Digital Intervention for Depression and Anxiety in Adolescents

April 19, 2024 updated by: Adai Technology (Beijing) Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuang
      • Chengdu, Sichuang, China
        • Recruiting
        • West China hospital
        • Contact:
          • Liqun Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Health Education
Behavioral: Health Education
traditional health education app
Experimental: Digital Intervention
Behavioral: Digital Intervention
game-based digital intervention app

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adai Technology (Beijing) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pd003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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