Game-Based Digital Intervention for Depression in Adolescents

NCT ID: NCT06778785

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-17

Study Completion Date

2025-07-01

Brief Summary

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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

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Conditions

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Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Personalized Digital Intervention (Smartphone App-based)

Group Type EXPERIMENTAL

Digital Intervention

Intervention Type BEHAVIORAL

game-based digital intervention app

Personalization Algorithm

Intervention Type OTHER

a proprietary algorithm that adaptively adjust the treatment module and parameters to personalize the treatment regime

Health Education Placebo (Smartphone App-based)

Group Type PLACEBO_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

traditional health education app

Non-personalized Digital Intervention (Smartphone App-based)

Group Type ACTIVE_COMPARATOR

Digital Intervention

Intervention Type BEHAVIORAL

game-based digital intervention app

Interventions

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Digital Intervention

game-based digital intervention app

Intervention Type BEHAVIORAL

Health Education

traditional health education app

Intervention Type BEHAVIORAL

Personalization Algorithm

a proprietary algorithm that adaptively adjust the treatment module and parameters to personalize the treatment regime

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adai Technology (Beijing) Co., Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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West China Hospital

Chengdu, Sichuang, China

Site Status

Countries

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China

Other Identifiers

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pd2402

Identifier Type: -

Identifier Source: org_study_id

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