Evaluation of a Stepped Care Approach to Manage Depression in Diabetes (Ecce_homo)
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ClinicalTrials.gov Identifier: NCT01812291 |
Recruitment Status
:
Completed
First Posted
: March 18, 2013
Last Update Posted
: January 14, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder Minor Depressive Disorder Sub-Threshold Depression Diabetes Mellitus | Behavioral: Step 1: Diabetes-Specific CBT (5 group sessions) Behavioral: Step 2: Depression-Specific CBT (6 single sessions) Behavioral: Step 3: Referral to Psychotherapist and/or Psychiatrist Behavioral: Standard Diabetes Education | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 260 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of a Stepped Care Approach to Manage Depression in Diabetic Patients and Putative Inflammatory Mechanisms Between Diabetes and Depression |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | November 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Stepped Care Approach for Depression
Step 1: Diabetes-Specific CBT (5 group sessions) Step 2: Depression-Specific CBT (6 single sessions) Step 3: Referral to Psychotherapist and/or Psychiatrist |
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:
Depression-Specific CBT (6 single sessions) focusing on depressive cognitions and affective problems (manualised). Includes:
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.
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Active Comparator: Treatment-as-usual
Standard Diabetes Education
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Behavioral: Standard Diabetes Education
Standard diabetes education and professional care. Includes:
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- Depressive Mood - Hamilton Rating Scale for Depression (HAMD) [ Time Frame: 12 month ]Mean difference between HAMD scores at baseline and at 12 month follow up
- Diabetes-Related Distress - The Problem Areas in Diabetes Questionnaire (PAID) [ Time Frame: 12 months ]Mean difference between PAID scores at baseline and at 12 month follow up
- Psychological/ Emotional Well-Being - The WHO-5 Well-being Index (WHO-5) [ Time Frame: 12 month ]Mean difference between WHO-5 scores at baseline and at 12 month follow up
- Health-Related Quality of Life - The Short Form-36 Health Survey (SF-36) [ Time Frame: 12 month ]Mean difference between SF-36 scores at baseline and at 12 month follow up
- Diabetes Self-Care Behavior - The Summary of Diabetes Self-Care Activities Measure (SDSCA) [ Time Frame: 12 month ]Mean differences between SDSCA scores at baseline and at 12 month follow
- Glycaemic Control (HbA1c) [ Time Frame: 12 month ]Mean differences between HbA1c values at baseline and at 12 month follow
- Health-Related Quality of Life - The EuroQol-5D (EQ-5D) [ Time Frame: 12 month ]Mean differences between EQ-5D scores at baseline and at 12 month follow
- Diabetes Self-Care Behavior - The Diabetes Self-Management Questionnaire (DSMQ) [ Time Frame: 12 month ]Mean differences between DSMQ scores at baseline and at 12 month follow
- Inflammatory Markers [ Time Frame: Baseline, 12 month follow up ]Serum levels of the inflammatory markers CRP, IL-6, IL-18, IL-1Ra, Adiponectin, MCP-1 are assessed to enable analyses with regard to the second study objective - associations between diabetes, depression, and inflammation. The measurement of this additional outcome variable is conducted twice, at baseline and 12 months after the treatment (12 month follow up).
- Major Depressive Disorder [ Time Frame: 12 months ]Difference in rates of major depression according to ICD-10 criteria between baseline and 12 months follow up

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812291
Germany | |
Forschungsinstitut der Diabetes Akademie Mergentheim e. V. | |
Bad Mergentheim, Baden-Wuerttemberg, Germany, D-97980 |
Principal Investigator: | Bernhard Kulzer, PD Dr. | Forschungsinstitut der Diabetes Akademie Mergentheim | |
Principal Investigator: | Norbert Hermanns, Prof. Dr. | Forschungsinstitut der Diabetes Akademie Mergentheim | |
Study Director: | Thomas Haak, Prof. Dr. | Forschungsinstitut der Diabetes Akademie Mergentheim | |
Principal Investigator: | Johannes Kruse, Prof. Dr. | University of Giessen |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim |
ClinicalTrials.gov Identifier: | NCT01812291 History of Changes |
Other Study ID Numbers: |
FKZ 01GI1107 |
First Posted: | March 18, 2013 Key Record Dates |
Last Update Posted: | January 14, 2016 |
Last Verified: | January 2016 |
Keywords provided by Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim:
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 |
Additional relevant MeSH terms:
Depression Depressive Disorder Depressive Disorder, Major Disease Diabetes Mellitus Pathologic Processes |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Behavioral Symptoms Mood Disorders Mental Disorders |