Major Depressive Disorder | Evaluation of a Stepped Care Approach to Manage Depression in Diabetes

Major Depressive Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Age >=18 and <=70 - Diabetes mellitus - Elevated depressive symptoms (CES-D score >=16) and/or elevated diabetes-related distress (PAID score >=40) - Sufficient language skills (German) - Written informed consent Exclusion Criteria: - Severe depressive episode (F32.2/ F32.3) - Current psychotherapeutic/ psychiatric treatment - Current antidepressive medication - Suicidal intention - Current schizophrenia/ psychotic disorder, specified eating disorder, bipolar disorder, addictive disorder, personality disorder - Severe physical illness (i.e. cancer, multiple sclerosis, dementia) - Terminal illness - Bedriddenness - Guardianship

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Major Depressive Disorder

Minor Depressive Disorder

Sub-Threshold Depression

Diabetes Mellitus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Step 1: Diabetes-Specific CBT (5 group sessions)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

Behavioral:Step 2: Depression-Specific CBT (6 single sessions)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.

Behavioral:Step 3: Referral to Psychotherapist and/or PsychiatristNon-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.

Behavioral:Standard Diabetes EducationStandard 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Stepped Care Approach for DepressionStep 1: Diabetes-Specific CBT (5 group sessions) Step 2: Depression-Specific CBT (6 single sessions) Step 3: Referral to Psychotherapist and/or Psychiatrist

Treatment-as-usualStandard Diabetes Education

Study Status


Start Date: February 2012

Completed Date: November 2015

Phase: N/A

Type: Interventional


Primary Outcome: Depressive Mood - Hamilton Rating Scale for Depression (HAMD)

Secondary Outcome: Diabetes-Related Distress - The Problem Areas in Diabetes Questionnaire (PAID)

Study sponsors, principal investigator, and references

Principal Investigator: Bernhard Kulzer, PD Dr.

Lead Sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim

Collaborator: German Federal Ministry of Education and Research

More information:

Hermanns N, Kulzer B, Krichbaum M, Kubiak T, Haak T. Affective and anxiety disorders in a German sample of diabetic patients: prevalence, comorbidity and risk factors. Diabet Med. 2005 Mar;22(3):293-300.

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