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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
Sponsor:
Collaborators:
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)
Information provided by (Responsible Party):
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim

Tracking Information
First Submitted Date  ICMJE March 14, 2013
First Posted Date  ICMJE March 18, 2013
Last Update Posted Date January 14, 2016
Study Start Date  ICMJE February 2012
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2013)
Depressive Mood (HAMD) [ Time Frame: Baseline, 12 month follow up ]
The Hamilton Rating Scale for Depression (HAMD) is used to assess levels of depressive mood. The decisive measurement of this primary outcome variable is conducted 12 months after the treatment (12 month follow up). The difference of the HAMD scores between baseline and 12 month follow up is calculated.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2013)
  • Diabetes-Related Distress (PAID) [ Time Frame: Baseline, 12 month follow up ]
    The Problem Areas in Diabetes (PAID) Questionnaire is used to assess levels of diabetes-related distress. The decisive measurement of this secondary outcome variable is conducted 12 months after the treatment (12 month follow up). The difference of the PAID scores between baseline and 12 month follow up is calculated.
  • Emotional Well-Being (WHO-5) [ Time Frame: Baseline, 12 month follow up ]
    The WHO-5 Well-being Index (WHO-5) is used to assess levels of emotional well-being. The decisive measurement of this secondary outcome variable is conducted 12 months after the treatment (12 month follow up). The difference of the WHO-5 scores between baseline and 12 month follow up is calculated.
  • Health-Related Quality of Life (SF-36, EQ-5D) [ Time Frame: Baseline, 12 month follow up ]
    The Short Form-36 Health Survey (SF-36) and the EuroQol-5D (EQ-5D) are used to assess health-related quality of life. The decisive measurement of this secondary outcome variable is conducted 12 months after the treatment (12 month follow up). The differences of the SF-36 and EQ-5D scores between baseline and 12 month follow up are calculated.
  • Diabetes Self-Care (SDSCA, DSMQ) [ Time Frame: Baseline, 12 month follow up ]
    The Summary of Diabetes Self-Care Activities Measure (SDSCA) and the Diabetes Self-Management Questionnaire (DSMQ) are used to assess diabetes self-care. The decisive measurement of this secondary outcome variable is conducted 12 months after the treatment (12 month follow up). The differences of the SDSCA and DSMQ scores between baseline and 12 month follow up are calculated.
  • Glycaemic Control (HbA1c) [ Time Frame: Baseline, 12 month follow up ]
    HbA1c values are analysed to assess glycaemic control. The decisive measurement of this secondary outcome variable is conducted 12 months after the treatment (12 month follow up). The differences of the HbA1c values between baseline and 12 month follow up are calculated.
Current Other Pre-specified Outcome Measures
 (submitted: February 20, 2014)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: March 14, 2013)
  • 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).
  • Rate of Major Depression [ Time Frame: Baseline, 12 months follow up ]
    Rates of major depression according to ICD-10 criteria are assessed to enable analyses with regard to the third study objective - incidence and recovery rates of major depression. The measurement of this additional outcome variable is conducted twice, at baseline and 12 months after the treatment (12 month follow up).
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Stepped Care Approach to Manage Depression in Diabetes
Official Title  ICMJE Efficacy of a Stepped Care Approach to Manage Depression in Diabetic Patients and Putative Inflammatory Mechanisms Between Diabetes and Depression
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Minor Depressive Disorder
  • Sub-Threshold Depression
  • Diabetes Mellitus
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • 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

    Interventions:
    • 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
  • Active Comparator: Treatment-as-usual
    Standard Diabetes Education
    Intervention: Behavioral: Standard Diabetes Education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2015)
260
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2013)
256
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01812291
Other Study ID Numbers  ICMJE FKZ 01GI1107
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
Study Sponsor  ICMJE Forschungsinstitut der Diabetes Akademie Mergentheim
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account Forschungsinstitut der Diabetes Akademie Mergentheim
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP