Major Depressive DisorderEcce_homoNCT01812291
Evaluation of a Stepped Care Approach to Manage Depression in Diabetes
A study testing Step 1: Diabetes-Specific CBT (5 group sessions), Step 2: Depression-Specific CBT (6 single sessions) and Step 3: Referral to Psychotherapist and/or Psychiatrist in people with Major Depressive Disorder and Minor Depressive Disorder, run by Forschungsinstitut der Diabetes Akademie Mergentheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder, Minor Depressive Disorder, Sub-Threshold Depression
- What is being tested?
- Step 1: Diabetes-Specific CBT (5 group sessions), Step 2: Depression-Specific CBT (6 single sessions) and Step 3: Referral to Psychotherapist and/or Psychiatrist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Terminal illness
- Bedriddenness
- Guardianship
Trial locations and contacts
1 site in 1 country.
Germany1 site
Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
Bad Mergentheim, Baden-Wurttemberg, D-97980
About this study
Official title: Efficacy of a Stepped Care Approach to Manage Depression in Diabetic Patients and Putative Inflammatory Mechanisms Between Diabetes and Depression
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.
Read more
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Minor Depressive Disorder, Sub-Threshold Depression, Diabetes Mellitus
- Being tested
- Step 1: Diabetes-Specific CBT (5 group sessions), Step 2: Depression-Specific CBT (6 single sessions), Step 3: Referral to Psychotherapist and/or Psychiatrist, Standard Diabetes Education
- 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
- Medical subject headings
- Depressive Disorder, Major, Diabetes Mellitus, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step 1: Diabetes-Specific CBT (5 group sessions)Behavioural
Diabetes-Specific CBT (5 group sessions) focusing on diabetes-related problems and distress ('DIAMOS - Strengthening Diabetes Motivation').
Includes:
- Diabetes problem analysis/ definition
- Diabetes problem solving intervention
- Cognitive restructuring of diabetes problems
- Activation of personal and social resources
- Goal definition and agreement
Step 2: Depression-Specific CBT (6 single sessions)Behavioural
Depression-Specific CBT (6 single sessions) focusing on depressive cognitions and affective problems (manualised).
Includes:
- Functional explanatory model of depression
- Cognitive restructuring of negative thoughts
- Practice of alternative beneficial thoughts
- Specific cognitive interventions regarding self-criticism, guilt, low self-esteem, fear, and inactivity.
Step 3: Referral to Psychotherapist and/or PsychiatristBehavioural
Non-responders to previous treatment steps will be referred to an psychotherapist and/or psychiatrist for intensified treatment. Treatments procedures will be monitored and interventions will be scored to enable the evaluation of treatment effects.
Standard Diabetes EducationBehavioural
Standard diabetes education and professional care.
Includes:
- Health care and specific topics (e. g. blood pressure)
- Diabetes complications
- Healthy and unhealthy foods, cooking recommendations and recipes
- Foot care: exercises, care and control, injuries, and diabetic neuropathy
- Sports, activities and exercise
- Social aspects of living with diabetes
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care Approach for Depression | Experimental | Step 1: Diabetes-Specific CBT (5 group sessions)
Step 2: Depression-Specific CBT (6 single sessions)
Step 3: Referral to Psychotherapist and/or Psychiatrist Receives: Behavioral: Step 1: Diabetes-Specific CBT (5 group sessions); Behavioral: Step 2: Depression-Specific CBT (6 single sessions); Behavioral: Step 3: Referral to Psychotherapist and/or Psychiatrist |
| Treatment-as-usual | Active comparator | Standard Diabetes Education Receives: Behavioral: Standard Diabetes Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Mood - Hamilton Rating Scale for Depression (HAMD)
Mean difference between HAMD scores at baseline and at 12 month follow up
Measured: 12 month
Secondary outcomes (7)
Diabetes-Related Distress - The Problem Areas in Diabetes Questionnaire (PAID)
Mean difference between PAID scores at baseline and at 12 month follow up
Measured: 12 months
Psychological/ Emotional Well-Being - The WHO-5 Well-being Index (WHO-5)
Mean difference between WHO-5 scores at baseline and at 12 month follow up
Measured: 12 month
Health-Related Quality of Life - The Short Form-36 Health Survey (SF-36)
Mean difference between SF-36 scores at baseline and at 12 month follow up
Measured: 12 month
Diabetes Self-Care Behavior - The Summary of Diabetes Self-Care Activities Measure (SDSCA)
Mean differences between SDSCA scores at baseline and at 12 month follow
Measured: 12 month
Glycaemic Control (HbA1c)
Mean differences between HbA1c values at baseline and at 12 month follow
Measured: 12 month
Health-Related Quality of Life - The EuroQol-5D (EQ-5D)
Mean differences between EQ-5D scores at baseline and at 12 month follow
Measured: 12 month
Diabetes Self-Care Behavior - The Diabetes Self-Management Questionnaire (DSMQ)
Mean differences between DSMQ scores at baseline and at 12 month follow
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startFeb 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forschungsinstitut der Diabetes Akademie Mergentheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, German Diabetes Center, Heinrich-Heine University, Duesseldorf, University of Giessen, Helmholtz Zentrum München
- Responsible party
- Principal investigator, Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
- Investigators
- Bernhard Kulzer, PD Dr., Principal investigator, Forschungsinstitut der Diabetes Akademie MergentheimNorbert Hermanns, Prof. Dr., Principal investigator, Forschungsinstitut der Diabetes Akademie MergentheimThomas Haak, Prof. Dr., Study director, Forschungsinstitut der Diabetes Akademie MergentheimJohannes Kruse, Prof. Dr., Principal investigator, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812291
- Sponsor's protocol ID
- FKZ 01GI1107
- Acronym
- Ecce_homo
- Status last verified
- Sep 2022
- First submitted
- 14 Mar 2013
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35526518Schmitt 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.
PubMed 34875666Herder 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.
PubMed 29520075Herder 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.
PubMed 29525039Schmitt 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.
PubMed 25047992
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Stepped Care Approach to Manage Depression in Diabetic Patients and Putative Inflammatory Mechanisms Between Diabetes and Depression
- ClinicalTrials.gov ID
- NCT01812291
- Acronym / sponsor ID
- Ecce_homo / FKZ 01GI1107
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Forschungsinstitut der Diabetes Akademie MergentheimUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, German Diabetes Center, Heinrich-Heine University, Duesseldorf, University of Giessen, Helmholtz Zentrum München
- Study start
- Feb 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Care Approach for Depression | Experimental | Behavioral: Step 1: Diabetes-Specific CBT (5 group sessions), Behavioral: Step 2: Depression-Specific CBT (6 single sessions), Behavioral: Step 3: Referral to Psychotherapist and/or PsychiatristStep 1: Diabetes-Specific CBT (5 group sessions) Step 2: Depression-Specific CBT (6 single sessions) Step 3: Referral to Psychotherapist and/or Psychiatrist |
| Treatment-as-usual | Active comparator | Behavioral: Standard Diabetes EducationStandard Diabetes Education |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step 1: Diabetes-Specific CBT (5 group sessions)Diabetes-Specific CBT (5 group sessions) focusing on diabetes-related problems and distress ('DIAMOS - Strengthening Diabetes Motivation'). Includes: * Diabetes problem analysis/ definition * Diabetes problem solving intervention * Cognitive restructuring of diabetes problems * Activation of personal and social resources * Goal definition and agreement | Behavioural | Stepped Care Approach for Depression |
| Step 2: Depression-Specific CBT (6 single sessions)Depression-Specific CBT (6 single sessions) focusing on depressive cognitions and affective problems (manualised). Includes: * Functional explanatory model of depression * Cognitive restructuring of negative thoughts * Practice of alternative beneficial thoughts * Specific cognitive interventions regarding self-criticism, guilt, low self-esteem, fear, and inactivity. | Behavioural | Stepped Care Approach for Depression |
| Step 3: Referral to Psychotherapist and/or PsychiatristNon-responders to previous treatment steps will be referred to an psychotherapist and/or psychiatrist for intensified treatment. Treatments procedures will be monitored and interventions will be scored to enable the evaluation of treatment effects. | Behavioural | Stepped Care Approach for Depression |
| Standard Diabetes EducationStandard diabetes education and professional care. Includes: * Health care and specific topics (e. g. blood pressure) * Diabetes complications * Healthy and unhealthy foods, cooking recommendations and recipes * Foot care: exercises, care and control, injuries, and diabetic neuropathy * Sports, activities and exercise * Social aspects of living with diabetes | Behavioural | Treatment-as-usual |
Primary outcome
Depressive Mood - Hamilton Rating Scale for Depression (HAMD)
Time frame: 12 month
Mean difference between HAMD scores at baseline and at 12 month follow up
7 secondary outcomes
Diabetes-Related Distress - The Problem Areas in Diabetes Questionnaire (PAID)
Time frame: 12 months
Psychological/ Emotional Well-Being - The WHO-5 Well-being Index (WHO-5)
Time frame: 12 month
Health-Related Quality of Life - The Short Form-36 Health Survey (SF-36)
Time frame: 12 month
Diabetes Self-Care Behavior - The Summary of Diabetes Self-Care Activities Measure (SDSCA)
Time frame: 12 month
Glycaemic Control (HbA1c)
Time frame: 12 month
Health-Related Quality of Life - The EuroQol-5D (EQ-5D)
Time frame: 12 month
Diabetes Self-Care Behavior - The Diabetes Self-Management Questionnaire (DSMQ)
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 35526518Schmitt 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.
- Results publication: PubMed 34875666Schmitt 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.
- Results publication: PubMed 29520075Herder 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.
- Results publication: PubMed 29525039Herder 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.
- Derived from this study: PubMed 25047992Schmitt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Kulzer, PD Dr. principal investigator
Forschungsinstitut der Diabetes Akademie Mergentheim
Norbert Hermanns, Prof. Dr. principal investigator
Forschungsinstitut der Diabetes Akademie Mergentheim
Thomas Haak, Prof. Dr. study director
Forschungsinstitut der Diabetes Akademie Mergentheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step 1: Diabetes-Specific CBT (5 group sessions), Step 2: Depression-Specific CBT (6 single sessions) and Step 3: Referral to Psychotherapist and/or Psychiatrist in people with Major Depressive Disorder and Minor Depressive Disorder, run by Forschungsinstitut der Diabetes Akademie Mergentheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Mood - Hamilton Rating Scale for Depression (HAMD) (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01812291, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.