Depression and Diabetes Control Trial

Not Applicable

• Conditions: Suboptimal glycaemic controlDiabetes-related distress; E14; F33.9; Unspecified diabetes mellitus; Recurrent depressive disorder, unspecified

• Registration Number: DRKS00011710
• Lead Sponsor: Forschungsinstitut der Diabetes-Akademie Bad Mergentheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-09
• Study Completion: 2018-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

Age between 18 and 70
- Diabetes mellitus type 1 or type 2
- Diabetes duration = 1 year
- Suboptimal glycaemic control (HbA1c > 7,5%)
- Elevated depressive symptoms (CES-D score = 16) and/or elevated diabetes distress (PAID score = 40)
- Sufficient language skills
- Written informed consent

Exclusion Criteria

- Severe major depressive disorder according to ICD-10
- Current psychiatric and/or psychotherapeutic treatment
- Current antidepressive medical treatment
- Suicidal ideation
- Acute mental disorder of the following type: schizophrenia or other psychotic disorder, bipolar disorder, severe eating disorder (anorexia nervosa, bulimia nervosa), substance use disorder
- History of personality disorder
- Severe somatic illnesses: dialysis-dependent nephropathy, acute cancer, severe heart disease (NYHA III - IV), severe neurologic illness (e. g. MS, dementia), severe autoimmune disease
- Terminal illness
- Bedriddenness
- Guardianship

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of glycaemic control as measured by the HbA1c [ Time Frame: 12 months ]<br>Mean difference between HbA1c values at baseline and at 12 month follow-up.