Clinical trial NCT01009138: Evaluation of a Diabetes-specific Cognitive Behavioural Treatment for Subthreshold Depression
Official title: Development and Evaluation of a Diabetes-specific Cognitive Behavioural Treatment (DS-CBT) for Diabetic Patients With Subthreshold Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Diabetes Mellitus
Keywords: Subthreshold Depression
Diabetes-related Distress
Minor Depression
Light affective Disorder
Subclinical depressive Symptoms
Diabetes mellitus
Late Complications
Markers of Inflammation
Lead sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor class: OTHER
Collaborators: name: German Diabetes Center
name: University of Giessen
name: Heinrich-Heine University, Duesseldorf
First posted: 2009-11-06
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Elevated rates for depression in diabetic patients are of clinical significance for diabetology. Depressive disorders are doubled compared to patients without diabetes. A meta-analysis showed that a proportion of 20% of diabetic patients showed subthreshold depression, defined as elevated depressive symptoms without meeting criteria for clinical depression. Depression in diabetes is associated with a reduced quality of life, more diabetes related distress, and higher health related costs. But besides this, depression in diabetes seems to be an independent negative prognostic factor for morbidity and mortality. Furthermore subthreshold depression is a major barrier of an effective self-management of the disease.

Until now antidepressive therapies are only evaluated in clinically depressed diabetic patients. For the majority of depressed diabetic patients suffering from subthreshold depression no evaluated specific intervention concept exists. Since subthreshold depression often is associated with diabetes related distress a diabetes specific intervention was developed to support patients to increase their problem solving skills, modify their depressive cognitions and improve their coping with diabetes related distress. It consists of five sessions and is delivered as a group intervention.

This study is an efficacy trial. In this randomized trial the efficacy of this newly developed intervention is compared to a control condition consisting of five standard diabetes education lessons. The primary outcome variable is the reduction of depressive symptoms twelve months after the intervention. Secondary outcome variables are the quality of life, metabolic parameters, self-care behavior and other psychosocial aspects. Furthermore the possible covariation between change of depressive symptoms and inflammatory and immune markers will be analyzed.

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

Primary outcomes:
measure: Depressive Symptoms (CES-D Score)
timeFrame: Baseline, 12 month FU
Secondary outcomes:
measure: Quality of Life (EQ-5D TTO Score)
timeFrame: Baseline,12 month FU
measure: Diabetes-specific Distress (PAID Score)
timeFrame: Baseline, 12 month FU
measure: Diabetes Self-Care (SDSCA Score)
timeFrame: Baseline, 12 month FU
measure: Diabetes Acceptance (AADQ Score)
timeFrame: Baseline, 12 month FU
measure: Glycemic Control (HbA1c)
timeFrame: Baseline, 12 month FU
measure: Inflammatory Marker IL-6
timeFrame: Baseline, 12 month FU
measure: Inflammatory Marker IL-1Ra
timeFrame: Baseline, 12 month FU
measure: Inflammatory Marker Hs-CRP
timeFrame: Baseline, 12 month FU
measure: Health-care Costs: Health-care Utilisation
timeFrame: Baseline, 12 months-FU
measure: Health-care Costs: Non-productive Time
timeFrame: Baseline, 12 months-FU
measure: Health-care Costs: Medication Intake
timeFrame: Baseline, 12 months-FU
Other outcomes:
Locations:
city: Bad Mergentheim
country: Germany
facility: Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
state: Baden-Württemberg
Study officials:
affiliation: Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
name: Bernhard Kulzer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
name: Norbert Hermanns, Prof., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetes Zentrum Mergentheim; Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
name: Thomas J Haak, Prof., MD
role: STUDY_DIRECTOR
References:
citation: Tulu S, Telci Caklili O, Alkaya G, Oguz A. Comment on Hermanns et al. The Effect of a Diabetes-Specific Cognitive Behavioral Treatment Program (DIAMOS) for Patients With Diabetes and Subclinical Depression: Results of a Randomized Controlled Trial. Diabetes Care 2015;38:551-560. Diabetes Care. 2016 Jan;39(1):e12. doi: 10.2337/dc15-1692. No abstract available.
citation: Hermanns N, Schmitt A, Reimer A, Ehrmann D, Haak T, Kulzer B. Response to Comment on Hermanns et al. The Effect of a Diabetes-Specific Cognitive Behavioral Treatment Program (DIAMOS) for Patients With Diabetes and Subclinical Depression: Results of a Randomized Controlled Trial. Diabetes Care 2015;38:551-560. Diabetes Care. 2016 Jan;39(1):e13-4. doi: 10.2337/dci15-0017. No abstract available.
citation: Hermanns N, Schmitt A, Gahr A, Herder C, Nowotny B, Roden M, Ohmann C, Kruse J, Haak T, Kulzer B. The effect of a Diabetes-Specific Cognitive Behavioral Treatment Program (DIAMOS) for patients with diabetes and subclinical depression: results of a randomized controlled trial. Diabetes Care. 2015 Apr;38(4):551-60. doi: 10.2337/dc14-1416. Epub 2015 Jan 20.
citation: Reimer A, Schmitt A, Ehrmann D, Kulzer B, Hermanns N. Reduction of diabetes-related distress predicts improved depressive symptoms: A secondary analysis of the DIAMOS study. PLoS One. 2017 Jul 10;12(7):e0181218. doi: 10.1371/journal.pone.0181218. eCollection 2017.
citation: Schmitt A, Reimer A, Ehrmann D, Kulzer B, Haak T, Hermanns N. Reduction of depressive symptoms predicts improved glycaemic control: Secondary results from the DIAMOS study. J Diabetes Complications. 2017 Nov;31(11):1608-1613. doi: 10.1016/j.jdiacomp.2017.08.004. Epub 2017 Aug 9.
citation: Chernyak N, Kulzer B, Hermanns N, Schmitt A, Gahr A, Haak T, Kruse J, Ohmann C, Scheer M, Giani G, Icks A. Within-trial economic evaluation of diabetes-specific cognitive behaviour therapy in patients with type 2 diabetes and subthreshold depression. BMC Public Health. 2010 Oct 19;10:625. doi: 10.1186/1471-2458-10-625.