Type 1 or type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
Please note that as of 08/05/2008 the anticipated end date of this trial was extended. The previous anticipated end date of this trial was 31/01/2009.
1. Ten sessions (20 hours) of diabetes-specific
Sponsors
Ruhr University of Bochum (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 08/05/2008: 1. Type 1 or type 2 diabetes mellitus diagnosed at least 12 months beforehand 2. Insulin treatment for at least the past six months 3. 21 to 69 years of age 4. Poor glycaemic control (HbA1c level greater than 7.5% measured twice within the preceding nine months) 5. Current major depression - Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV-TR) criteria Previous inclusion criteria: 1. Type 1 or type 2 diabetes mellitus diagnosed at least 12 months beforehand 2. Insulin treatment for at least the past six months 3. 21 to 65 years of age 4. Poor glycaemic control (HbA1c level >8% measured twice within the preceding nine months) 5. Current major depression - Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV-TR) criteria
Exclusion criteria
Exclusion criteria: 1. Clinically significant suicide risk or history of attempted suicide 2. History of schizophrenia or psychotic symptoms 3. Bipolar disorder 4. Organic brain syndrome or dementia 5. Alcohol or substance abuse or dependence in the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current information as of 11/11/2010 due to the amendment of 12/11/2008: Change of glycaemic control (difference in HbA1c value from baseline to the end of the long term phase). Initial information at time of registration: Improvement of glycaemic control (minimum 1% decrease in glycosylated haemoglobin A1c test [HbA1c value]) from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current information as of 11/11/2010 due to the amendment of 12/11/2008: 1. "Improvement of glycaemic control" defined as a decrease of at least 1% in HbA1c value from baseline to the end of the long-term phase 2. Remission of depression, not fulfilling the DSM-IV-TR criteria for depression according to the Structured Clinical Interview Diagnosis (SCID) and depression score Hamilton Rating Scale (HAMD) Interview less than or equal to 7 3. Improvement of depression, i.e. a reduction of the HAMD-score from baseline to the end of study by at least 50% 4. Change from baseline to end of study in generic HRQoL as assessed per SF-36 5. Change from baseline to end of study regarding problems in daily living with diabetes as assessed per PAID Initial information at time of registration: 1. Remission of depression: no longer fulfilling the DSM-IV-TR criteria for depression according to the Structured Clinical Interview Diagnosis (SCID), and depression score on the Hamilton Depression Rating Scale (HAMD) Interview less than or equal to 7 2. Improvement of depression (greater than or equal to 50% reduction on the HAMD-baseline score) 3. Improved generic Health-Related Quality of Life (HRQoL), per SF-3 4. Decreased problems in daily living with diabetes, per Problem Areas In Diabetes scale (PAID) | — |
Countries
Germany
Outcome results
None listed