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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT03473704
Eligibility Criteria:
Inclusion Criteria:
* Have a medical diagnosis of type 1 diabetes ≥1 year;
* be over 18 years old;
* have a psychological diagnosis of mild / moderate major depressive disorder, dysthymia or depressive symptomatology;
* not have a concomitant pharmacological treatment that could modify the glycaemia values or the depressive symptomatology;
* not be in previous psychological treatment;
* absence of:
* chronic renal failure,
* impaired liver function tests,
* active thyroid disease (except correctly substituted hypothyroidism),
* gestation in progress;
* absence of acute ketosis decompensation at the beginning of the study;
* have access to the internet.
Exclusion Criteria:
* Type 2 diabetes;
* pregnant women or planning pregnancy;
* severe macro or microvascular complications;
* diagnosis of severe major depressive disorder with suicide risk;
* no collaboration (no informed consent signature);
* not have access to the internet;
* present a disabling psychiatric disorder, psychosis, diagnosis of severe depressive disorder, suicidal ideation;
* not have access to the internet.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03473704
Study Brief:
Protocol Section:
NCT03473704