazil).
Our mission does not stop here. During the study, we will also explore whether the newly developed versions of DiaBetterMood can be adapted and used by individuals with T1D who live in other countries where the Spanish or Portuguese language is spoken.
Background Rationale
A large number of studies have convincingly shown that approximately 30% of the people with T1D report elevated levels of depression and stress. These mental health problems can be treated, but a key problem is that access to psychological care is limited in many countries, due to lack of staff, insufficient health care budgets and costs for patients. Providing web-based care could be a solution for this problem. A recent systematic review of trials has investigated whether psychological e-health interventions improve depression and diabetes distress in adults with diabetes. Results from seven different studies were included (from Australia, Germany, Netherlands and USA). The study showed that psychological e-health interventions were mainly CBT-based, and appeared to be effective for the treatment of depression in people with diabetes. However, it was also concluded that “the scientific evidence reported to date is still very limited”. To date, the seven RCTs that have been conducted merely focused on DM2 (57%) or mixed samples (DM1 or DM2, 43%). None of the studies focused on depression in DM1, none of the studies was conducted in a developing country. Moreover, economical evaluations were lacking.
The diabetes-specific DiaBetterMood intervention not only had a positive impact on depression, but also reduced diabetes distress levels. In their systematic review with meta-analysis, Jenkinson et al included 22 RCT investigating the efficacy of CBT and third-wave CBT interventions on diabetes-related distress. CBT for diabetes-related distress significantly reduced distress and depression. CBT interventions that included a digital component, were delivered by a psychological practitioner, and included behavioral activation bolstered the effects on diabetes-related distress.
Description of Project
Type 1 diabetes (T1D) is a demanding chronic condition that requires intensive 24/7 self-care. Having to manage T1D, in addition to other sources of stress in life, can seriously impact psychological functioning. Review studies have convincingly shown that approximately 30% of the people with T1D report elevated depression or psychological stress. Depression is not only associated with seriously impaired quality of life, it is also an important risk factor for suboptimal self-care, higher HbA1c levels, the development of micro- and macrovascular complications, higher health care costs and early mortality. There is ADA/EASD-consensus that psychological support and treatment should be an integral part of the care for individuals with T1D. However, access to psychological services is very limited in many countries around the globe, mainly due to economic reasons.
One promising solution consists of online psychological interventions, that have the potential of reaching and impacting a large number of people with T1D, with minimal professional involvement. Online interventions for depression have shown equal efficacy as face-to-face therapy, with considerable advantages: no waiting list, no travel time for patients, high flexibility regarding the timing of therapy, and low costs once the intervention is developed. In The Netherlands, a diabetes-specific web-based intervention has been developed, named “DiaBetterMood”, an 8-week moderated self-help course based on Cognitive Behavior Therapy (CBT). A randomized controlled trial in 255 adults with diabetes and with elevated depressive symptoms showed that DiaBetterMood was effective in reducing both depressive symptoms and diabetes-specific emotional distress , and across different levels of severity. So far, psychological interventions that aim to reduce depression and/or diabetes-distress have been developed and tested in Europe and North America. Such interventions have not been adapted for or use in Latin America, including large countries such as Argentina and Brazil, despite their high T1D numbers, disperse health coverage, and limited T1D-reladed mental care. Given the urgent need for implementation of effective diabetes-specific depression interventions in these countries, we aim to translate, culturally adapt, and test the efficacy (RCT) with careful implementation of DiaBetterMood in Argentina and Brazil. This will be done with close involvement of people with T1D and health care providers throughout the process. Structured interviews with clinicians and individuals with T1D will be conducted to identify where changes need to be made and new videos will be created. These first steps are necessary to complete before testing the efficacy and implementation possibilities of DiaBetterMood in Argentina and Brazil. This cutting-edge 4-year project, coordinated by University of Southern Denmark, with substantial input from a prestigious group of international researchers, will be the first of its kind, addressing the unmet psychological needs of people with T1D in two large Latin American countries, with potentially large reach and impact. On the longer term, we also aim to make the DiaBetterMood intervention available for (free) use in other Latin-American T1D communities, e.g. in Mexico, Columbia, or USA.
Anticipated Outcome
In an earlier randomized controlled trial, the Dutch version of DiaBetterMood significantly reduced depression and diabetes distress. We anticipate that the Brazilian-Portuguese- and the Spanish adaptations of DiaBetterMood will also have beneficial effects on both depression and diabetes distress, and also have beneficial effects on costs. This would mean that we have a solution for a large unmet care need of a large number of people with T1D and co-morbid depression, who live in Argentina or Brazil. It would also mean that we make an intervention available that is relatively cheap to maintain form health care systems. This would also mean that we could make it available for people with T1D who speak Spanish or Portuguese who live in other countries, such as Mexico, USA or Colombia.
Relevance to T1D
A common co-morbidity in T1D requires our attention. Approximately 30% of the people with T1D suffer from co-morbid depression and psychological stress. The combination T1D and depression is an unfavorable one, as this combination not only has a strong negative impact on quality of life. It is also associated with less optimal glycemic control, a substantial higher risk to develop diabetes complications and higher mortality rates. An essential clinical problem is that depression and diabetes distress often remain untreated, even though evidence-based treatments for depression and diabetes distress are available. Access to (diabetes-tailored) psychological care for these problems is scarce, mainly due to budget restraints and long waiting lists. Particularly those with a private health insurance have (some) access to mental health care. The treatment gap for mental disorders in Argentina and Brazil is mainly related to a) financial hardship and b) mental health care not being available or c) long waiting lists (ref), while other factors such as stigma related to mental health may also play a role.
E-health might be a good solution for this problem. Online mental e-health interventions are well suited for people with T1D and mild-moderate depression and elevated diabetes distress. Once the intervention is developed, it can be used at home, anonymously, with less stigma threat, at a preferred time and pace, there is no need to travel to a clinic. A major advantage is that e-health interventions can reach a large number of people against very low costs. This clearly makes psychological e-health interventions attractive from a public health perspective. Timely access to online interventions may also help to prevent that mild symptoms develop into more severe mental health problems, such as an anxiety disorder or major depression, two prevalent comorbid mental health problems in T1D. E-health interventions are also suitable for use in the Latin American countries. According to the International Telecommunication Union World Telecommunication/ICT Indicators Database (year: 2021), 81% of households in Brazil had access to internet, for Argentina this percentage was 87%.
DiaBetterMood (DBM) is an 8-week, online moderated self-help course, based on the principles of Cognitive Behavior Therapy (CBT). The intervention was developed by our team (Snoek, Pouwer) in The Netherlands. A large randomized controlled trial convincingly showed that DBM was effective in reducing both depressive symptoms and diabetes-specific emotional distress, and across different levels of severity. This cutting-edge 4-year project, coordinated by University of Southern Denmark, with substantial input from a prestigious group of international researchers, will be the first of its kind, addressing the unmet psychological needs of people with T1D in two large Latin American countries, with potentially large reach and impact. On the longer term, we also aim to make the DiaBetterMood intervention available for (free) use in other Latin-American T1D communities, e.g. in Mexico, Columbia, or USA.