Trial Outcomes & Findings for Evaluation of a Diabetes-specific Cognitive Behavioural Treatment for Subthreshold Depression (NCT NCT01009138)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

214 participants

Primary outcome timeframe

Baseline, 12 month FU

Results posted on

2022-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	106	108
Overall Study COMPLETED	93	88
Overall Study NOT COMPLETED	13	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Diabetes-specific Cognitive Behavioural Treatment for Subthreshold Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diabetes-Specific CBT (DS-CBT) n=106 Participants 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	Standard Diabetes Education n=108 Participants 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	Total n=214 Participants Total of all reporting groups
Age, Continuous	43 years STANDARD_DEVIATION 15 • n=5 Participants	43 years STANDARD_DEVIATION 14 • n=7 Participants	43 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	61 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Type 1 diabetes	63 participants n=5 Participants	78 participants n=7 Participants	141 participants n=5 Participants
Diabetes duration	14 years STANDARD_DEVIATION 10 • n=5 Participants	14 years STANDARD_DEVIATION 11 • n=7 Participants	14 years STANDARD_DEVIATION 11 • n=5 Participants
HbA1c (%-points)	8.9 %-points STANDARD_DEVIATION 1.8 • n=5 Participants	8.9 %-points STANDARD_DEVIATION 1.8 • n=7 Participants	8.9 %-points STANDARD_DEVIATION 1.8 • n=5 Participants
BMI (kg/m2)	30 kg/m2 STANDARD_DEVIATION 8 • n=5 Participants	28 kg/m2 STANDARD_DEVIATION 6 • n=7 Participants	29 kg/m2 STANDARD_DEVIATION 7 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diabetes-Specific CBT (DS-CBT) n=93 Participants 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	Standard Diabetes Education n=88 Participants 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
Depressive Symptoms (CES-D Score)	-7.4 Scores on a scale Standard Deviation 11.4	-2.7 Scores on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diabetes-Specific CBT (DS-CBT) n=93 Participants 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	Standard Diabetes Education n=88 Participants 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
Quality of Life (EQ-5D TTO Score)	-0.01 Scores on a scale Standard Deviation 0.23	-0.01 Scores on a scale Standard Deviation 0.25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diabetes-Specific CBT (DS-CBT) n=93 Participants 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	Standard Diabetes Education n=88 Participants 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
Diabetes-specific Distress (PAID Score)	-13.0 Scores on a scale Standard Deviation 18.9	-4.2 Scores on a scale Standard Deviation 16.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diabetes-Specific CBT (DS-CBT) n=93 Participants 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	Standard Diabetes Education n=88 Participants 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
Diabetes Self-Care (SDSCA Score)	-0.1 Scores on a scale Standard Deviation 1.1	0.0 Scores on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diabetes-Specific CBT (DS-CBT) n=93 Participants 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	Standard Diabetes Education n=88 Participants 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
Diabetes Acceptance (AADQ Score)	2.5 Scores on a scale Standard Deviation 7.7	2.0 Scores on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diabetes-Specific CBT (DS-CBT) n=93 Participants 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	Standard Diabetes Education n=88 Participants 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
Glycemic Control (HbA1c)	-0.5 %-points Standard Deviation 2.0	-0.7 %-points Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diabetes-Specific CBT (DS-CBT) n=93 Participants 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	Standard Diabetes Education n=88 Participants 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
Inflammatory Marker IL-6	0.0 pg/ml Interval -0.6 to 0.4	0.1 pg/ml Interval -0.6 to 0.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diabetes-Specific CBT (DS-CBT) n=93 Participants 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	Standard Diabetes Education n=88 Participants 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
Inflammatory Marker IL-1Ra	-100.5 pg/ml Interval to 28.8	-70.8 pg/ml Interval -171.8 to 11.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diabetes-Specific CBT (DS-CBT) n=93 Participants 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	Standard Diabetes Education n=88 Participants 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
Inflammatory Marker Hs-CRP	0.0 mg/dl Interval -0.1 to 0.2	0.0 mg/dl Interval -0.1 to 0.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diabetes-Specific CBT (DS-CBT) n=93 Participants 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	Standard Diabetes Education n=88 Participants 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
Health-care Costs: Health-care Utilisation	-2.2 number of medical appointment/half year Standard Deviation 15.4	-1.4 number of medical appointment/half year Standard Deviation 13.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diabetes-Specific CBT (DS-CBT) n=93 Participants 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	Standard Diabetes Education n=88 Participants 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
Health-care Costs: Non-productive Time	-2.2 number of days on sick leave/half year Standard Deviation 33.2	5.8 number of days on sick leave/half year Standard Deviation 30.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diabetes-Specific CBT (DS-CBT) n=93 Participants 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	Standard Diabetes Education n=88 Participants 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
Health-care Costs: Medication Intake	0.7 number of daily medications/half year Standard Deviation 1.6	0.8 number of daily medications/half year Standard Deviation 2.0

Adverse Events

Diabetes-Specific CBT (DS-CBT)

Serious events: 11 serious events

Other events: 28 other events

Deaths: 0 deaths

Standard Diabetes Education

Serious events: 21 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Diabetes-Specific CBT (DS-CBT) n=106 participants at risk 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	Standard Diabetes Education n=108 participants at risk 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
Gastrointestinal disorders Norwalk-Virus	2.8% 3/106	3.7% 4/108
Metabolism and nutrition disorders Severe Hypoglycaemia	2.8% 3/106	6.5% 7/108
Metabolism and nutrition disorders Ketoacidosis	1.9% 2/106	3.7% 4/108
General disorders New diagnosis of diabetes long-term complication	0.94% 1/106	2.8% 3/108
General disorders New diagnosis of cancer	1.9% 2/106	1.9% 2/108
General disorders Death	0.00% 0/106	0.93% 1/108

Other adverse events

Other adverse events
Measure	Diabetes-Specific CBT (DS-CBT) n=106 participants at risk 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	Standard Diabetes Education n=108 participants at risk 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
General disorders Nonsevere adverse event	26.4% 28/106	25.9% 28/108

Additional Information

Dr. Bernhard Kulzer

Research Institute of the Diabetes Academy Mergentheim

Phone: +49 7931

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place