Evaluation of a Stepped Care Approach to Manage Depression in Diabetes

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.

Conditions

• Major Depressive Disorder
• Minor Depressive Disorder
• Sub-Threshold Depression
• Diabetes Mellitus

Interventions

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

Sponsors & Collaborators

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• German Diabetes Center

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• University of Giessen

  collaborator OTHER

• Helmholtz Zentrum München

  collaborator INDUSTRY

• Coordination Center for Clinical Trials (KKS)

  collaborator UNKNOWN

• Forschungsinstitut der Diabetes Akademie Mergentheim

  lead OTHER

Principal Investigators

• Bernhard Kulzer, PD Dr. · Forschungsinstitut der Diabetes Akademie Mergentheim

• Norbert Hermanns, Prof. Dr. · Forschungsinstitut der Diabetes Akademie Mergentheim

• Thomas Haak, Prof. Dr. · Forschungsinstitut der Diabetes Akademie Mergentheim

• Johannes Kruse, Prof. Dr. · University of Giessen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2015-11-30

Completion

2015-11-30

Countries

• Germany

Study Locations