Clinical trial NCT01812291: Evaluation of a Stepped Care Approach to Manage Depression in Diabetes
Official title: Efficacy of a Stepped Care Approach to Manage Depression in Diabetic Patients and Putative Inflammatory Mechanisms Between Diabetes and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Minor Depressive Disorder
Sub-Threshold Depression
Diabetes Mellitus
Keywords: Major Depression
Minor Depression
Sub-Threshold Depression
Affective Condition
Mood Disorder
Light Affective Disorder
Subclinical Depressive Symptoms
Diabetes Mellitus
Diabetes-Related Distress
Self-Care Behaviour
Glycaemic Control
Inflammatory Markers
Lead sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: German Diabetes Center
name: Heinrich-Heine University, Duesseldorf
name: University of Giessen
name: Helmholtz Zentrum München
name: Coordination Center for Clinical Trials (KKS)
First posted: 2013-03-18
Enrollment: 260
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: The study examines the efficacy of a stepped care approach for depressed diabetes patients (first study objective). 256 patients with diabetes and comorbid subthreshold or clinical depression will be randomly assigned to either a stepped care approach or a treatment-as-usual condition. The stepped care approach consists of three treatment steps comprising diabetes-specific cognitive-behavioral therapy (CBT) (group), depression-specific CBT (single), and psychotherapeutic and/or psychiatric treatment (single). Patients assigned to the stepped care approach will be treated stepwise until a clinically significant reduction of depressive symptoms is attained or all three treatment steps are passed.

The primary outcome of the first study objective is a clinically significant reduction of depressive symptoms in the 12-month follow-up. Secondary outcomes are reduction of diabetes-related distress and improvement of well-being, health-related quality of life, diabetes acceptance, diabetes self-care, and glycaemic control. Additionally, cost-benefit analyses will be performed.

The second study objective is to analyse associations between diabetes, depression, and the serum levels of inflammatory markers.

The third study objective is to analyse the courses of depressive conditions in diabetes with regard to recovery rates and incidence of major depression.

Detailed description: Compared to persons without diabetes, rates of depressive disorders and mood are doubled in diabetes patients. Epidemiologic studies have shown point prevalence rates of 10 - 14% for major depressive disorder and an additional proportion of almost 20% with subthreshold depression (defined as elevated depressive symptoms without meeting criteria for a specified clinical disorder). Depression and subthreshold depression in diabetes are associated with reduced quality of life, increased diabetes-related distress, and elevated health care costs. Furthermore, depression as well as subthreshold depression seem to be major barriers to an effective self-management of the disease and have been associated with reduced glycaemic control and hyperglycaemia. Both conditions seem to be independent prognostic factors for subsequent morbidity and mortality in diabetes.

Depressive conditions are commonly treated with psychotherapeutic or pharmacologic antidepressive therapies. Since the majority of diabetes patients is suffering from subthreshold depression, evaluated and suitable specific intervention concepts are rare. Moreover, the large variation of symptom levels of depressive patient groups suggests that different types of treatment with different treatment intensities may be required to match individual demands. The issue of 'optimal' treatment also regards concerns about overtreatment and undertreatment of particular patient groups with depressive conditions. Thus, an successive order of treatment steps of increasing intensity appears useful. Since depression in diabetes often is associated with high diabetes-related problems and distress, diabetes-specific as well as depression-specific interventions may be required.

We developed a stepped care approach with three treatment steps comprising diabetes-specific CBT (group), depression-specific CBT (single), and psychotherapeutic and/or psychiatric treatment (single).

The study is a randomized efficacy trial in which the efficacy of the stepped care approach is compared to a treatment-as-usual condition (standard diabetes education). 256 patients with diabetes and comorbid subthreshold or clinical depression will be randomly assigned to either the stepped care approach or the treatment-as-usual condition. Patients assigned to the stepped care approach will be treated stepwise until a clinically significant reduction of depressive symptoms is attained or all three treatment steps are passed.

The primary outcome is a clinically significant reduction of depressive symptoms in the 12-month follow-up. Secondary outcomes are reduction of diabetes-related distress and improvement of well-being, health-related quality of life, diabetes acceptance, diabetes self-care, and glycaemic control. The decisive measurement of this outcomes are conducted 12 months after the treatment (12 month follow up). Additionally, cost-benefit analyses will be performed.

Besides testing the efficacy of the stepped care approach (first objective), there are two additional study objectives:

The second study objective is to analyse associations between diabetes, depression, and the serum levels of inflammatory markers (C-reactive protein (CRP), Interleukin (IL)-6, IL-18, IL-1Ra, Adiponectin, Monocyte chemoattractant protein (MCP)-1). Additionally, the impact of depression treatment on the levels of these markers will be examined.

The third study objective is to analyse the courses of depressive conditions in diabetes with regard to recovery rates and incidence of major depression in subclinically or clinically depressed diabetes patients treated as usual vs. given an intervention.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive Mood - Hamilton Rating Scale for Depression (HAMD)
timeFrame: 12 month
Secondary outcomes:
measure: Diabetes-Related Distress - The Problem Areas in Diabetes Questionnaire (PAID)
timeFrame: 12 months
measure: Psychological/ Emotional Well-Being - The WHO-5 Well-being Index (WHO-5)
timeFrame: 12 month
measure: Health-Related Quality of Life - The Short Form-36 Health Survey (SF-36)
timeFrame: 12 month
measure: Diabetes Self-Care Behavior - The Summary of Diabetes Self-Care Activities Measure (SDSCA)
timeFrame: 12 month
measure: Glycaemic Control (HbA1c)
timeFrame: 12 month
measure: Health-Related Quality of Life - The EuroQol-5D (EQ-5D)
timeFrame: 12 month
measure: Diabetes Self-Care Behavior - The Diabetes Self-Management Questionnaire (DSMQ)
timeFrame: 12 month
Other outcomes:
measure: Inflammatory Markers
timeFrame: Baseline, 12 month follow up
measure: Major Depressive Disorder
timeFrame: 12 months
Locations:
city: Bad Mergentheim
country: Germany
facility: Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
state: Baden-Wuerttemberg
Study officials:
affiliation: Forschungsinstitut der Diabetes Akademie Mergentheim
name: Bernhard Kulzer, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Forschungsinstitut der Diabetes Akademie Mergentheim
name: Norbert Hermanns, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Forschungsinstitut der Diabetes Akademie Mergentheim
name: Thomas Haak, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University of Giessen
name: Johannes Kruse, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmitt A, Kulzer B, Ehrmann D, Haak T, Hermanns N. Diabetes Distress and Depression during COVID-19: Response to Breznoscakova et al. Uncovering the Untold Emotional Toll of Living with Diabetes in the COVID-19 Era. Psychother Psychosom. 2022;91(4):288-289. doi: 10.1159/000524602. Epub 2022 May 6. No abstract available.
citation: Schmitt A, Kulzer B, Reimer A, Herder C, Roden M, Haak T, Hermanns N. Evaluation of a Stepped Care Approach to Manage Depression and Diabetes Distress in Patients with Type 1 Diabetes and Type 2 Diabetes: Results of a Randomized Controlled Trial (ECCE HOMO Study). Psychother Psychosom. 2022;91(2):107-122. doi: 10.1159/000520319. Epub 2021 Dec 7.
citation: Herder C, Schmitt A, Budden F, Reimer A, Kulzer B, Roden M, Haak T, Hermanns N. Association between pro- and anti-inflammatory cytokines and depressive symptoms in patients with diabetes-potential differences by diabetes type and depression scores. Transl Psychiatry. 2018 Mar 9;7(11):1. doi: 10.1038/s41398-017-0009-2.
citation: Herder C, Schmitt A, Budden F, Reimer A, Kulzer B, Roden M, Haak T, Hermanns N. Longitudinal associations between biomarkers of inflammation and changes in depressive symptoms in patients with type 1 and type 2 diabetes. Psychoneuroendocrinology. 2018 May;91:216-225. doi: 10.1016/j.psyneuen.2018.02.032. Epub 2018 Mar 6.
citation: Schmitt A, Reimer A, Kulzer B, Haak T, Gahr A, Hermanns N. Assessment of diabetes acceptance can help identify patients with ineffective diabetes self-care and poor diabetes control. Diabet Med. 2014 Nov;31(11):1446-51. doi: 10.1111/dme.12553. Epub 2014 Aug 2.