NCT01812291

Brief Summary

The study examines the efficacy of a stepped care approach for depressed diabetes patients (first study objective). 256 patients with diabetes and comorbid subthreshold or clinical depression will be randomly assigned to either a stepped care approach or a treatment-as-usual condition. The stepped care approach consists of three treatment steps comprising diabetes-specific cognitive-behavioral therapy (CBT) (group), depression-specific CBT (single), and psychotherapeutic and/or psychiatric treatment (single). Patients assigned to the stepped care approach will be treated stepwise until a clinically significant reduction of depressive symptoms is attained or all three treatment steps are passed. The primary outcome of the first study objective is a clinically significant reduction of depressive symptoms in the 12-month follow-up. Secondary outcomes are reduction of diabetes-related distress and improvement of well-being, health-related quality of life, diabetes acceptance, diabetes self-care, and glycaemic control. Additionally, cost-benefit analyses will be performed. The second study objective is to analyse associations between diabetes, depression, and the serum levels of inflammatory markers. The third study objective is to analyse the courses of depressive conditions in diabetes with regard to recovery rates and incidence of major depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable major-depressive-disorder

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

February 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

3.8 years

First QC Date

March 14, 2013

Last Update Submit

September 9, 2022

Conditions

Major Depressive DisorderMinor Depressive DisorderSub-Threshold DepressionDiabetes Mellitus

Keywords

Major DepressionMinor DepressionSub-Threshold DepressionAffective ConditionMood DisorderLight Affective DisorderSubclinical Depressive SymptomsDiabetes MellitusDiabetes-Related DistressSelf-Care BehaviourGlycaemic ControlInflammatory Markers

Outcome Measures

Primary Outcomes (1)

  • Depressive Mood - Hamilton Rating Scale for Depression (HAMD)

    Mean difference between HAMD scores at baseline and at 12 month follow up

    12 month

Secondary Outcomes (7)

  • Diabetes-Related Distress - The Problem Areas in Diabetes Questionnaire (PAID)

    12 months

  • Psychological/ Emotional Well-Being - The WHO-5 Well-being Index (WHO-5)

    12 month

  • Health-Related Quality of Life - The Short Form-36 Health Survey (SF-36)

    12 month

  • Diabetes Self-Care Behavior - The Summary of Diabetes Self-Care Activities Measure (SDSCA)

    12 month

  • Glycaemic Control (HbA1c)

    12 month

  • +2 more secondary outcomes

Other Outcomes (2)

  • Inflammatory Markers

    Baseline, 12 month follow up

  • Major Depressive Disorder

    12 months

Study Arms (2)

Stepped Care Approach for Depression

EXPERIMENTAL

Step 1: Diabetes-Specific CBT (5 group sessions) Step 2: Depression-Specific CBT (6 single sessions) Step 3: Referral to Psychotherapist and/or Psychiatrist

Behavioral: Step 1: Diabetes-Specific CBT (5 group sessions)Behavioral: Step 2: Depression-Specific CBT (6 single sessions)Behavioral: Step 3: Referral to Psychotherapist and/or Psychiatrist

Treatment-as-usual

ACTIVE COMPARATOR

Standard Diabetes Education

Behavioral: Standard Diabetes Education

Interventions

Step 1: Diabetes-Specific CBT (5 group sessions)BEHAVIORAL

Diabetes-Specific CBT (5 group sessions) focusing on diabetes-related problems and distress ('DIAMOS - Strengthening Diabetes Motivation'). Includes: * Diabetes problem analysis/ definition * Diabetes problem solving intervention * Cognitive restructuring of diabetes problems * Activation of personal and social resources * Goal definition and agreement

Stepped Care Approach for Depression
Step 2: Depression-Specific CBT (6 single sessions)BEHAVIORAL

Depression-Specific CBT (6 single sessions) focusing on depressive cognitions and affective problems (manualised). Includes: * Functional explanatory model of depression * Cognitive restructuring of negative thoughts * Practice of alternative beneficial thoughts * Specific cognitive interventions regarding self-criticism, guilt, low self-esteem, fear, and inactivity.

Stepped Care Approach for Depression
Step 3: Referral to Psychotherapist and/or PsychiatristBEHAVIORAL

Non-responders to previous treatment steps will be referred to an psychotherapist and/or psychiatrist for intensified treatment. Treatments procedures will be monitored and interventions will be scored to enable the evaluation of treatment effects.

Stepped Care Approach for Depression
Standard Diabetes EducationBEHAVIORAL

Standard diabetes education and professional care. Includes: * Health care and specific topics (e. g. blood pressure) * Diabetes complications * Healthy and unhealthy foods, cooking recommendations and recipes * Foot care: exercises, care and control, injuries, and diabetic neuropathy * Sports, activities and exercise * Social aspects of living with diabetes

Treatment-as-usual

Eligibility Criteria

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

You may qualify if:

  • Age \>=18 and \<=70
  • Diabetes mellitus
  • Elevated depressive symptoms (CES-D score \>=16) and/or elevated diabetes-related distress (PAID score \>=40)
  • Sufficient language skills (German)
  • Written informed consent

You may not qualify if:

  • Severe depressive episode (F32.2/ F32.3)
  • Current psychotherapeutic/ psychiatric treatment
  • Current antidepressive medication
  • Suicidal intention
  • Current schizophrenia/ psychotic disorder, specified eating disorder, bipolar disorder, addictive disorder, personality disorder
  • Severe physical illness (i.e. cancer, multiple sclerosis, dementia)
  • Terminal illness
  • Bedriddenness
  • Guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forschungsinstitut der Diabetes Akademie Mergentheim e. V.

Bad Mergentheim, Baden-Wurttemberg, D-97980, Germany

Location

Related Publications (5)

  • Schmitt A, Kulzer B, Ehrmann D, Haak T, Hermanns N. Diabetes Distress and Depression during COVID-19: Response to Breznoscakova et al. Uncovering the Untold Emotional Toll of Living with Diabetes in the COVID-19 Era. Psychother Psychosom. 2022;91(4):288-289. doi: 10.1159/000524602. Epub 2022 May 6. No abstract available.

    PMID: 35526518BACKGROUND

  • Schmitt A, Kulzer B, Reimer A, Herder C, Roden M, Haak T, Hermanns N. Evaluation of a Stepped Care Approach to Manage Depression and Diabetes Distress in Patients with Type 1 Diabetes and Type 2 Diabetes: Results of a Randomized Controlled Trial (ECCE HOMO Study). Psychother Psychosom. 2022;91(2):107-122. doi: 10.1159/000520319. Epub 2021 Dec 7.

    PMID: 34875666RESULT

  • Herder C, Schmitt A, Budden F, Reimer A, Kulzer B, Roden M, Haak T, Hermanns N. Association between pro- and anti-inflammatory cytokines and depressive symptoms in patients with diabetes-potential differences by diabetes type and depression scores. Transl Psychiatry. 2018 Mar 9;7(11):1. doi: 10.1038/s41398-017-0009-2.

    PMID: 29520075RESULT

  • Herder C, Schmitt A, Budden F, Reimer A, Kulzer B, Roden M, Haak T, Hermanns N. Longitudinal associations between biomarkers of inflammation and changes in depressive symptoms in patients with type 1 and type 2 diabetes. Psychoneuroendocrinology. 2018 May;91:216-225. doi: 10.1016/j.psyneuen.2018.02.032. Epub 2018 Mar 6.

    PMID: 29525039RESULT

  • Schmitt A, Reimer A, Kulzer B, Haak T, Gahr A, Hermanns N. Assessment of diabetes acceptance can help identify patients with ineffective diabetes self-care and poor diabetes control. Diabet Med. 2014 Nov;31(11):1446-51. doi: 10.1111/dme.12553. Epub 2014 Aug 2.

    PMID: 25047992DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDiabetes MellitusMood Disorders

Condition Hierarchy (Ancestors)

Depressive DisorderMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bernhard Kulzer, PD Dr.

    Forschungsinstitut der Diabetes Akademie Mergentheim

    PRINCIPAL INVESTIGATOR

  • Norbert Hermanns, Prof. Dr.

    Forschungsinstitut der Diabetes Akademie Mergentheim

    PRINCIPAL INVESTIGATOR

  • Thomas Haak, Prof. Dr.

    Forschungsinstitut der Diabetes Akademie Mergentheim

    STUDY DIRECTOR

  • Johannes Kruse, Prof. Dr.

    University of Giessen

    PRINCIPAL INVESTIGATOR

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
PhD

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 18, 2013

Study Start

February 1, 2012

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations

DE(1)