Clinical trial NCT06778785: Game-Based Digital Intervention for Depression in Adolescents
Official title: Game-Based Digital Intervention for Depression in Adolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Adai Technology (Beijing) Co., Ltd.
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 450
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Depression on the 50-point 16-item Hamilton Depression Rating Scale (HAM-D) at Week 8
timeFrame: baseline and immediately after 8-week intervention
measure: Response Rate - 50 Percent or Greater Reduction in the 50-point 16-item Hamilton Depression Rating Scale (HAM-D) at Week 8
timeFrame: baseline and immediately after 8-week intervention
Secondary outcomes:
measure: Change from Baseline in ADHD on the 54-point 18-item ADHD Rating Scale-IV
timeFrame: baseline and immediately after 8-week intervention
measure: Change from Baseline in the 7-point Clinical Global Impressions-Severity Scale (CGI-S)
timeFrame: baseline and immediately after 8-week intervention
measure: Change from Baseline in the 88-point 22-item Ruminative Responses Scale (RRS)
timeFrame: baseline and immediately after 8-week intervention
measure: Change from Baseline in the 35-point 5-item Satisfaction with Life Scale (SWLS)
timeFrame: baseline and immediately after 8-week intervention
measure: The 7-point Clinical Global Impressions-Improvement Scale (CGI-I)
timeFrame: immediately after 8-week intervention
measure: Change from Baseline in Anxiety on the 52-point 13-item Hamilton Anxiety Rating Scale (HAM-A) at Week 8
timeFrame: baseline and immediately after 8-week intervention
measure: Response Rate - 50 Percent or Greater Reduction in the 52-point 13-item Hamilton Anxiety Rating Scale (HAM-A) at Week 8
timeFrame: baseline and immediately after 8-week intervention
Other outcomes:
measure: Change from Baseline in Chinese Exam Score at Week 8.
timeFrame: baseline and immediately after 8-week intervention
measure: Change from Baseline in Math Exam Score at Week 8.
timeFrame: baseline and immediately after 8-week intervention
measure: Change from Baseline in English Exam Score at Week 8.
timeFrame: baseline and immediately after 8-week intervention
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuang
Study officials:
References: