Evaluation of a Stepped Care Approach to Manage Depression in Diabetes
Condition: Major Depressive Disorder; Minor Depressive Disorder; Sub-Threshold Depression; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The study examines the efficacy of a stepped care approach for depressed diabetes patients
      (first study objective). 256 patients with diabetes and comorbid subthreshold or clinical
      depression will be randomly assigned to either a stepped care approach or a
      treatment-as-usual condition. The stepped care approach consists of three treatment steps
      comprising diabetes-specific cognitive-behavioral therapy (CBT) (group), depression-specific
      CBT (single), and psychotherapeutic and/or psychiatric treatment (single). Patients assigned
      to the stepped care approach will be treated stepwise until a clinically significant
      reduction of depressive symptoms is attained or all three treatment steps are passed.

      The primary outcome of the first study objective is a clinically significant reduction of
      depressive symptoms in the 12-month follow-up. Secondary outcomes are reduction of
      diabetes-related distress and improvement of well-being, health-related quality of life,
      diabetes acceptance, diabetes self-care, and glycaemic control. Additionally, cost-benefit
      analyses will be performed.

      The second study objective is to analyse associations between diabetes, depression, and the
      serum levels of inflammatory markers.

      The third study objective is to analyse the courses of depressive conditions in diabetes with
      regard to recovery rates and incidence of major depression.
    

Detailed description: 
      Compared to persons without diabetes, rates of depressive disorders and mood are doubled in
      diabetes patients. Epidemiologic studies have shown point prevalence rates of 10 - 14% for
      major depressive disorder and an additional proportion of almost 20% with subthreshold
      depression (defined as elevated depressive symptoms without meeting criteria for a specified
      clinical disorder). Depression and subthreshold depression in diabetes are associated with
      reduced quality of life, increased diabetes-related distress, and elevated health care costs.
      Furthermore, depression as well as subthreshold depression seem to be major barriers to an
      effective self-management of the disease and have been associated with reduced glycaemic
      control and hyperglycaemia. Both conditions seem to be independent prognostic factors for
      subsequent morbidity and mortality in diabetes.

      Depressive conditions are commonly treated with psychotherapeutic or pharmacologic
      antidepressive therapies. Since the majority of diabetes patients is suffering from
      subthreshold depression, evaluated and suitable specific intervention concepts are rare.
      Moreover, the large variation of symptom levels of depressive patient groups suggests that
      different types of treatment with different treatment intensities may be required to match
      individual demands. The issue of 'optimal' treatment also regards concerns about
      overtreatment and undertreatment of particular patient groups with depressive conditions.
      Thus, an successive order of treatment steps of increasing intensity appears useful. Since
      depression in diabetes often is associated with high diabetes-related problems and distress,
      diabetes-specific as well as depression-specific interventions may be required.

      We developed a stepped care approach with three treatment steps comprising diabetes-specific
      CBT (group), depression-specific CBT (single), and psychotherapeutic and/or psychiatric
      treatment (single).

      The study is a randomized efficacy trial in which the efficacy of the stepped care approach
      is compared to a treatment-as-usual condition (standard diabetes education). 256 patients
      with diabetes and comorbid subthreshold or clinical depression will be randomly assigned to
      either the stepped care approach or the treatment-as-usual condition. Patients assigned to
      the stepped care approach will be treated stepwise until a clinically significant reduction
      of depressive symptoms is attained or all three treatment steps are passed.

      The primary outcome is a clinically significant reduction of depressive symptoms in the
      12-month follow-up. Secondary outcomes are reduction of diabetes-related distress and
      improvement of well-being, health-related quality of life, diabetes acceptance, diabetes
      self-care, and glycaemic control. The decisive measurement of this outcomes are conducted 12
      months after the treatment (12 month follow up). Additionally, cost-benefit analyses will be
      performed.

      Besides testing the efficacy of the stepped care approach (first objective), there are two
      additional study objectives:

      The second study objective is to analyse associations between diabetes, depression, and the
      serum levels of inflammatory markers (C-reactive protein (CRP), Interleukin (IL)-6, IL-18,
      IL-1Ra, Adiponectin, Monocyte chemoattractant protein (MCP)-1). Additionally, the impact of
      depression treatment on the levels of these markers will be examined.

      The third study objective is to analyse the courses of depressive conditions in diabetes with
      regard to recovery rates and incidence of major depression in subclinically or clinically
      depressed diabetes patients treated as usual vs. given an intervention.
    

Intervention name(s): Step 1: Diabetes-Specific CBT (5 group sessions); Step 2: Depression-Specific CBT (6 single sessions); Step 3: Referral to Psychotherapist and/or Psychiatrist; Standard Diabetes Education
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Diabetes-Specific CBT (5 group sessions) focusing on diabetes-related problems and distress ('DIAMOS - Strengthening Diabetes Motivation').
Includes:
Diabetes problem analysis/ definition
Diabetes problem solving intervention
Cognitive restructuring of diabetes problems
Activation of personal and social resources
Goal definition and agreement; Depression-Specific CBT (6 single sessions) focusing on depressive cognitions and affective problems (manualised).
Includes:
Functional explanatory model of depression
Cognitive restructuring of negative thoughts
Practice of alternative beneficial thoughts
Specific cognitive interventions regarding self-criticism, guilt, low self-esteem, fear, and inactivity.; Non-responders to previous treatment steps will be referred to an psychotherapist and/or psychiatrist for intensified treatment. Treatments procedures will be monitored and interventions will be scored to enable the evaluation of treatment effects.; Standard diabetes education and professional care.
Includes:
Health care and specific topics (e. g. blood pressure)
Diabetes complications
Healthy and unhealthy foods, cooking recommendations and recipes
Foot care: exercises, care and control, injuries, and diabetic neuropathy
Sports, activities and exercise
Social aspects of living with diabetes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depression; Minor Depression; Sub-Threshold Depression; Affective Condition; Mood Disorder; Light Affective Disorder; Subclinical Depressive Symptoms; Diabetes Mellitus; Diabetes-Related Distress; Self-Care Behaviour; Glycaemic Control; Inflammatory Markers