Game-Based Digital Intervention for Depression in Adolescents

February 14, 2025 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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

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 Locations

  • China
    • Sichuang
      • Chengdu, Sichuang, China
        • West China Hospital

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).
  • no prior use of antidepressants or antipsychotic medications.
  • having a HAMD (Hamilton Depression scale) score >= 8 upon enrollment
  • demonstrate normal cognitive function.
  • voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent.
  • being able to read and typeset Chinese.

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)
  • 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
Experimental: Personalized Digital Intervention (Smartphone App-based)
Behavioral: Digital Intervention
game-based digital intervention app
Other: Personalization Algorithm
a proprietary algorithm that adaptively adjust the treatment module and parameters to personalize the treatment regime
Placebo Comparator: Health Education Placebo (Smartphone App-based)
Behavioral: Health Education
traditional health education app
Active Comparator: Non-personalized Digital Intervention (Smartphone App-based)
Behavioral: Digital Intervention
game-based digital intervention app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Depression on the 50-point 16-item Hamilton Depression Rating Scale (HAM-D) at Week 8
Time Frame: baseline and immediately after 8-week intervention
HAM-D is a clinician-administered depression assessment scale. To adapt to adolescent participants, item 14 (genital symptoms) was removed. Thus, the score was calculated based on the 16 items. Possible scores range from 0 (no symptoms) to 50 (worst symptom). Change = (Week 8 Score - Baseline Score).
baseline and immediately after 8-week intervention
Response Rate - 50 Percent or Greater Reduction in the 50-point 16-item Hamilton Depression Rating Scale (HAM-D) at Week 8
Time Frame: baseline and immediately after 8-week intervention
HAM-D is a clinician-administered depression assessment scale. To adapt to adolescent participants, item 14 (genital symptoms) was removed. Thus, the score was calculated based on the 16 items. Possible scores range from 0 (no symptoms) to 50 (worst symptom). The response rate was defined as the number of participants with a 50% or greater reduction in HAM-D score from baseline to week 8.
baseline and immediately after 8-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in ADHD on the 54-point 18-item ADHD Rating Scale-IV
Time Frame: baseline and immediately after 8-week intervention
ADHD RS IV is a clinician-administered ADHD assessment scale. Possible scores range from 0 (no symptoms) to 50 (worst symptom). Change = (Week 8 Score - Baseline Score).
baseline and immediately after 8-week intervention
Change from Baseline in the 7-point Clinical Global Impressions-Severity Scale (CGI-S)
Time Frame: baseline and immediately after 8-week intervention
CGI-S is a clinician-administered symptom severity scale. Possible scores range from 1 (least severe) to 7 (most severe). Change = (Week 8 Score - Baseline Score).
baseline and immediately after 8-week intervention
Change from Baseline in the 88-point 22-item Ruminative Responses Scale (RRS)
Time Frame: baseline and immediately after 8-week intervention
Rumination is the process of compulsively focused attention on the symptoms of one's distress, and on its possible causes and consequences, as opposed to its solutions. RRS is a self-report scale that measures rumination. Possible scores range from 22 (least ruminative symptoms) to 88 (worst ruminative symptoms). Change = (Week 8 Score - Baseline Score).
baseline and immediately after 8-week intervention
Change from Baseline in the 35-point 5-item Satisfaction with Life Scale (SWLS)
Time Frame: baseline and immediately after 8-week intervention
The SWLS is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life. Possible scores range from 5 (lowest satisfaction) to 35 (highest satisfaction). Change = (Week 8 Score - Baseline Score).
baseline and immediately after 8-week intervention
The 7-point Clinical Global Impressions-Improvement Scale (CGI-I)
Time Frame: immediately after 8-week intervention
CGI-S is a clinician-administered total improvement scale. Possible scores range from 1 (very much improved) to 7 (Very much worse).
immediately after 8-week intervention
Change from Baseline in Anxiety on the 52-point 13-item Hamilton Anxiety Rating Scale (HAM-A) at Week 8
Time Frame: baseline and immediately after 8-week intervention
HAM-A is a clinician-administered anxiety assessment scale. To adapt to adolescent participants, item 12 (genitourinary symptoms) was removed. Thus, the score was calculated based on the 13 items. Possible scores range from 0 (no symptoms) to 52 (worst symptom). Change = (Week 8 Score - Baseline Score).
baseline and immediately after 8-week intervention
Response Rate - 50 Percent or Greater Reduction in the 52-point 13-item Hamilton Anxiety Rating Scale (HAM-A) at Week 8
Time Frame: baseline and immediately after 8-week intervention
HAM-A is a clinician-administered anxiety assessment scale. To adapt to adolescent participants, item 12 (genitourinary symptoms) was removed. Thus, the score was calculated based on the 13 items. Possible scores range from 0 (no symptoms) to 52 (worst symptom). Change = (Week 8 Score - Baseline Score). The response rate was defined as the number of participants with a 50% or greater reduction in HAM-D score from baseline to week 8.
baseline and immediately after 8-week intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Chinese Exam Score at Week 8.
Time Frame: baseline and immediately after 8-week intervention
The Chinese exam score was obtained by asking the participants the score (standardized to a 100-point scale) of their most recent exam on the subject of Chinese taken at school. Possible scores range from 0 (worst academic performance) to 100 (best academic performance). Change = (Week 8 Score - Baseline Score).
baseline and immediately after 8-week intervention
Change from Baseline in Math Exam Score at Week 8.
Time Frame: baseline and immediately after 8-week intervention
The Math exam score was obtained by asking the participants the score (standardized to a 100-point scale) of their most recent exam on the subject of Math taken at school. Possible scores range from 0 (worst academic performance) to 100 (best academic performance). Change = (Week 8 Score - Baseline Score).
baseline and immediately after 8-week intervention
Change from Baseline in English Exam Score at Week 8.
Time Frame: baseline and immediately after 8-week intervention
The English exam score was obtained by asking the participants the score (standardized to a 100-point scale) of their most recent exam on the subject of English taken at school. Possible scores range from 0 (worst academic performance) to 100 (best academic performance). Change = (Week 8 Score - Baseline Score).
baseline and immediately after 8-week intervention

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 (Actual)

December 30, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

January 12, 2025

First Submitted That Met QC Criteria

January 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pd2402

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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