An interventional study of Digital Intervention and Health Education in Depression and Anxiety, sponsored by Adai Technology (Beijing) Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Adai Technology (Beijing) Co., Ltd. · Not applicable, Interventional, and Treatment
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.
8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 450 is above the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →Adai Technology (Beijing) Co., Ltd. is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Behavioral: Digital Intervention · Other: Personalization Algorithm
Behavioral: Health Education
Behavioral: Digital Intervention
game-based digital intervention app
traditional health education app
a proprietary algorithm that adaptively adjust the treatment module and parameters to personalize the treatment regime
Change from Baseline in Depression on the 50-point 16-item Hamilton Depression Rating Scale (HAM-D) at Week 8
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).
Time frame: 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
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.
Time frame: baseline and immediately after 8-week intervention
Change from Baseline in ADHD on the 54-point 18-item ADHD Rating Scale-IV
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).
Time frame: baseline and immediately after 8-week intervention
Change from Baseline in the 7-point Clinical Global Impressions-Severity Scale (CGI-S)
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).
Time frame: baseline and immediately after 8-week intervention
Change from Baseline in the 88-point 22-item Ruminative Responses Scale (RRS)
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).
Time frame: baseline and immediately after 8-week intervention
Change from Baseline in the 35-point 5-item Satisfaction with Life Scale (SWLS)
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).
Time frame: baseline and immediately after 8-week intervention
The 7-point Clinical Global Impressions-Improvement Scale (CGI-I)
CGI-S is a clinician-administered total improvement scale. Possible scores range from 1 (very much improved) to 7 (Very much worse).
Time frame: 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
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).
Time frame: 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
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.
Time frame: baseline and immediately after 8-week intervention
Change from Baseline in Chinese Exam Score at Week 8.
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).
Time frame: baseline and immediately after 8-week intervention
Change from Baseline in Math Exam Score at Week 8.
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).
Time frame: baseline and immediately after 8-week intervention
Change from Baseline in English Exam Score at Week 8.
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).
Time frame: baseline and immediately after 8-week intervention
Ran from Apr 2024 to primary completion in Dec 2024, 8 months.
Of 3,016 non-industry interventional studies with no phase under Depression, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 8 months is below that.
Counting every sponsor, half of 3,112 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Adai Technology (Beijing) Co., Ltd.