ClinicalTrials.gg
Status unknownNCT06349993Updated Apr 22, 2024

Digital Intervention for Depression and Anxiety in Adolescents

An interventional study of Digital Intervention and Health Education in Depression and Anxiety, sponsored by Adai Technology (Beijing) Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by Adai Technology (Beijing) Co., Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
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Study 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.

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Conditions studied

  • Depression
  • Anxiety
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In context

Depression

8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 100 is above the median of 84 across 6,869 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Adai Technology (Beijing) Co., Ltd. is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Digital Intervention

    Behavioral: Digital Intervention

  • Active comparator
    Health Education

    Behavioral: Health Education

Interventions

  • BehavioralDigital Intervention

    game-based digital intervention app

  • BehavioralHealth Education

    traditional health education app

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What researchers measure

Primary outcomes

  1. Hamilton Depression Rating Scale

    Score Range: 0 (best outcome) to 52 (worst outcome) Higher scores indicate worse depression symptoms.

    Time frame: baseline and immediately after 8-week intervention

  2. Hamilton Anxiety Rating Scale

    Score Range: 0 (best outcome) to 56 (worst outcome) Higher scores indicate more severe anxiety symptoms.

    Time frame: baseline and immediately after 8-week intervention

Secondary outcomes

  1. ADHD(attention deficit hyperactivity disorder) Rating Scale-IV

    Score Range: 0 (best outcome) to 54 (worst outcome) Higher scores indicate more severe ADHD symptoms.

    Time frame: baseline and immediately after 8-week intervention

  2. PHQ-9 (Patient Health Questionnaire-9)

    PHQ-9 Score Range: 0 (best outcome) to 27 (worst outcome); higher scores indicate more severe depression symptoms.

    Time frame: baseline and weekly assessments during the treatment period, assessed up to 8 weeks

  3. 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.

    Time frame: baseline and weekly assessments during the treatment period, assessed up to 8 weeks

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Study locations

1 of 1 sites recruiting
  • West China Hospital
    Chengdu, Sichuang, China
    • Liqun Zhang · Contact
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06349993
Lead sponsor
Adai Technology (Beijing) Co., Ltd.
Responsible party
Sponsor
First posted
Apr 5, 2024
Start date
Apr 17, 2024
Primary completion
Dec 30, 2024 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Apr 22, 2024

Study contacts

Liqun Zhang
Contact
zhangliqun@adai-tech.com
010-85795371

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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