NCT01009138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

November 26, 2015

Completed
Last Updated

October 6, 2022

Status Verified

September 1, 2022

Enrollment Period

2.3 years

First QC Date

November 5, 2009

Results QC Date

August 14, 2015

Last Update Submit

September 9, 2022

Conditions

Depressive SymptomsDiabetes Mellitus

Keywords

Subthreshold DepressionDiabetes-related DistressMinor DepressionLight affective DisorderSubclinical depressive SymptomsDiabetes mellitusLate ComplicationsMarkers of Inflammation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 12 month FU

Secondary Outcomes (11)

  • Quality of Life (EQ-5D TTO Score)

    Baseline,12 month FU

  • Diabetes-specific Distress (PAID Score)

    Baseline, 12 month FU

  • Diabetes Self-Care (SDSCA Score)

    Baseline, 12 month FU

  • Diabetes Acceptance (AADQ Score)

    Baseline, 12 month FU

  • Glycemic Control (HbA1c)

    Baseline, 12 month FU

  • +6 more secondary outcomes

Study Arms (2)

Diabetes-Specific CBT (DS-CBT)

EXPERIMENTAL

Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems

Behavioral: Diabetes-Specific CBT (DS-CBT)

Standard Diabetes Education

ACTIVE COMPARATOR

Standard Diabetes Education Lessons will be given to quantify the unspecific antidepressive Effects of Participation in Group Sessions with social Contact and Acquisition of Knowledge.

Behavioral: Standard Diabetes Education

Interventions

Diabetes-Specific CBT (DS-CBT)BEHAVIORAL

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

Also known as: Diabetes-Specific Cognitive-Behavioral Group Sessions
Diabetes-Specific CBT (DS-CBT)
Standard Diabetes EducationBEHAVIORAL

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

Also known as: Educative Group Lesson and Discussion
Standard Diabetes Education

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus
  • Elevated depressive symptoms (regarding to CES-D)
  • Age \>= 18 and \<=70
  • Sufficient German language skills
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forschungsinstitut der Diabetes Akademie Mergentheim e. V.

Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

Location

Related Publications (6)

  • Tulu S, Telci Caklili O, Alkaya G, Oguz A. Comment on Hermanns et al. The Effect of a Diabetes-Specific Cognitive Behavioral Treatment Program (DIAMOS) for Patients With Diabetes and Subclinical Depression: Results of a Randomized Controlled Trial. Diabetes Care 2015;38:551-560. Diabetes Care. 2016 Jan;39(1):e12. doi: 10.2337/dc15-1692. No abstract available.

    PMID: 26696661BACKGROUND

  • Hermanns N, Schmitt A, Reimer A, Ehrmann D, Haak T, Kulzer B. Response to Comment on Hermanns et al. The Effect of a Diabetes-Specific Cognitive Behavioral Treatment Program (DIAMOS) for Patients With Diabetes and Subclinical Depression: Results of a Randomized Controlled Trial. Diabetes Care 2015;38:551-560. Diabetes Care. 2016 Jan;39(1):e13-4. doi: 10.2337/dci15-0017. No abstract available.

    PMID: 26696662BACKGROUND

  • Hermanns N, Schmitt A, Gahr A, Herder C, Nowotny B, Roden M, Ohmann C, Kruse J, Haak T, Kulzer B. The effect of a Diabetes-Specific Cognitive Behavioral Treatment Program (DIAMOS) for patients with diabetes and subclinical depression: results of a randomized controlled trial. Diabetes Care. 2015 Apr;38(4):551-60. doi: 10.2337/dc14-1416. Epub 2015 Jan 20.

    PMID: 25605812RESULT

  • Reimer A, Schmitt A, Ehrmann D, Kulzer B, Hermanns N. Reduction of diabetes-related distress predicts improved depressive symptoms: A secondary analysis of the DIAMOS study. PLoS One. 2017 Jul 10;12(7):e0181218. doi: 10.1371/journal.pone.0181218. eCollection 2017.

    PMID: 28700718RESULT

  • Schmitt A, Reimer A, Ehrmann D, Kulzer B, Haak T, Hermanns N. Reduction of depressive symptoms predicts improved glycaemic control: Secondary results from the DIAMOS study. J Diabetes Complications. 2017 Nov;31(11):1608-1613. doi: 10.1016/j.jdiacomp.2017.08.004. Epub 2017 Aug 9.

    PMID: 28865713RESULT

  • Chernyak N, Kulzer B, Hermanns N, Schmitt A, Gahr A, Haak T, Kruse J, Ohmann C, Scheer M, Giani G, Icks A. Within-trial economic evaluation of diabetes-specific cognitive behaviour therapy in patients with type 2 diabetes and subthreshold depression. BMC Public Health. 2010 Oct 19;10:625. doi: 10.1186/1471-2458-10-625.

    PMID: 20959009DERIVED

MeSH Terms

Conditions

DepressionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Bernhard Kulzer
Organization
Research Institute of the Diabetes Academy Mergentheim
kulzer@diabetes-zentrum.de
+49 7931

Study Officials

  • Bernhard Kulzer, PhD

    Forschungsinstitut der Diabetes Akademie Mergentheim e. V.

    PRINCIPAL INVESTIGATOR

  • Norbert Hermanns, Prof., PhD

    Forschungsinstitut der Diabetes Akademie Mergentheim e. V.

    PRINCIPAL INVESTIGATOR

  • Thomas J Haak, Prof., MD

    Diabetes Zentrum Mergentheim; Forschungsinstitut der Diabetes Akademie Mergentheim e. V.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 6, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

October 6, 2022

Results First Posted

November 26, 2015

Record last verified: 2022-09

Locations

DE(1)