Status:
COMPLETED
Evaluation of a Stepped Care Approach to Manage Depression in Diabetes
Lead Sponsor:
Forschungsinstitut der Diabetes Akademie Mergentheim
Collaborating Sponsors:
German Federal Ministry of Education and Research
German Diabetes Center
Conditions:
Major Depressive Disorder
Minor Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT01812291
Start Date
February 1 2012
End Date
November 1 2015
Last Update
September 14 2022
Active Locations (1)
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1
Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
Bad Mergentheim, Baden-Wurttemberg, Germany, D-97980