Disease management for co-morbid depression and anxiety in diabetes mellitus: design of a randomised controlled trial in primary care

[摘要] BackgroundDepression and anxiety are common co-morbid health problems in patients with type 2 diabetes. Both depression and anxiety are associated with poor glycaemic control and increased risk of poor vascular outcomes and higher mortality rates. Results of previous studies have shown that in clinical practice, treatment of depression and anxiety is far from optimal as these symptoms are frequently overlooked and undertreated.Methods/DesignThis randomised controlled trial will examine the effectiveness of a disease management programme treating symptoms of depression and anxiety in primary care patients with Type 2 diabetes. Patients will be randomized on patient level in 1:1 ratio. Random block sizes of 2 and 4 are used. The disease management programme consists of screening, stepped treatment and monitoring of symptoms (n = 80). This will be compared to care as usual (n = 80).DiscussionThe disease management model for co-morbid depression and anxiety in primary care patients with diabetes is expected to result in reduced symptoms of depression and anxiety, improved quality of life, reduced diabetes specific distress and improved glyceamic control, compared to care as usual.Trial RegistrationDutch Trial Register NTR2626

[发布日期] 2011-12-15

[关键词] diabetes;depression;anxiety;primary care;study protocol;randomised controlled trial;disease management;stepped care;psychological intervention