Evaluation of a Stepped Care Approach to Manage Depression in Diabetes

NACompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Major Depressive DisorderMinor Depressive DisorderSub-Threshold DepressionDiabetes Mellitus
Interventions
BEHAVIORAL

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

"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"

BEHAVIORAL

Step 2: Depression-Specific CBT (6 single sessions)

"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."

BEHAVIORAL

Step 3: Referral to Psychotherapist and/or Psychiatrist

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.

BEHAVIORAL

Standard Diabetes Education

"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"

Trial Locations (1)

D-97980

Forschungsinstitut der Diabetes Akademie Mergentheim e. V., Bad Mergentheim

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

German Federal Ministry of Education and Research

OTHER_GOV

collaborator

German Diabetes Center

OTHER

collaborator

Heinrich-Heine University, Duesseldorf

OTHER

collaborator

University of Giessen

OTHER

collaborator

Helmholtz Zentrum München

INDUSTRY

collaborator

Coordination Center for Clinical Trials (KKS)

UNKNOWN

lead

Forschungsinstitut der Diabetes Akademie Mergentheim

OTHER

NCT01812291 - Evaluation of a Stepped Care Approach to Manage Depression in Diabetes | Biotech Hunter | Biotech Hunter