Type 2 diabetes, minor or mild major depression Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
This is a three-arm trial, randomisation on individual basis (i.e. not cluster randomisation).
Cogntive Behavioral Therapy is based on a manualised programme (12 weekly sessions) designed for older a
Sponsors
Ruhr University of Bochum (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diabetes mellitus type 2 diagnosed at least 6 months before entering the trial 2. Both males and females, 65 to 85 years of age 3. Minor depression (adapted from the Diagnostic and statistical manual of mental disorders [4th edition, text revision] [DSM-IV-TR] research criteria: we require 3-4 symptoms rather than 2-4 symptoms and a past history of major depression is not an exclusion criteria), or mild major depression (according to DSM-IV-TR criteria 5 to 6 depressive symptoms) 4. Living near the coordination institution where treatment will take place 5. Signed written informed consent
Exclusion criteria
Exclusion criteria: 1. Serious violent, homicidal, or suicidal ideation; particularly clinically significant suicide risk or history of attempted suicide within the past 2 years 2. History of schizophrenia, psychotic symptoms or bipolar disorder 3. Organic brain syndrome, dementia or substantial cognitive impairment 4. Alcohol or substance abuse or dependence in the past 12 months (other than nicotine abuse/dependence) 5. Insufficient ability to understand German 6. Regular participation in a self-help-group (minimum 4 sessions in the last 12 months) 7. Psychotherapy (in the past 3 months) 8. Bereavement and grief reaction (loss <3 months) 9. Planned hospital admission next 3 months 10. Medical contraindication for physical activity 11. History of severe acute or chronic medical disorder (other than diabetes) ? which would probably impair trial commitment or lead to biased trial results (based on the critical ap-praisal of the investigator) 12. Patients who have taken antidepressants or mood stabilizing medication regularly over the 30 days prior to screening, patients who have taken fluoxetine regularly over the 60 days prior to screening, or patients on depot neuroleptic medication over the 5 inter-injection intervals prior to screening 13. History of severe acute or chronic medical disorder (other than diabetes) ? in the opinion of the investigator - preventing trial commitment or confounding interpretation of trial results 14. Blood chemistries alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) value(s) greater than or equal to three times the upper limit of normal prior to randomisation; estimated glomerular filtration rate (GFR) lower than 30; blood chemis-tries thyroid-stimulating hormone (TSH) values lower than 0.5 mU/l or greater than 5 mUl adapted to reference ranges of the laboratory 15. Legal incompetence or legal guardianship 16. Participation in competing trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mental Component Summary z-transformed score of the SF-36® Health Survey (generic HRQoL) assessed at the one year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at one year follow-up: 1. HRQoL (Physical Component Summary z-transformed score of the SF-36® Health Survey) 2. Reduction of depressive symptoms (Quick Inventory of Depressive Symptoms?Clinician Rated [QIDS-C-16]) 3. Prevention of moderate/severe major depression (Depression module, Structured Clinical Interview for DSM-IV [SCID]) 4. Improvement of glycaemic control (HbA1c) 5. Mortality (yearly follow-up evaluations with mortality as an additional endpoint are planned depending on subsequent funding) 6. Cost effectiveness (direct treatment costs: medication, hospitalisation and other costs over a period of one year) | — |
Countries
Germany
Outcome results
None listed