Abstract
BackgroundA diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder. The combined diseases have a wide range of adverse outcomes, such as a lower quality of life, poorer diabetes outcomes and increased healthcare utilisation. Diabetes patients with depression can be treated effectively with psychotherapy, but access to psychological care is limited. In this study we will examine the efficacy and cost-effectiveness of a newly developed web-based intervention (GET.ON Mood Enhancer Diabetes) for people with diabetes and comorbid depressive symptoms.Methods/DesignA two-arm randomised controlled trial will be conducted. Adults with diabetes (type 1 or type 2) with increased depression scores (> 22 on the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) will be included. Eligible participants will be recruited through advertisement in diabetes patient journals and via a large-scale German health insurance company. The participants will be randomly assigned to either a 6-week minimally guided web-based self-help program or an online psychoeducation program on depression. The study will include 260 participants, which will enable us to detect a statistically significant difference with a group effect size of d = 0.35 at a power of 80% and a significance level of p = 0.05. The primary outcome measure will be the level of depression as assessed by the CES-D. The secondary outcome measures will be: diabetes-specific emotional distress, glycaemic control, self-management behaviour and the participants’ satisfaction with the intervention. Online self-assessments will be collected at baseline and after a 2 months period, with additional follow-up measurements 6 and 12 months after randomisation. The data will be analysed on an intention-to-treat basis and per protocol. In addition, we will conduct an economic evaluation from a societal perspective.DiscussionIf this intervention is shown to be cost-effective, it has considerable potential for implementing psychological care for large numbers of people with diabetes and comorbid depression in routine practice and improve health outcomes.Trial registrationGerman Clinical Trial Register (DRKS): DRKS00004748.
Highlights
A diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder
A meta-analysis found that approximately 11% of all people with diabetes, that were assessed through standardised diagnostic interviews, suffered from depression
Improving efficacy and adherence Taking into account that non-compliance presents as a problem in web-based programs [38], in many depressed people [36,37] and people with diabetes [35], we developed two ways to increase the number of sessions completed by the intervention group
Summary
A diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder. A meta-analysis found that approximately 11% of all people with diabetes, that were assessed through standardised diagnostic interviews, suffered from depression. 31% of all people with diabetes reported themselves as depressive when assessed through self-report questionnaires [2]. In comparison to the general population, a diagnosis of diabetes type 1 or type 2 doubles the odds of a comorbid depressive disorder [2]. People affected by comorbid depression exhibit lower quality of life [3,4], poorer adherence to diabetes self-care practises [5], worse glycaemic control [6] and greater risk of diabetes-related complications [7]. Studies have shown that indirect and direct health care costs are greater among adults with diabetes and depression compared with adults with diabetes only [10,11,12,13]
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