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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
German Diabetes Center
Heinrich-Heine University, Duesseldorf
University of Giessen
Helmholtz Zentrum Muenchen, German Research Center for Environmental Health
Coordination Center for Clinical Trials (KKS) Duesseldorf
Information provided by (Responsible Party):
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier:
NCT01812291
First received: March 14, 2013
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Forschungsinstitut der Diabetes Akademie Mergentheim:

Primary Outcome Measures:
  • Depressive Mood - Hamilton Rating Scale for Depression (HAMD) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Mean differences between SDSCA scores at baseline and at 12 month follow

  • Glycaemic Control (HbA1c) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Mean differences between DSMQ scores at baseline and at 12 month follow


Other Outcome Measures:
  • Inflammatory Markers [ Time Frame: Baseline, 12 month follow up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Difference in rates of major depression according to ICD-10 criteria between baseline and 12 months follow up


Estimated Enrollment: 256
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812291

Contacts
Contact: Bernhard Kulzer, PD Dr. +49-7931/ 594 ext 151 kulzer@diabetes-zentrum.de
Contact: Norbert Hermanns, Prof. Dr. +49-7931/ 594 ext 553 hermanns@diabetes-zentrum.de

Locations
Germany
Forschungsinstitut der Diabetes Akademie Mergentheim e. V. Recruiting
Bad Mergentheim, Baden-Wuerttemberg, Germany, D-97980
Contact: Bernhard Kulzer, PD Dr.    +49-7931/ 594 ext 151    kulzer@diabetes-zentrum.de   
Contact: Norbert Hermanns, Prof. Dr.    +49-7931/ 594 ext 553    hermanns@diabetes-zentrum.de   
Principal Investigator: Bernhard Kulzer, PD. Dr.         
Principal Investigator: Norbert Hermanns, Prof. Dr.         
Sub-Investigator: Andreas Schmitt, MPsych         
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 Muenchen, German Research Center for Environmental Health
Coordination Center for Clinical Trials (KKS) Duesseldorf
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

Publications:

Responsible Party: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier: NCT01812291     History of Changes
Other Study ID Numbers: FKZ 01GI1107
Study First Received: March 14, 2013
Last Updated: February 20, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by 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
Diabetes Mellitus
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 11, 2014