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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT06320756
Eligibility Criteria:
Inclusion Criteria:
* Age between 13-25 years
* Diagnosis of Type1 diabetes
* Access to a smartphone with internet connection
* Can read and understand Hindi
* Mental health distress as demonstrated by elevated scores on any of the scales: Mild -moderate symptoms (between 5-14 score) on Patient Health Questionnaire (PHQ-9), moderate and above diabetes distress (mean score 2.0 and higher) on the Diabetes Distress Scale (DDS-17)
Exclusion Criteria:
* Do not own or have access to a mobile device
* Are identified to have risk of harm/ suicidality (as identified on PHQ-9)
* Are currently undergoing or have received psychiatric support
* Experience any mental or physical impairments that create accessibility barriers to the use of a smartphone or access to a digital mental health intervention
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
25 Years
Study:
NCT06320756
Study Brief:
Protocol Section:
NCT06320756