Ecce_homo: Evaluation of a Stepped Care Approach to Manage Depression in Diabetes
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
Primary Outcome Measures
- Depressive Mood - Hamilton Rating Scale for Depression (HAMD) [12 month]
Mean difference between HAMD scores at baseline and at 12 month follow up
Secondary Outcome Measures
- Diabetes-Related Distress - The Problem Areas in Diabetes Questionnaire (PAID) [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) [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) [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) [12 month]
Mean differences between SDSCA scores at baseline and at 12 month follow
- Glycaemic Control (HbA1c) [12 month]
Mean differences between HbA1c values at baseline and at 12 month follow
- Health-Related Quality of Life - The EuroQol-5D (EQ-5D) [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) [12 month]
Mean differences between DSMQ scores at baseline and at 12 month follow
Other Outcome Measures
- Inflammatory Markers [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 [12 months]
Difference in rates of major depression according to ICD-10 criteria between baseline and 12 months follow up
Eligibility Criteria
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
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Severe physical illness (i.e. cancer, multiple sclerosis, dementia)
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Terminal illness
-
Bedriddenness
-
Guardianship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Pickup JC. Inflammation and activated innate immunity in the pathogenesis of type 2 diabetes. Diabetes Care. 2004 Mar;27(3):813-23. Review.
- 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.
- 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.
- FKZ 01GI1107