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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01812291
Other study ID # FKZ 01GI1107
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2012
Est. completion date November 2015

Study information

Verified date September 2022
Source Forschungsinstitut der Diabetes Akademie Mergentheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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Locations

Country Name City State
Germany Forschungsinstitut der Diabetes Akademie Mergentheim e. V. Bad Mergentheim Baden-Wuerttemberg

Sponsors (7)

Lead Sponsor Collaborator
Forschungsinstitut der Diabetes Akademie Mergentheim Coordination Center for Clinical Trials (KKS), German Diabetes Center, German Federal Ministry of Education and Research, Heinrich-Heine University, Duesseldorf, Helmholtz Zentrum München, University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Herder C, Schmitt A, Budden F, Reimer A, Kulzer B, Roden M, Haak T, Hermanns N. Association between pro- and anti-inflammatory cytokines and depressive symptoms in patients with diabetes-potential differences by diabetes type and depression scores. Transl — View Citation

Herder C, Schmitt A, Budden F, Reimer A, Kulzer B, Roden M, Haak T, Hermanns N. Longitudinal associations between biomarkers of inflammation and changes in depressive symptoms in patients with type 1 and type 2 diabetes. Psychoneuroendocrinology. 2018 May — View Citation

Schmitt A, Kulzer B, Ehrmann D, Haak T, Hermanns N. Diabetes Distress and Depression during COVID-19: Response to Breznoscakova et al. Uncovering the Untold Emotional Toll of Living with Diabetes in the COVID-19 Era. Psychother Psychosom. 2022;91(4):288-289. doi: 10.1159/000524602. Epub 2022 May 6. — View Citation

Schmitt A, Kulzer B, Reimer A, Herder C, Roden M, Haak T, Hermanns N. Evaluation of a Stepped Care Approach to Manage Depression and Diabetes Distress in Patients with Type 1 Diabetes and Type 2 Diabetes: Results of a Randomized Controlled Trial (ECCE HOM — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Inflammatory Markers 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
Other Major Depressive Disorder Difference in rates of major depression according to ICD-10 criteria between baseline and 12 months follow up 12 months
Primary Depressive Mood - Hamilton Rating Scale for Depression (HAMD) Mean difference between HAMD scores at baseline and at 12 month follow up 12 month
Secondary Diabetes-Related Distress - The Problem Areas in Diabetes Questionnaire (PAID) Mean difference between PAID scores at baseline and at 12 month follow up 12 months
Secondary Psychological/ Emotional Well-Being - The WHO-5 Well-being Index (WHO-5) Mean difference between WHO-5 scores at baseline and at 12 month follow up 12 month
Secondary Health-Related Quality of Life - The Short Form-36 Health Survey (SF-36) Mean difference between SF-36 scores at baseline and at 12 month follow up 12 month
Secondary Diabetes Self-Care Behavior - The Summary of Diabetes Self-Care Activities Measure (SDSCA) Mean differences between SDSCA scores at baseline and at 12 month follow 12 month
Secondary Glycaemic Control (HbA1c) Mean differences between HbA1c values at baseline and at 12 month follow 12 month
Secondary Health-Related Quality of Life - The EuroQol-5D (EQ-5D) Mean differences between EQ-5D scores at baseline and at 12 month follow 12 month
Secondary Diabetes Self-Care Behavior - The Diabetes Self-Management Questionnaire (DSMQ) Mean differences between DSMQ scores at baseline and at 12 month follow 12 month
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