Depressive SymptomsNCT01009138
Evaluation of a Diabetes-specific Cognitive Behavioural Treatment for Subthreshold Depression
A study testing Diabetes-Specific CBT (DS-CBT) and Standard Diabetes Education in people with Depressive Symptoms and Diabetes Mellitus, run by Forschungsinstitut der Diabetes Akademie Mergentheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Symptoms, Diabetes Mellitus
- What is being tested?
- Diabetes-Specific CBT (DS-CBT) and Standard Diabetes Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diabetes mellitus
- Elevated depressive symptoms (regarding to CES-D)
- Age >= 18 and <=70
- Sufficient German language skills
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
Bad Mergentheim, Baden-Wurttemberg, 97980
About this study
Official title: Development and Evaluation of a Diabetes-specific Cognitive Behavioural Treatment (DS-CBT) for Diabetic Patients With Subthreshold Depression
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.
Read the 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.
- Conditions
- Depressive Symptoms, Diabetes Mellitus
- Being tested
- Diabetes-Specific CBT (DS-CBT), Standard Diabetes Education
- Keywords
- Subthreshold Depression, Diabetes-related Distress, Minor Depression, Light affective Disorder, Subclinical depressive Symptoms, Diabetes mellitus, Late Complications, Markers of Inflammation
- Medical subject headings
- Depression, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes-Specific CBT (DS-CBT)Behavioural
Also called Diabetes-Specific Cognitive-Behavioral Group Sessions
5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:
- Problem Analysis and Definition
- Problem Solving Intervention
- Cognitive Restructuring
- Activation of personal and social Resources
- Goal Definition and Agreement
Standard Diabetes EducationBehavioural
Also called Educative Group Lesson and Discussion
Standard Diabetes Education Lesson including
- Health Care and specific Topics (e. g. Blood Pressure)
- Social Aspects of Living with Diabetes
- Diabetes Complications
- Sports, Activities and Exercise
- Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes
- Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy
| Study group | Role | What they receive |
|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Experimental | Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems Receives: Behavioral: Diabetes-Specific CBT (DS-CBT) |
| Standard Diabetes Education | Active comparator | Standard Diabetes Education Lessons will be given to quantify the unspecific antidepressive Effects of Participation in Group Sessions with social Contact and Acquisition of Knowledge. Receives: Behavioral: Standard Diabetes Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms (CES-D Score)
The Center for Epidemiologic Studies Depression Scale (CES-D) was used to assess depressive symptoms. The CES-D assesses the frequency of 20 typical symptoms of depression during the previous week on a 4-point Likert scale. Summing of the item scores estimates the total score with a range between 0 and 60 and higher scores indicating more severe depressive mood. Based on the measurement of depressive symptoms at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.
Measured: Baseline, 12 month FU
Secondary outcomes (11)
Quality of Life (EQ-5D TTO Score)
The EuroQol Five Dimension Questionnaire (EQ-5D) was used to assess health-related quality of life (HRQOL). The EQ-5D assesses five dimensions of HRQOL using a 3-point scale. The item scores are weighted based on population data and used to calculate a standardised total score from 0 to 1 with higher scores indicating better HRQOL. Based on the measurement of HRQOL at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.
Measured: Baseline,12 month FU
Diabetes-specific Distress (PAID Score)
The Problem areas in Diabetes Scale (PAID) was used to assess diabetes-specific distress. The PAID assesses diabetes-specific distress using 20 items and a five-point Likert scale (0 - 4). Item scores are summed and transformed to a range from 0 - 100 with higher scores indicating higher distress. Based on the measurement of diabetes-specific distress at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.
Measured: Baseline, 12 month FU
Diabetes Self-Care (SDSCA Score)
The Summary of Diabetes Self-Care Activities Measure (SDSCA) was used to assess diabetes self-care. The SDSCA assesses the number of days of the previous week (0 - 7) on which several specific self-care activities (appropriate diet, physical activity, self-monitoring of blood glucose, foot care) were performed. The item scores are summed and averaged to a total score from 0 to 7 with higher scores indicating better overall self-care. Based on the measurement of diabetes self-care at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.
Measured: Baseline, 12 month FU
Diabetes Acceptance (AADQ Score)
The Acceptance and Action Diabetes Questionnaire (AADQ) was used to assessment of diabetes acceptance. Using 11 items on diabetes-related experiential avoidance behaviours and a 5-point Likert response scale (1 - 5), the AADQ estimates the overall level of diabetes acceptance. Item scores are summed to a total score between 11 and 55 with higehr scores indicating better acceptance. Based on the measurement of diabetes acceptance at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.
Measured: Baseline, 12 month FU
Glycemic Control (HbA1c)
The HbA1c was used as measure of glycemic control. All blood samples were analysed in a central laboratory using the Bio-Rad II Turbo analyser; the measurement units were %-points. Based on the measurement at baseline and 12-month follow up, the difference of the HbA1c values between baseline and 12 month follow up was calculated.
Measured: Baseline, 12 month FU
Inflammatory Marker IL-6
The inflammatory marker Interleukin 6 (IL-6) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.
Measured: Baseline, 12 month FU
Inflammatory Marker IL-1Ra
The inflammatory marker Interleukin 1 receptor antagonist (IL-1Ra) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.
Measured: Baseline, 12 month FU
Inflammatory Marker Hs-CRP
The inflammatory marker high sensitivity C-reactive protein (hs-CRP) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.
Measured: Baseline, 12 month FU
Health-care Costs: Health-care Utilisation
Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.
Measured: Baseline, 12 months-FU
Health-care Costs: Non-productive Time
Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.
Measured: Baseline, 12 months-FU
Health-care Costs: Medication Intake
Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.
Measured: Baseline, 12 months-FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies 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
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forschungsinstitut der Diabetes Akademie Mergentheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Diabetes Center, University of Giessen, Heinrich-Heine University, Duesseldorf
- Responsible party
- Principal investigator, Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
- Investigators
- Bernhard Kulzer, PhD, Principal investigator, Forschungsinstitut der Diabetes Akademie Mergentheim e. V.Norbert Hermanns, Prof., PhD, Principal investigator, Forschungsinstitut der Diabetes Akademie Mergentheim e. V.Thomas J Haak, Prof., MD, Study director, Diabetes Zentrum Mergentheim; Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009138
- Sponsor's protocol ID
- FKZ 01GI0809
- Status last verified
- Sep 2022
- First submitted
- 5 Nov 2009
- Last updated
- 6 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26696661Hermanns 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.
PubMed 26696662Hermanns 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.
PubMed 25605812Reimer 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.
PubMed 28700718Schmitt 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.
PubMed 28865713Chernyak 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.
PubMed 20959009
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Diabetes-specific Cognitive Behavioural Treatment (DS-CBT) for Diabetic Patients With Subthreshold Depression
- ClinicalTrials.gov ID
- NCT01009138
- Acronym / sponsor ID
- FKZ 01GI0809
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Forschungsinstitut der Diabetes Akademie MergentheimUniversity, hospital or other
- Collaborators
- German Diabetes Center, University of Giessen, Heinrich-Heine University, Duesseldorf
- Study start
- Nov 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Posted 26 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Experimental | Behavioral: Diabetes-Specific CBT (DS-CBT)Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems |
| Standard Diabetes Education | Active comparator | Behavioral: Standard Diabetes EducationStandard Diabetes Education Lessons will be given to quantify the unspecific antidepressive Effects of Participation in Group Sessions with social Contact and Acquisition of Knowledge. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes mellitus
- Elevated depressive symptoms (regarding to CES-D)
- Age >= 18 and <=70
- Sufficient German language skills
- Informed consent
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| Diabetes-Specific CBT (DS-CBT)Also: Diabetes-Specific Cognitive-Behavioral Group Sessions5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles: * Problem Analysis and Definition * Problem Solving Intervention * Cognitive Restructuring * Activation of personal and social Resources * Goal Definition and Agreement | Behavioural | Diabetes-Specific CBT (DS-CBT) |
| Standard Diabetes EducationAlso: Educative Group Lesson and DiscussionStandard Diabetes Education Lesson including * Health Care and specific Topics (e. g. Blood Pressure) * Social Aspects of Living with Diabetes * Diabetes Complications * Sports, Activities and Exercise * Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes * Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy | Behavioural | Standard Diabetes Education |
Primary outcome
Depressive Symptoms (CES-D Score)
Time frame: Baseline, 12 month FU
The Center for Epidemiologic Studies Depression Scale (CES-D) was used to assess depressive symptoms. The CES-D assesses the frequency of 20 typical symptoms of depression during the previous week on a 4-point Likert scale. Summing of the item scores estimates the total score with a range between 0 and 60 and higher scores indicating more severe depressive mood. Based on the measurement of depressive symptoms at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.
11 secondary outcomes
Quality of Life (EQ-5D TTO Score)
Time frame: Baseline,12 month FU
Diabetes-specific Distress (PAID Score)
Time frame: Baseline, 12 month FU
Diabetes Self-Care (SDSCA Score)
Time frame: Baseline, 12 month FU
Diabetes Acceptance (AADQ Score)
Time frame: Baseline, 12 month FU
Glycemic Control (HbA1c)
Time frame: Baseline, 12 month FU
Inflammatory Marker IL-6
Time frame: Baseline, 12 month FU
Inflammatory Marker IL-1Ra
Time frame: Baseline, 12 month FU
Inflammatory Marker Hs-CRP
Time frame: Baseline, 12 month FU
Health-care Costs: Health-care Utilisation
Time frame: Baseline, 12 months-FU
Health-care Costs: Non-productive Time
Time frame: Baseline, 12 months-FU
Health-care Costs: Medication Intake
Time frame: Baseline, 12 months-FU
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26696661Tulu 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.
- Background: PubMed 26696662Hermanns 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.
- Results publication: PubMed 25605812Hermanns 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.
- Results publication: PubMed 28700718Reimer 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.
- Results publication: PubMed 28865713Schmitt 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.
- Derived from this study: PubMed 20959009Chernyak 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.
Related trials for Depressive Symptoms
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
RecruitingPhase 1
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Vasopressin Deficiency
Recruiting
Psychopharmacotherapy for Depressive Patients
Major Depressive Disorder
RecruitingObservational study
Characterization and Treatment of Adolescent Depression
Depression
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, PhD principal investigator
Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
Norbert Hermanns, Prof., PhD principal investigator
Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
Thomas J Haak, Prof., MD study director
Diabetes Zentrum Mergentheim; Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes-Specific CBT (DS-CBT) and Standard Diabetes Education in people with Depressive Symptoms and Diabetes Mellitus, 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 7 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 6 Oct 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?
Yes. Results are posted in the registry (first posted 26 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Symptoms (CES-D Score) (time frame: Baseline, 12 month FU). 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 NCT01009138, which also lists 6 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 6 Oct 2022.