Digital Intervention for Depression and Anxiety in Adolescents

Depression Clinical Trial

Official title:

Digital Intervention for Depression and Anxiety in Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06349993
• Other study ID #: pd003
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

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