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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06349993
Other study ID # pd003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 17, 2024
Est. completion date July 1, 2025

Study information

Verified date April 2024
Source Adai Technology (Beijing) Co., Ltd.
Contact Liqun Zhang
Phone 010-85795371
Email zhangliqun@adai-tech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy. Participants will be asked to engage with the digital intervention platform for a period of two months.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 1, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years to 18 Years
Eligibility Inclusion Criteria: - The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) will be used to assess participants' eligibility based on the diagnostic criteria for depression outlined in the DSM-5(the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition). - having a HAMD(Hamilton Depression scale) score upon enrollment - demonstrate normal cognitive function. - voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent. Exclusion Criteria: - with severe consciousness disorders and a history of psychiatric illness, traumatic brain injury, substance dependence, or acute poisoning - with concurrent psychiatric disorders (as determined by clinical assessment) - with concurrent psychiatric disorders (as determined by the assessing clinician) - at high risk of suicide

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Digital Intervention
game-based digital intervention app
Health Education
traditional health education app

Locations

Country Name City State
China West China Hospital Chengdu Sichuang

Sponsors (1)

Lead Sponsor Collaborator
Adai Technology (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Depression Rating Scale Score Range: 0 (best outcome) to 52 (worst outcome) Higher scores indicate worse depression symptoms. baseline and immediately after 8-week intervention
Primary Hamilton Anxiety Rating Scale Score Range: 0 (best outcome) to 56 (worst outcome) Higher scores indicate more severe anxiety symptoms. baseline and immediately after 8-week intervention
Secondary ADHD(attention deficit hyperactivity disorder) Rating Scale-IV Score Range: 0 (best outcome) to 54 (worst outcome) Higher scores indicate more severe ADHD symptoms. baseline and immediately after 8-week intervention
Secondary PHQ-9 (Patient Health Questionnaire-9) PHQ-9 Score Range: 0 (best outcome) to 27 (worst outcome); higher scores indicate more severe depression symptoms. baseline and weekly assessments during the treatment period, assessed up to 8 weeks
Secondary GAD-7 (Generalized Anxiety Disorder-7) GAD-7 Score Range: 0 (best outcome) to 21 (worst outcome); higher scores indicate more severe generalized anxiety symptoms. baseline and weekly assessments during the treatment period, assessed up to 8 weeks
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