N/A
Completed N=214
Evaluation of a Diabetes-specific Cognitive Behavioural Treatment for Subthreshold Depression
Source: ClinicalTrials.gov NCT01009138 ↗Enrolled (actual)
214
Serious AEs
15.0%
Results posted
Nov 2015
Primary outcomePrimary: Depressive Symptoms (CES-D Score) — -7.4; -2.7 Scores on a scale
Summary
This work is supported by the "Kompetenznetz Diabetes mellitus (Competence Network for Diabetes mellitus)" funded by the Federal Ministry of Education and Research (FKZ 01GI0809).
Approximately one third of diabetic patients has elevated depressive symptoms. The majority of these patients are suffering from a subthreshold depression. In spite of the fact that subthreshold depression has an equivalent negative impact on the prognosis of diabetes as clinical depression, there is no specific intervention tool. The main objective of this project is to develop a diabetes specific cognitive behavioural treatment (DS-CBT) for diabetic patients with subthreshold depression. In a randomized trail DS-CBT is compared to standard diabetes education. A total of 188 diabetic patients will be recruited and randomly assigned to the two treatment conditions. The expected main outcome is the reduction of subthreshold depression under DS-CBT in a 12 month follow up. Secondary variables are improvement of glycaemic control, quality of life, diabetes self-management as well as reduction of health care costs and modification of inflammatory parameters.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Symptoms (CES-D Score) |
-7.4; -2.7 | — |
| SECONDARY Quality of Life (EQ-5D TTO Score) |
-0.01; -0.01 | — |
| SECONDARY Diabetes-specific Distress (PAID Score) |
-13.0; -4.2 | — |
| SECONDARY Diabetes Self-Care (SDSCA Score) |
-0.1; 0.0 | — |
| SECONDARY Diabetes Acceptance (AADQ Score) |
2.5; 2.0 | — |
| SECONDARY Glycemic Control (HbA1c) |
-0.5; -0.7 | — |
| SECONDARY Inflammatory Marker IL-6 |
0.0; 0.1 | — |
| SECONDARY Inflammatory Marker IL-1Ra |
-100.5; -70.8 | — |
| SECONDARY Inflammatory Marker Hs-CRP |
0.0; 0.0 | — |
| SECONDARY Health-care Costs: Health-care Utilisation |
-2.2; -1.4 | — |
| SECONDARY Health-care Costs: Non-productive Time |
-2.2; 5.8 | — |
| SECONDARY Health-care Costs: Medication Intake |
0.7; 0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Diabetes mellitus
- Elevated depressive symptoms (regarding to CES-D)
- Age >= 18 and <=70
- Sufficient German language skills
- Informed consent
Exclusion Criteria
- Current MDD
- Current schizophrenia/ psychotic disorder, eating disorder, bipolar disorder, addictive disorder, personality disorder
- Current antidepressive medication
- Current psychotherapy
- Severe physical illness (i.e. cancer)
- Being bedridden
- Guardianship
Data sourced from ClinicalTrials.gov (NCT01009138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.