Diabetes MellitusDDCTNCT02675257
Depression and Diabetes Control Trial
A study testing Diabetes-related affective problems analysis, Diabetes-specific problem-solving therapy and Interventions to increase diabetes treatment motivation in people with Diabetes Mellitus and Affective Disorders, run by Forschungsinstitut der Diabetes Akademie Mergentheim at 2 sites in Germany.
Trial summary
This randomised controlled trial evaluates a cognitive-behavioural intervention for diabetes patients with suboptimal glycaemic control and comorbid depressive symptoms and/or diabetes distress. The main outcome is the improvement of suboptimal glycaemic control (HbA1c). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Affective Disorders, Depression
- What is being tested?
- Diabetes-related affective problems analysis, Diabetes-specific problem-solving therapy and Interventions to increase diabetes treatment motivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jul 2015to 30 Jun 2018
- 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 between 18 and 70
- Diabetes mellitus type 1 or type 2
- Diabetes duration ≥ 1 year
- Suboptimal glycaemic control (HbA1c > 7,5%)
- Elevated depressive symptoms (CES-D score ≥ 16) and/or elevated diabetes distress (PAID score ≥ 40)
- Sufficient language skills
- Written informed consent
Who cannot join
- Severe major depressive disorder according to ICD-10
- Current psychiatric and/or psychotherapeutic treatment
- Current antidepressive medical treatment
- Suicidal ideation
- Acute mental disorder of the following type: schizophrenia or other psychotic disorder, bipolar disorder, severe eating disorder (anorexia nervosa, bulimia nervosa), substance use disorder
- History of personality disorder
Show all 10Show fewer
- Severe somatic illnesses: dialysis-dependent nephropathy, acute cancer, severe heart disease (NYHA III - IV), severe neurologic illness (e. g. MS, dementia), severe autoimmune disease
- Terminal illness
- Bedriddenness
- Guardianship
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Diabetes Center Mergentheim
Bad Mergentheim, Baden-Wurttemberg, 97980
Forschungsinstitut der Diabetes Akademie Mergentheim e. V.
Bad Mergentheim, Baden-Wurttemberg, 97980
About this study
This randomised controlled trial evaluates a cognitive-behavioural intervention for diabetes patients with suboptimal glycaemic control and comorbid depressive symptoms and/or diabetes distress. The main outcome is the improvement of suboptimal glycaemic control (HbA1c). Secondary outcomes are effects on depressive symptoms, diabetes distress, self-care behaviour, diabetes acceptance and quality of life. The treatment group will be treated with a cognitive-behavioural group treatment comprising specific interventions to improve glycaemic control and reduce diabetes distress as well as depressive symptoms. The control group will receive treatment-as-usual. A total of 212 study participants will be included. A secondary study objective is to analyse associations of suboptimal glycaemic control, depressive symptoms and diabetes distress with inflammatory markers.
Read the detailed description
Suboptimal glycaemic control is an established risk factor for the development of serious long-term complications of diabetes. Moreover, it is associated with elevated risks of significant hyperglycaemic acute events such as hyperosmolar hyperglycemic state or diabetic ketoacidosis. Hence, patients with diabetes and persistent suboptimal glycaemic control are at higher risk of having a rather poor prognosis.
Besides physiological and medical factors, psychological problems have been found to predict suboptimal glycaemic control. A number of studies found depressive symptoms to be independently associated with hyperglycaemia. Others focussed on diabetes-specific affective problems - the so called diabetes distress - and suggested this factor to be of great importance. Finally, some studies found that depressive symptoms and diabetes distress may interact, with the coocurrence of these factors being associated with the highest risk or suboptimal glycaemic control. The results correspond to other findings suggesting that both depressive symptoms and diabetes distress are often associated with reduced diabetes self-care, which can explain the associations of those factors with hyperglycaemia.
On the other hand, suboptimal glycaemic control could also be an explanation for affective problems - either mediated by physiological mechanisms or psychological ones, e.g. dissatisfaction or guilt. Hence, it is valid to assume that the link between depressive symptoms and/or diabetes distress may be bidirectional - although evidence to support this assumption is missing.
Following this evidence and background, the investigators designed the a to analyse the relationships between suboptimal glycaemic control, depressive symptoms and diabetes distress in diabetes using a prospective study design. The study is a randomized trial in which a cognitive-behavioural group treatment is compared to a treatment-as-usual condition (standard diabetes education) regarding their efficacy in improving suboptimal glycaemic control. 212 diabetes patients with suboptimal glycaemic control (HbA1c value > 7.5%) and elevated depressive symptoms (Center for Epidemiologic Studies Depressions Scale score ≥ 16) and/or elevated diabetes distress (Problem Areas In Diabetes Scale score ≥ 40) will be randomly assigned to either the treatment group or treatment-as-usual. The primary outcome is the improvement of suboptimal glycaemic control (reduction of HbA1c) in the 12-month follow-up. As secondary outcomes positive baseline-to-follow up changes regarding depressive symptoms, diabetes distress, diabetes self-care behaviour, diabetes acceptance and quality of life are assessed.
A second study objective is to analyse cross-sectional and prospective associations of suboptimal glycaemic control, depressive symptoms and diabetes distress with serum levels of the following inflammatory markers: hsCRP, IL-6, IL-18, IL-1Ra, MCP-1 and Adiponectin. Potential effects of the treatment groups on these markers will also be examined.
- Conditions
- Diabetes Mellitus, Affective Disorders, Depression, Depressive Symptoms, Emotional Distress, Diabetes Complications
- Being tested
- Diabetes-related affective problems analysis, Goal setting towards improvement of glycaemic control, Diabetes-specific problem-solving therapy, Interventions to increase diabetes treatment motivation, Activation of personal and social resources
- Keywords
- Diabetes mellitus, Affective disorders, Depressive symptoms, Diabetes distress, Hyperglycaemia, Dysglycaemia, Glycaemic control, Self-care behaviour, Quality of Life, Diabetes acceptance, Diabetes complications, Low-grade inflammation, Inflammatory markers, Stress reactivity, Health-care costs
- Medical subject headings
- Diabetes Mellitus, Mood Disorders, Depression, Diabetes Complications, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes-related affective problems analysisBehavioural
Analysis of diabetes-related affective problems with regard to suboptimal glycaemic control
Goal setting towards improvement of glycaemic controlBehavioural
Discussing and setting goals regarding improvements of suboptimal glycaemic control, depressive symptoms and diabetes distress
Diabetes-specific problem-solving therapyBehavioural
Diabetes-specific problem-solving therapy with main focus on suboptimal glycaemic control, depressive symptoms and diabetes distress
Interventions to increase diabetes treatment motivationBehavioural
Interventions to increase diabetes treatment motivation in order to achieve improvements of glycaemic control as well as recovery from affective problems
Activation of personal and social resourcesBehavioural
Activation of personal and social resources with a view to diabetes control and affective problems
Reduction of barriers to self-care/glycaemic controlBehavioural
Definition and reduction of barriers to adequate diabetes self-care behaviour as well as good glycaemic control
Cognitive restructuring of diabetes-related problemsBehavioural
Cognitive restructuring of diabetes-related problems such as suboptimal glycaemic control and diabetes-related affective problems
Goal definition regarding self-care/glycaemia/well-beingBehavioural
Goal definition and agreement regarding diabetes self-care behaviour, optimal glycaemic control and activities supporting well-being and recovery from affective symptoms
Health care and specific topics (e. g. blood pressure)Behavioural
Education on health care and specific topics (e. g. blood pressure)
Healthy foods, cooking recommendations, recipesBehavioural
Education on healthy and unhealthy foods, cooking and recipes
Sports, activities and exerciseBehavioural
Education on sports, activities and exercise
Foot care: exercises, care & control, injuries, neuropathyBehavioural
Education on foot care: exercises, care and control, injuries, and diabetic neuropathy
Diabetes complicationsBehavioural
Education on diabetes complications
Social aspects of living with diabetesBehavioural
Education on social aspects of living with diabetes
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioural group treatment | Experimental | Five group sessions of diabetes-Specific cognitive-behavioural group treatment for diabetes patients with depressive symptoms and/or diabetes distress and suboptimal glycaemic control.
Interventions:
* Diabetes-related affective problems analysis
* Goal setting towards improvement of glycaemic control
* Diabetes-specific problem-solving therapy
* Interventions to increase diabetes treatment motivation
* Activation of personal and social resources
* Reduction of barriers to self-care/glycaemic control
* Cognitive restructuring of diabetes-related problems
* Goal definition regarding self-care/glycaemia/well-being Receives: Behavioral: Diabetes-related affective problems analysis; Behavioral: Goal setting towards improvement of glycaemic control; Behavioral: Diabetes-specific problem-solving therapy; Behavioral: Interventions to increase diabetes treatment motivation; Behavioral: Activation of personal and social resources; Behavioral: Reduction of barriers to self-care/glycaemic control; Behavioral: Cognitive restructuring of diabetes-related problems; Behavioral: Goal definition regarding self-care/glycaemia/well-being |
| Treatment-as-usual | Active comparator | Standard diabetes education.
Interventions:
* Health care and specific topics (e. g. blood pressure)
* Healthy foods, cooking recommendations, recipes
* Sports, activities and exercise
* Foot care: exercises, care \& control, injuries, neuropathy
* Diabetes complications
* Social aspects of living with diabetes Receives: Behavioral: Health care and specific topics (e. g. blood pressure); Behavioral: Healthy foods, cooking recommendations, recipes; Behavioral: Sports, activities and exercise; Behavioral: Foot care: exercises, care & control, injuries, neuropathy; Behavioral: Diabetes complications; Behavioral: Social aspects of living with diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of glycaemic control as measured by the HbA1c
Mean difference between HbA1c values at baseline and at 12 month follow
Measured: 12 months
Secondary outcomes (10)
Improvement of glycaemic control as measured by participants' blood glucose meter or glucose monitoring devices (data are extracted from tools using the diasend application)
Mean difference between average glucose test scores during an 8-week period before baseline and those during an 8-week period before 12 month follow
Measured: 12 months
Improvement of depressive symptoms as measured with the Center for Epidemiologic Studies Depression Scale (CES-D)
Mean difference between CES-D scores at baseline and at 12 month follow up
Measured: 12 months
Improvement of depressive symptoms as measured with the Patient Health Questionnaire Module for Depression (PHQ-9)
Mean difference between PHQ-9 scores at baseline and at 12 month follow up
Measured: 12 months
IImprovement of diabetes distress as measured with the Problem Areas in Diabetes Scale (PAID)
Mean difference between PAID scores at baseline and at 12 month follow
Measured: 12 months
IImprovement of diabetes distress as measured with the Diabetes Distress Scale (DDS)
Mean difference between DDS scores at baseline and at 12 month follow
Measured: 12 months
Improvement of self-care behaviour as measured with the Summary of Diabetes Self-Care Activities Measure (SDSCA)
Mean difference between SDSCA scores at baseline and at 12 month follow
Measured: 12 months
Improvement of self-care behaviour as measured with the Diabetes Self-Management Questionnaire (DSMQ)
Mean difference between DSMQ scores at baseline and at 12 month follow
Measured: 12 months
Improvement of diabetes acceptance as measured with the Diabetes Acceptance Scale (DAS)
Mean difference between DAS scores at baseline and at 12 month follow
Measured: 12 months
Improvement of quality of life as measured with the EuroQol Five-Dimensions Questionnaire (EQ-5D)
Mean difference between EQ-5D scores at baseline and at 12 month follow
Measured: 12 months
Improvement of quality of life as measured with the Short Form-36 Health Survey (SF-36)
Mean difference between SF-36 scores at baseline and at 12 month follow
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start1 Jul 2015
- Primary completion31 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forschungsinstitut der Diabetes Akademie Mergentheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Diabetes Research, Helmholtz Zentrum München, German Diabetes Center, German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
- Investigators
- Thomas Haak, Prof., MD, Principal investigator, Diabetes Center Mergentheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675257
- Sponsor's protocol ID
- FKZ 82DZD01101
- Acronym
- DDCT
- Status last verified
- Aug 2018
- First submitted
- 2 Feb 2016
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Schmitt A, Ehrmann D, Kuniss N, Muller N, Kulzer B, Hermanns N. Assessing fear of complications in people with type 1 and type 2 diabetes with the Fear of Diabetes Complications Questionnaire. Health Psychol. 2023 Sep;42(9):674-685. doi: 10.1037/hea0001304. Epub 2023 Jul 27.
PubMed 37498716
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and Diabetes Control Trial
- ClinicalTrials.gov ID
- NCT02675257
- Acronym / sponsor ID
- DDCT / FKZ 82DZD01101
- Conditions
- Diabetes Mellitus, Affective Disorders, Depression, Depressive Symptoms, Emotional Distress, Diabetes Complications
- Keywords
- Diabetes mellitus, Affective disorders, Depressive symptoms, Diabetes distress, Hyperglycaemia, Dysglycaemia, Glycaemic control, Self-care behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Forschungsinstitut der Diabetes Akademie MergentheimUniversity, hospital or other
- Collaborators
- German Center for Diabetes Research, Helmholtz Zentrum München, German Diabetes Center, German Federal Ministry of Education and Research
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 5 Feb 2016 (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.
This randomised controlled trial evaluates a cognitive-behavioural intervention for diabetes patients with suboptimal glycaemic control and comorbid depressive symptoms and/or diabetes distress. The main outcome is the improvement of suboptimal glycaemic control (HbA1c). Secondary outcomes are effects on depressive symptoms, diabetes distress, self-care behaviour, diabetes acceptance and quality of life. The treatment group will be treated with a cognitive-behavioural group treatment comprising specific interventions to improve glycaemic control and reduce diabetes distress as well as depressive symptoms. The control group will receive treatment-as-usual. A total of 212 study participants will be included. A secondary study objective is to analyse associations of suboptimal glycaemic control, depressive symptoms and diabetes distress with inflammatory markers.
Detailed description
Suboptimal glycaemic control is an established risk factor for the development of serious long-term complications of diabetes. Moreover, it is associated with elevated risks of significant hyperglycaemic acute events such as hyperosmolar hyperglycemic state or diabetic ketoacidosis. Hence, patients with diabetes and persistent suboptimal glycaemic control are at higher risk of having a rather poor prognosis.
Besides physiological and medical factors, psychological problems have been found to predict suboptimal glycaemic control. A number of studies found depressive symptoms to be independently associated with hyperglycaemia. Others focussed on diabetes-specific affective problems - the so called diabetes distress - and suggested this factor to be of great importance. Finally, some studies found that depressive symptoms and diabetes distress may interact, with the coocurrence of these factors being associated with the highest risk or suboptimal glycaemic control. The results correspond to other findings suggesting that both depressive symptoms and diabetes distress are often associated with reduced diabetes self-care, which can explain the associations of those factors with hyperglycaemia.
On the other hand, suboptimal glycaemic control could also be an explanation for affective problems - either mediated by physiological mechanisms or psychological ones, e.g. dissatisfaction or guilt. Hence, it is valid to assume that the link between depressive symptoms and/or diabetes distress may be bidirectional - although evidence to support this assumption is missing.
Following this evidence and background, the investigators designed the a to analyse the relationships between suboptimal glycaemic control, depressive symptoms and diabetes distress in diabetes using a prospective study design. The study is a randomized trial in which a cognitive-behavioural group treatment is compared to a treatment-as-usual condition (standard diabetes education) regarding their efficacy in improving suboptimal glycaemic control. 212 diabetes patients with suboptimal glycaemic control (HbA1c value > 7.5%) and elevated depressive symptoms (Center for Epidemiologic Studies Depressions Scale score ≥ 16) and/or elevated diabetes distress (Problem Areas In Diabetes Scale score ≥ 40) will be randomly assigned to either the treatment group or treatment-as-usual. The primary outcome is the improvement of suboptimal glycaemic control (reduction of HbA1c) in the 12-month follow-up. As secondary outcomes positive baseline-to-follow up changes regarding depressive symptoms, diabetes distress, diabetes self-care behaviour, diabetes acceptance and quality of life are assessed.
A second study objective is to analyse cross-sectional and prospective associations of suboptimal glycaemic control, depressive symptoms and diabetes distress with serum levels of the following inflammatory markers: hsCRP, IL-6, IL-18, IL-1Ra, MCP-1 and Adiponectin. Potential effects of the treatment groups on these markers will also be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioural group treatment | Experimental | Behavioral: Diabetes-related affective problems analysis, Behavioral: Goal setting towards improvement of glycaemic control, Behavioral: Diabetes-specific problem-solving therapy, Behavioral: Interventions to increase diabetes treatment motivation, Behavioral: Activation of personal and social resources, Behavioral: Reduction of barriers to self-care/glycaemic control, Behavioral: Cognitive restructuring of diabetes-related problems, Behavioral: Goal definition regarding self-care/glycaemia/well-beingFive group sessions of diabetes-Specific cognitive-behavioural group treatment for diabetes patients with depressive symptoms and/or diabetes distress and suboptimal glycaemic control. Interventions: * Diabetes-related affective problems analysis * Goal setting towards improvement of glycaemic control * Diabetes-specific problem-solving therapy * Interventions to increase diabetes treatment motivation * Activation of personal and social resources * Reduction of barriers to self-care/glycaemic control * Cognitive restructuring of diabetes-related problems * Goal definition regarding self-care/glycaemia/well-being |
| Treatment-as-usual | Active comparator | Behavioral: Health care and specific topics (e. g. blood pressure), Behavioral: Healthy foods, cooking recommendations, recipes, Behavioral: Sports, activities and exercise, Behavioral: Foot care: exercises, care & control, injuries, neuropathy, Behavioral: Diabetes complications, Behavioral: Social aspects of living with diabetesStandard diabetes education. Interventions: * Health care and specific topics (e. g. blood pressure) * Healthy foods, cooking recommendations, recipes * Sports, activities and exercise * Foot care: exercises, care \& control, injuries, neuropathy * Diabetes complications * Social aspects of living with diabetes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 70
- Diabetes mellitus type 1 or type 2
- Diabetes duration ≥ 1 year
- Suboptimal glycaemic control (HbA1c > 7,5%)
- Elevated depressive symptoms (CES-D score ≥ 16) and/or elevated diabetes distress (PAID score ≥ 40)
Key exclusion criteria (10 listed)
- Severe major depressive disorder according to ICD-10
- Current psychiatric and/or psychotherapeutic treatment
- Current antidepressive medical treatment
- Suicidal ideation
- Acute mental disorder of the following type: schizophrenia or other psychotic disorder, bipolar disorder, severe eating disorder (anorexia nervosa, bulimia nervosa), substance use 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 |
|---|---|---|
| Diabetes-related affective problems analysisAnalysis of diabetes-related affective problems with regard to suboptimal glycaemic control | Behavioural | Cognitive-behavioural group treatment |
| Goal setting towards improvement of glycaemic controlDiscussing and setting goals regarding improvements of suboptimal glycaemic control, depressive symptoms and diabetes distress | Behavioural | Cognitive-behavioural group treatment |
| Diabetes-specific problem-solving therapyDiabetes-specific problem-solving therapy with main focus on suboptimal glycaemic control, depressive symptoms and diabetes distress | Behavioural | Cognitive-behavioural group treatment |
| Interventions to increase diabetes treatment motivationInterventions to increase diabetes treatment motivation in order to achieve improvements of glycaemic control as well as recovery from affective problems | Behavioural | Cognitive-behavioural group treatment |
| Activation of personal and social resourcesActivation of personal and social resources with a view to diabetes control and affective problems | Behavioural | Cognitive-behavioural group treatment |
| Reduction of barriers to self-care/glycaemic controlDefinition and reduction of barriers to adequate diabetes self-care behaviour as well as good glycaemic control | Behavioural | Cognitive-behavioural group treatment |
| Cognitive restructuring of diabetes-related problemsCognitive restructuring of diabetes-related problems such as suboptimal glycaemic control and diabetes-related affective problems | Behavioural | Cognitive-behavioural group treatment |
| Goal definition regarding self-care/glycaemia/well-beingGoal definition and agreement regarding diabetes self-care behaviour, optimal glycaemic control and activities supporting well-being and recovery from affective symptoms | Behavioural | Cognitive-behavioural group treatment |
| Health care and specific topics (e. g. blood pressure)Education on health care and specific topics (e. g. blood pressure) | Behavioural | Treatment-as-usual |
| Healthy foods, cooking recommendations, recipesEducation on healthy and unhealthy foods, cooking and recipes | Behavioural | Treatment-as-usual |
| Sports, activities and exerciseEducation on sports, activities and exercise | Behavioural | Treatment-as-usual |
| Foot care: exercises, care & control, injuries, neuropathyEducation on foot care: exercises, care and control, injuries, and diabetic neuropathy | Behavioural | Treatment-as-usual |
| Diabetes complicationsEducation on diabetes complications | Behavioural | Treatment-as-usual |
| Social aspects of living with diabetesEducation on social aspects of living with diabetes | Behavioural | Treatment-as-usual |
Primary outcome
Improvement of glycaemic control as measured by the HbA1c
Time frame: 12 months
Mean difference between HbA1c values at baseline and at 12 month follow
10 secondary outcomes
Improvement of glycaemic control as measured by participants' blood glucose meter or glucose monitoring devices (data are extracted from tools using the diasend application)
Time frame: 12 months
Improvement of depressive symptoms as measured with the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 12 months
Improvement of depressive symptoms as measured with the Patient Health Questionnaire Module for Depression (PHQ-9)
Time frame: 12 months
IImprovement of diabetes distress as measured with the Problem Areas in Diabetes Scale (PAID)
Time frame: 12 months
IImprovement of diabetes distress as measured with the Diabetes Distress Scale (DDS)
Time frame: 12 months
Improvement of self-care behaviour as measured with the Summary of Diabetes Self-Care Activities Measure (SDSCA)
Time frame: 12 months
Improvement of self-care behaviour as measured with the Diabetes Self-Management Questionnaire (DSMQ)
Time frame: 12 months
Improvement of diabetes acceptance as measured with the Diabetes Acceptance Scale (DAS)
Time frame: 12 months
Improvement of quality of life as measured with the EuroQol Five-Dimensions Questionnaire (EQ-5D)
Time frame: 12 months
Improvement of quality of life as measured with the Short Form-36 Health Survey (SF-36)
Time frame: 12 months
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 28 Aug 2018.
- Derived from this study: PubMed 37498716Schmitt A, Ehrmann D, Kuniss N, Muller N, Kulzer B, Hermanns N. Assessing fear of complications in people with type 1 and type 2 diabetes with the Fear of Diabetes Complications Questionnaire. Health Psychol. 2023 Sep;42(9):674-685. doi: 10.1037/hea0001304. Epub 2023 Jul 27.
- Individual participant dataSharing planned: No
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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.
Thomas Haak, Prof., MD principal investigator
Diabetes Center Mergentheim
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes-related affective problems analysis, Diabetes-specific problem-solving therapy and Interventions to increase diabetes treatment motivation in people with Diabetes Mellitus and Affective Disorders, run by Forschungsinstitut der Diabetes Akademie Mergentheim at 2 sites 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 7 inclusion and 10 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 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Improvement of glycaemic control as measured by the HbA1c (time frame: 12 months). 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 NCT02675257, which also lists 1 linked publication.
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 28 Aug 2018.