DepressionNCT06778785
Game-Based Digital Intervention for Depression in Adolescents
A study testing Digital Intervention, Health Education and Personalization Algorithm in people with Depression and Anxiety, run by Adai Technology (Beijing) Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Digital Intervention, Health Education and Personalization Algorithm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression, Anxiety
- Being tested
- Digital Intervention, Health Education, Personalization Algorithm
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital InterventionBehavioural
game-based digital intervention app
Health EducationBehavioural
traditional health education app
Personalization AlgorithmOther
a proprietary algorithm that adaptively adjust the treatment module and parameters to personalize the treatment regime
| Study group | Role | What they receive |
|---|---|---|
| Personalized Digital Intervention (Smartphone App-based) | Experimental | Not described Receives: Behavioral: Digital Intervention; Other: Personalization Algorithm |
| Health Education Placebo (Smartphone App-based) | Placebo comparator | Not described Receives: Behavioral: Health Education |
| Non-personalized Digital Intervention (Smartphone App-based) | Active comparator | Not described Receives: Behavioral: Digital Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: baseline and immediately after 8-week intervention
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: baseline and immediately after 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start17 Apr 2024
- Primary completion30 Dec 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adai Technology (Beijing) Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778785
- Sponsor's protocol ID
- pd2402
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Game-Based Digital Intervention for Depression in Adolescents
- ClinicalTrials.gov ID
- NCT06778785
- Acronym / sponsor ID
- pd2402
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Adai Technology (Beijing) Co., Ltd.University, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized Digital Intervention (Smartphone App-based) | Experimental | Behavioral: Digital Intervention, Other: Personalization Algorithm |
| Health Education Placebo (Smartphone App-based) | Placebo comparator | Behavioral: Health Education |
| Non-personalized Digital Intervention (Smartphone App-based) | Active comparator | Behavioral: Digital Intervention |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Interventiongame-based digital intervention app | Behavioural | Non-personalized Digital Intervention (Smartphone App-based), Personalized Digital Intervention (Smartphone App-based) |
| Health Educationtraditional health education app | Behavioural | Health Education Placebo (Smartphone App-based) |
| Personalization Algorithma proprietary algorithm that adaptively adjust the treatment module and parameters to personalize the treatment regime | Other | Personalized Digital Intervention (Smartphone App-based) |
Primary outcome
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).
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.
7 secondary outcomes
Change from Baseline in ADHD on the 54-point 18-item ADHD Rating Scale-IV
Time frame: 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
Change from Baseline in the 88-point 22-item Ruminative Responses Scale (RRS)
Time frame: 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 7-point Clinical Global Impressions-Improvement Scale (CGI-I)
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
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
Time frame: baseline and immediately after 8-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Intervention, Health Education and Personalization Algorithm in people with Depression and Anxiety, run by Adai Technology (Beijing) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.