Efficacy of a Stepped Care Approach to Manage Depression in Diabetic Patients and Putative Inflammatory Mechanisms Between Diabetes and Depressio
Not Applicable
- Conditions
- Major Depressive DisorderMinor Depressive DisorderSub-Threshold DepressionDiabetes MellitusF33.9E14Recurrent depressive disorder, unspecifiedUnspecified diabetes mellitus
- Registration Number
- DRKS00010862
- Lead Sponsor
- Forschungsinstitut der Diabetes Akademie Bad Mergentheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 260
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 & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - 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<br>
- Secondary Outcome Measures
Name Time Method