Game-Based Digital Intervention for Depression in Adolescents

Adai Technology

Status: Active, not recruiting

Conditions: Depression; Anxiety

Treatments: Other: Personalization Algorithm; Behavioral: Digital Intervention; Behavioral: Health Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06778785

pd2402

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 3 patient groups, including a placebo group

Personalized Digital Intervention (Smartphone App-based)

Experimental group

Treatment:

Behavioral: Digital Intervention

Other: Personalization Algorithm

Health Education Placebo (Smartphone App-based)

Placebo Comparator group

Treatment:

Behavioral: Health Education

Non-personalized Digital Intervention (Smartphone App-based)

Active Comparator group

Treatment:

Behavioral: Digital Intervention