Evaluation of a Stepped Care Approach to Manage Depression in Diabetes (Ecce_homo)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

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

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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: 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 Psychiatrist; 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.
Active Comparator: Treatment-as-usual; Standard Diabetes Education	Behavioral: Standard Diabetes Education; 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

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. Glycaemic Control (HbA1c) [ Time Frame: 12 month ]
   Mean differences between HbA1c values at baseline and at 12 month follow
6. 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
7. 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

Other Outcome Measures:

1. 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).
2. 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
Bad Mergentheim, Baden-Wuerttemberg, Germany, D-97980

Sponsors and Collaborators

Forschungsinstitut der Diabetes Akademie Mergentheim

German Federal Ministry of Education and Research

German Diabetes Center

Heinrich-Heine University, Duesseldorf

University of Giessen

Helmholtz Zentrum München

Coordination Center for Clinical Trials (KKS)

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care. 2001 Jun;24(6):1069-78.

Pouwer F, Beekman AT, Nijpels G, Dekker JM, Snoek FJ, Kostense PJ, Heine RJ, Deeg DJ. Rates and risks for co-morbid depression in patients with Type 2 diabetes mellitus: results from a community-based study. Diabetologia. 2003 Jul;46(7):892-8. Epub 2003 Jun 18.

Black SA, Markides KS, Ray LA. Depression predicts increased incidence of adverse health outcomes in older Mexican Americans with type 2 diabetes. Diabetes Care. 2003 Oct;26(10):2822-8.

de Groot M, Anderson R, Freedland KE, Clouse RE, Lustman PJ. Association of depression and diabetes complications: a meta-analysis. Psychosom Med. 2001 Jul-Aug;63(4):619-30.

Goldney RD, Phillips PJ, Fisher LJ, Wilson DH. Diabetes, depression, and quality of life: a population study. Diabetes Care. 2004 May;27(5):1066-70.

Egede LE, Zheng D, Simpson K. Comorbid depression is associated with increased health care use and expenditures in individuals with diabetes. Diabetes Care. 2002 Mar;25(3):464-70.

Katon WJ, Rutter C, Simon G, Lin EH, Ludman E, Ciechanowski P, Kinder L, Young B, Von Korff M. The association of comorbid depression with mortality in patients with type 2 diabetes. Diabetes Care. 2005 Nov;28(11):2668-72.

Zhang X, Norris SL, Gregg EW, Cheng YJ, Beckles G, Kahn HS. Depressive symptoms and mortality among persons with and without diabetes. Am J Epidemiol. 2005 Apr 1;161(7):652-60.

Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.

Howren MB, Lamkin DM, Suls J. Associations of depression with C-reactive protein, IL-1, and IL-6: a meta-analysis. Psychosom Med. 2009 Feb;71(2):171-86. doi: 10.1097/PSY.0b013e3181907c1b. Epub 2009 Feb 2. Review.

Pickup JC. Inflammation and activated innate immunity in the pathogenesis of type 2 diabetes. Diabetes Care. 2004 Mar;27(3):813-23. Review.

Pickup JC, Mattock MB. Activation of the innate immune system as a predictor of cardiovascular mortality in Type 2 diabetes mellitus. Diabet Med. 2003 Sep;20(9):723-6.

Larsen CM, Faulenbach M, Vaag A, Vølund A, Ehses JA, Seifert B, Mandrup-Poulsen T, Donath MY. Interleukin-1-receptor antagonist in type 2 diabetes mellitus. N Engl J Med. 2007 Apr 12;356(15):1517-26.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schmitt A, Reimer A, Kulzer B, Haak T, Gahr A, Hermanns N. Assessment of diabetes acceptance can help identify patients with ineffective diabetes self-care and poor diabetes control. Diabet Med. 2014 Nov;31(11):1446-51. doi: 10.1111/dme.12553. Epub 2014 Aug 2.

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
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