Digital Intervention for Depression and Anxiety in Adolescents

Not Applicable

Recruiting

• Conditions: Anxiety; Depression
• Interventions: Behavioral: Digital Intervention; Behavioral: Health Education

• Registration Number: NCT06349993
• Lead Sponsor: Adai Technology (Beijing) Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-25
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-05
• Study Start: 2024-04-17
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2024-12-30
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Intervention	Digital Intervention	-
Health Education	Health Education	-

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale	baseline and immediately after 8-week intervention	Score Range: 0 (best outcome) to 56 (worst outcome) Higher scores indicate more severe anxiety symptoms.
Hamilton Depression Rating Scale	baseline and immediately after 8-week intervention	Score Range: 0 (best outcome) to 52 (worst outcome) Higher scores indicate worse depression symptoms.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuang, China