Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT02675257
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02675257
Study Brief:
Protocol Section:
NCT02675257