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

September 9, 2022 updated by: Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim

Efficacy of a Stepped Care Approach to Manage Depression in Diabetic Patients and Putative Inflammatory Mechanisms Between Diabetes and Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 month
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
12 month
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
12 month
Glycaemic Control (HbA1c)
Time Frame: 12 month
Mean differences between HbA1c values at baseline and at 12 month follow
12 month
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
12 month
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
12 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forschungsinstitut der Diabetes Akademie Mergentheim

Collaborators

German Federal Ministry of Education and Research
Heinrich-Heine University, Duesseldorf
Helmholtz Zentrum München
University of Giessen
German Diabetes Center
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKZ 01GI1107

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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