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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT02027259
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 2 diabetes
* Clinical diagnosis of depression
* PHQ-9 score ≥10 for depressive symptoms
* \>= 18 years old
* a most recent HbA1c ≥8.0% within the previous 12 months in the chart; and
* have 1 or more of the following modifiable CVD risk factors not at target goals, defined as:
* current smoker (any cigarette smoking \<30 days),
* blood pressure \>130/80 mm Hg, documented at least twice in the last 6 months
* LDL cholesterol \>100 mg/dL within the last 12 months.
Exclusion Criteria:
* Inability to attend the group sessions
* active psychosis of any type or organic brain injury that precludes DM self- care
* type 1 diabetes as documented in the medical chart
* pregnancy
* actively suicidal and /or
* end-stage medical illness (e.g. metastatic cancer, awaiting organ transplant)
* Patients currently enrolled in DM group programs that include medication titration within the group setting would not be eligible due to co- intervention.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02027259
Study Brief:
Protocol Section:
NCT02027259