Depression and Diabetes Control Trial (DDCT)

August 27, 2018 updated by: Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
213

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Bad Mergentheim, BW, Germany, 97980
        • Diabetes Center Mergentheim
    • Baden-Württemberg
      • Bad Mergentheim, Baden-Württemberg, Germany, 97980
        • Forschungsinstitut der Diabetes Akademie Mergentheim e. V.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive-behavioural group treatment

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
Behavioral: Diabetes-related affective problems analysis
Analysis of diabetes-related affective problems with regard to suboptimal glycaemic control
Behavioral: Goal setting towards improvement of glycaemic control
Discussing and setting goals regarding improvements of suboptimal glycaemic control, depressive symptoms and diabetes distress
Behavioral: Diabetes-specific problem-solving therapy
Diabetes-specific problem-solving therapy with main focus on suboptimal glycaemic control, depressive symptoms and diabetes distress
Behavioral: Interventions to increase diabetes treatment motivation
Interventions to increase diabetes treatment motivation in order to achieve improvements of glycaemic control as well as recovery from affective problems
Behavioral: Activation of personal and social resources
Activation of personal and social resources with a view to diabetes control and affective problems
Behavioral: Reduction of barriers to self-care/glycaemic control
Definition and reduction of barriers to adequate diabetes self-care behaviour as well as good glycaemic control
Behavioral: Cognitive restructuring of diabetes-related problems
Cognitive restructuring of diabetes-related problems such as suboptimal glycaemic control and diabetes-related affective problems
Behavioral: Goal definition regarding self-care/glycaemia/well-being
Goal definition and agreement regarding diabetes self-care behaviour, optimal glycaemic control and activities supporting well-being and recovery from affective symptoms
Active Comparator: Treatment-as-usual

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
Behavioral: Health care and specific topics (e. g. blood pressure)
Education on health care and specific topics (e. g. blood pressure)
Behavioral: Healthy foods, cooking recommendations, recipes
Education on healthy and unhealthy foods, cooking and recipes
Behavioral: Sports, activities and exercise
Education on sports, activities and exercise
Behavioral: Foot care: exercises, care & control, injuries, neuropathy
Education on foot care: exercises, care and control, injuries, and diabetic neuropathy
Behavioral: Diabetes complications
Education on diabetes complications
Behavioral: Social aspects of living with diabetes
Education on social aspects of living with diabetes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
12 months
Improvement of depressive symptoms as measured with the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: 12 months
Mean difference between CES-D scores at baseline and at 12 month follow up
12 months
Improvement of depressive symptoms as measured with the Patient Health Questionnaire Module for Depression (PHQ-9)
Time Frame: 12 months
Mean difference between PHQ-9 scores at baseline and at 12 month follow up
12 months
IImprovement of diabetes distress as measured with the Problem Areas in Diabetes Scale (PAID)
Time Frame: 12 months
Mean difference between PAID scores at baseline and at 12 month follow
12 months
IImprovement of diabetes distress as measured with the Diabetes Distress Scale (DDS)
Time Frame: 12 months
Mean difference between DDS scores at baseline and at 12 month follow
12 months
Improvement of self-care behaviour as measured with the Summary of Diabetes Self-Care Activities Measure (SDSCA)
Time Frame: 12 months
Mean difference between SDSCA scores at baseline and at 12 month follow
12 months
Improvement of self-care behaviour as measured with the Diabetes Self-Management Questionnaire (DSMQ)
Time Frame: 12 months
Mean difference between DSMQ scores at baseline and at 12 month follow
12 months
Improvement of diabetes acceptance as measured with the Diabetes Acceptance Scale (DAS)
Time Frame: 12 months
Mean difference between DAS scores at baseline and at 12 month follow
12 months
Improvement of quality of life as measured with the EuroQol Five-Dimensions Questionnaire (EQ-5D)
Time Frame: 12 months
Mean difference between EQ-5D scores at baseline and at 12 month follow
12 months
Improvement of quality of life as measured with the Short Form-36 Health Survey (SF-36)
Time Frame: 12 months
Mean difference between SF-36 scores at baseline and at 12 month follow
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Inflammatory Marker: hsCRP
Time Frame: 12 months
Mean difference between hsCRP scores at baseline and at 12 month follow
12 months
Inflammatory Marker: IL-6
Time Frame: 12 months
Mean difference between IL-6 scores at baseline and at 12 month follow
12 months
Inflammatory Marker: IL-18
Time Frame: 12 months
Mean difference between IL-18 scores at baseline and at 12 month follow
12 months
Inflammatory Marker: IL-1Ra
Time Frame: 12 months
Mean difference between IL-1Ra scores at baseline and at 12 month follow
12 months
Inflammatory Marker: MCP-1
Time Frame: 12 months
Mean difference between MCP-1 scores at baseline and at 12 month follow
12 months
Inflammatory Marker: Adiponectin
Time Frame: 12 months
Mean difference between Adiponectin scores at baseline and at 12 month follow
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Forschungsinstitut der Diabetes Akademie Mergentheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Federal Ministry of Education and Research
Helmholtz Zentrum München
German Diabetes Center
German Center for Diabetes Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Haak, Prof., MD, Diabetes Center Mergentheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FKZ 82DZD01101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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