Depression and Diabetes Control Trial
Condition: Diabetes Mellitus; Affective Disorders; Depression; Depressive Symptoms; Emotional Distress; Diabetes Complications
MeSH terms: Diabetes Mellitus; Diabetes Complications; Depression; Depressive Disorder; Mood Disorders
Study type: Interventional

Summary: 
      This randomised controlled trial evaluates a cognitive-behavioural intervention for diabetes
      patients with suboptimal glycaemic control and comorbid depressive symptoms and/or diabetes
      distress. The main outcome is the improvement of suboptimal glycaemic control (HbA1c).
      Secondary outcomes are effects on depressive symptoms, diabetes distress, self-care
      behaviour, diabetes acceptance and quality of life. The treatment group will be treated with
      a cognitive-behavioural group treatment comprising specific interventions to improve
      glycaemic control and reduce diabetes distress as well as depressive symptoms. The control
      group will receive treatment-as-usual. A total of 212 study participants will be included. A
      secondary study objective is to analyse associations of suboptimal glycaemic control,
      depressive symptoms and diabetes distress with inflammatory markers.
    

Detailed description: 
      Suboptimal glycaemic control is an established risk factor for the development of serious
      long-term complications of diabetes. Moreover, it is associated with elevated risks of
      significant hyperglycaemic acute events such as hyperosmolar hyperglycemic state or diabetic
      ketoacidosis. Hence, patients with diabetes and persistent suboptimal glycaemic control are
      at higher risk of having a rather poor prognosis.

      Besides physiological and medical factors, psychological problems have been found to predict
      suboptimal glycaemic control. A number of studies found depressive symptoms to be
      independently associated with hyperglycaemia. Others focussed on diabetes-specific affective
      problems - the so called diabetes distress - and suggested this factor to be of great
      importance. Finally, some studies found that depressive symptoms and diabetes distress may
      interact, with the coocurrence of these factors being associated with the highest risk or
      suboptimal glycaemic control. The results correspond to other findings suggesting that both
      depressive symptoms and diabetes distress are often associated with reduced diabetes
      self-care, which can explain the associations of those factors with hyperglycaemia.

      On the other hand, suboptimal glycaemic control could also be an explanation for affective
      problems - either mediated by physiological mechanisms or psychological ones, e.g.
      dissatisfaction or guilt. Hence, it is valid to assume that the link between depressive
      symptoms and/or diabetes distress may be bidirectional - although evidence to support this
      assumption is missing.

      Following this evidence and background, the investigators designed the a to analyse the
      relationships between suboptimal glycaemic control, depressive symptoms and diabetes distress
      in diabetes using a prospective study design. The study is a randomized trial in which a
      cognitive-behavioural group treatment is compared to a treatment-as-usual condition (standard
      diabetes education) regarding their efficacy in improving suboptimal glycaemic control. 212
      diabetes patients with suboptimal glycaemic control (HbA1c value > 7.5%) and elevated
      depressive symptoms (Center for Epidemiologic Studies Depressions Scale score ≥ 16) and/or
      elevated diabetes distress (Problem Areas In Diabetes Scale score ≥ 40) will be randomly
      assigned to either the treatment group or treatment-as-usual. The primary outcome is the
      improvement of suboptimal glycaemic control (reduction of HbA1c) in the 12-month follow-up.
      As secondary outcomes positive baseline-to-follow up changes regarding depressive symptoms,
      diabetes distress, diabetes self-care behaviour, diabetes acceptance and quality of life are
      assessed.

      A second study objective is to analyse cross-sectional and prospective associations of
      suboptimal glycaemic control, depressive symptoms and diabetes distress with serum levels of
      the following inflammatory markers: hsCRP, IL-6, IL-18, IL-1Ra, MCP-1 and Adiponectin.
      Potential effects of the treatment groups on these markers will also be examined.
    

Intervention name(s): Diabetes-related affective problems analysis; Goal setting towards improvement of glycaemic control; Diabetes-specific problem-solving therapy; Interventions to increase diabetes treatment motivation; Activation of personal and social resources; Reduction of barriers to self-care/glycaemic control; Cognitive restructuring of diabetes-related problems; Goal definition regarding self-care/glycaemia/well-being; Health care and specific topics (e. g. blood pressure); Healthy foods, cooking recommendations, recipes; Sports, activities and exercise; Foot care: exercises, care & control, injuries, neuropathy; Diabetes complications; Social aspects of living with diabetes
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Analysis of diabetes-related affective problems with regard to suboptimal glycaemic control; Discussing and setting goals regarding improvements of suboptimal glycaemic control, depressive symptoms and diabetes distress; Diabetes-specific problem-solving therapy with main focus on suboptimal glycaemic control, depressive symptoms and diabetes distress; Interventions to increase diabetes treatment motivation in order to achieve improvements of glycaemic control as well as recovery from affective problems; Activation of personal and social resources with a view to diabetes control and affective problems; Definition and reduction of barriers to adequate diabetes self-care behaviour as well as good glycaemic control; Cognitive restructuring of diabetes-related problems such as suboptimal glycaemic control and diabetes-related affective problems; Goal definition and agreement regarding diabetes self-care behaviour, optimal glycaemic control and activities supporting well-being and recovery from affective symptoms; Education on health care and specific topics (e. g. blood pressure); Education on healthy and unhealthy foods, cooking and recipes; Education on sports, activities and exercise; Education on foot care: exercises, care and control, injuries, and diabetic neuropathy; Education on diabetes complications; Education on social aspects of living with diabetes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus; Affective disorders; Depressive symptoms; Diabetes distress; Hyperglycaemia; Dysglycaemia; Glycaemic control; Self-care behaviour; Quality of Life; Diabetes acceptance; Diabetes complications; Low-grade inflammation; Inflammatory markers; Stress reactivity; Health-care costs