Depressive Symptoms, Diabetes Mellitus
Conditions
Keywords
Subthreshold Depression, Diabetes-related Distress, Minor Depression, Light affective Disorder, Subclinical depressive Symptoms, Diabetes mellitus, Late Complications, Markers of Inflammation
Brief 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. 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.
Interventions
BEHAVIORALDiabetes-Specific CBT (DS-CBT)
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
BEHAVIORALStandard Diabetes Education
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
Sponsors
German Diabetes Center
University of Giessen
Heinrich-Heine University, Duesseldorf
Forschungsinstitut der Diabetes Akademie Mergentheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diabetes mellitus * Elevated depressive symptoms (regarding to CES-D) * Age \>= 18 and \<=70 * Sufficient German language skills * Informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms (CES-D Score) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes-specific Distress (PAID Score) | Baseline, 12 month FU | 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. |
| Diabetes Self-Care (SDSCA Score) | Baseline, 12 month FU | 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. |
| Diabetes Acceptance (AADQ Score) | Baseline, 12 month FU | 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. |
| Glycemic Control (HbA1c) | Baseline, 12 month FU | 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. |
| Inflammatory Marker IL-6 | Baseline, 12 month FU | 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. |
| Quality of Life (EQ-5D TTO Score) | Baseline,12 month FU | 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. |
| Inflammatory Marker Hs-CRP | Baseline, 12 month FU | 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. |
| Health-care Costs: Health-care Utilisation | Baseline, 12 months-FU | 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. |
| Health-care Costs: Non-productive Time | Baseline, 12 months-FU | 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. |
| Health-care Costs: Medication Intake | Baseline, 12 months-FU | 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. |
| Inflammatory Marker IL-1Ra | Baseline, 12 month FU | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diabetes-Specific CBT (DS-CBT) Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems
Diabetes-Specific CBT (DS-CBT): 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 | 106 |
| Standard Diabetes Education Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.
Standard Diabetes Education: 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 | 108 |
| Total | 214 |
Baseline characteristics
| Characteristic | Diabetes-Specific CBT (DS-CBT) | Standard Diabetes Education | Total |
|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 15 | 43 years STANDARD_DEVIATION 14 | 43 years STANDARD_DEVIATION 13 |
| BMI (kg/m2) | 30 kg/m2 STANDARD_DEVIATION 8 | 28 kg/m2 STANDARD_DEVIATION 6 | 29 kg/m2 STANDARD_DEVIATION 7 |
| Diabetes duration | 14 years STANDARD_DEVIATION 10 | 14 years STANDARD_DEVIATION 11 | 14 years STANDARD_DEVIATION 11 |
| HbA1c (%-points) | 8.9 %-points STANDARD_DEVIATION 1.8 | 8.9 %-points STANDARD_DEVIATION 1.8 | 8.9 %-points STANDARD_DEVIATION 1.8 |
| Sex: Female, Male Female | 60 Participants | 61 Participants | 121 Participants |
| Sex: Female, Male Male | 46 Participants | 47 Participants | 93 Participants |
| Type 1 diabetes | 63 participants | 78 participants | 141 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 106 | 28 / 108 |
| serious Total, serious adverse events | 11 / 106 | 21 / 108 |
Outcome results
Primary
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.
Time frame: Baseline, 12 month FU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Depressive Symptoms (CES-D Score) | -7.4 Scores on a scale | Standard Deviation 11.4 |
| Standard Diabetes Education | Depressive Symptoms (CES-D Score) | -2.7 Scores on a scale | Standard Deviation 11.7 |
Secondary
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.
Time frame: Baseline, 12 month FU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Diabetes Acceptance (AADQ Score) | 2.5 Scores on a scale | Standard Deviation 7.7 |
| Standard Diabetes Education | Diabetes Acceptance (AADQ Score) | 2.0 Scores on a scale | Standard Deviation 6.6 |
Secondary
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.
Time frame: Baseline, 12 month FU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Diabetes Self-Care (SDSCA Score) | -0.1 Scores on a scale | Standard Deviation 1.1 |
| Standard Diabetes Education | Diabetes Self-Care (SDSCA Score) | 0.0 Scores on a scale | Standard Deviation 1 |
Secondary
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.
Time frame: Baseline, 12 month FU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Diabetes-specific Distress (PAID Score) | -13.0 Scores on a scale | Standard Deviation 18.9 |
| Standard Diabetes Education | Diabetes-specific Distress (PAID Score) | -4.2 Scores on a scale | Standard Deviation 16.9 |
Secondary
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.
Time frame: Baseline, 12 month FU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Glycemic Control (HbA1c) | -0.5 %-points | Standard Deviation 2 |
| Standard Diabetes Education | Glycemic Control (HbA1c) | -0.7 %-points | Standard Deviation 1.7 |
Secondary
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.
Time frame: Baseline, 12 months-FU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Health-care Costs: Health-care Utilisation | -2.2 number of medical appointment/half year | Standard Deviation 15.4 |
| Standard Diabetes Education | Health-care Costs: Health-care Utilisation | -1.4 number of medical appointment/half year | Standard Deviation 13.3 |
Secondary
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.
Time frame: Baseline, 12 months-FU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Health-care Costs: Medication Intake | 0.7 number of daily medications/half year | Standard Deviation 1.6 |
| Standard Diabetes Education | Health-care Costs: Medication Intake | 0.8 number of daily medications/half year | Standard Deviation 2 |
Secondary
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.
Time frame: Baseline, 12 months-FU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Health-care Costs: Non-productive Time | -2.2 number of days on sick leave/half year | Standard Deviation 33.2 |
| Standard Diabetes Education | Health-care Costs: Non-productive Time | 5.8 number of days on sick leave/half year | Standard Deviation 30.2 |
Secondary
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.
Time frame: Baseline, 12 month FU
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Inflammatory Marker Hs-CRP | 0.0 mg/dl |
| Standard Diabetes Education | Inflammatory Marker Hs-CRP | 0.0 mg/dl |
Secondary
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.
Time frame: Baseline, 12 month FU
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Inflammatory Marker IL-1Ra | -100.5 pg/ml |
| Standard Diabetes Education | Inflammatory Marker IL-1Ra | -70.8 pg/ml |
Secondary
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.
Time frame: Baseline, 12 month FU
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Inflammatory Marker IL-6 | 0.0 pg/ml |
| Standard Diabetes Education | Inflammatory Marker IL-6 | 0.1 pg/ml |
Secondary
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.
Time frame: Baseline,12 month FU
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes-Specific CBT (DS-CBT) | Quality of Life (EQ-5D TTO Score) | -0.01 Scores on a scale | Standard Deviation 0.23 |
| Standard Diabetes Education | Quality of Life (EQ-5D TTO Score) | -0.01 Scores on a scale | Standard Deviation 0.25 |