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:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT05865834
Eligibility Criteria:
Inclusion Criteria:
* Registered secondary schools with the Board of Secondary Education Karachi who will provide consent to participate in the study
* 12-18-year-olds adolescents enrolled in public and private school of Karachi Pakistani
* The intervention and control arm must understand English or Urdu in order to use the mobile-based application.
* Intervention group must have access to a smartphone or portable smart device (Electronic Tablets, iPad, etc.).
* Participants having access to Wi-Fi at home- or on the phone for downloading the app.
* Parenteral consent is required for an adolescent to participate in this study; simultaneously, an individual's consent is equally important to be included in this trial.
* Moreover, students will be asked to participate in the study if they:(a) experience mild to moderate depression defined as scoring above the cut-off score of 4 on the Patient Health Questionnaire for adolescents (PHQ-A) and/or anxiety symptoms defined as scoring above the cut-off score of 5 on the Generalized Anxiety Disorder scale-7 items (GAD-7 (b) had a well-being score of ≤50 on World Health Organization Well-Being scale (WHO-5) at basic screening level.
Exclusion Criteria:
* School authorities who did not grant permission to conduct the research study in their school
* School unable or unwilling to provide informed consent /assent
* students not willing to participate in the study
* Use of a mobile device that does not comply with the app requirements (non- android phone holders)
* Have no internet access or smartphone
* Students will be excluded if they: (a) any chronic disease (c) currently taking psychiatric consultation/ treatment for depression/ anxiety, or have received treatment/therapy in the past 12 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT05865834
Study Brief:
Protocol Section:
NCT05865834