DepressionNCT06349993
Digital Intervention for Depression and Anxiety in Adolescents
A study testing Digital Intervention and Health Education in people with Depression and Anxiety, run by Adai Technology (Beijing) Co., Ltd..
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 and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2024to 1 Jul 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).
- having a HAMD(Hamilton Depression scale) score upon enrollment
- demonstrate normal cognitive function.
- voluntarily agree to participate in the study, and both they and their legal guardians must provide informed consent.
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)
- with concurrent psychiatric disorders (as determined by the assessing clinician)
- at high risk of suicide
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
- 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
| Study group | Role | What they receive |
|---|---|---|
| Digital Intervention | Experimental | Not described Receives: Behavioral: Digital Intervention |
| Health Education | Active comparator | Not described Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Score Range: 0 (best outcome) to 52 (worst outcome) Higher scores indicate worse depression symptoms.
Measured: baseline and immediately after 8-week intervention
Hamilton Anxiety Rating Scale
Score Range: 0 (best outcome) to 56 (worst outcome) Higher scores indicate more severe anxiety symptoms.
Measured: baseline and immediately after 8-week intervention
Secondary outcomes (3)
ADHD(attention deficit hyperactivity disorder) Rating Scale-IV
Score Range: 0 (best outcome) to 54 (worst outcome) Higher scores indicate more severe ADHD symptoms.
Measured: baseline and immediately after 8-week intervention
PHQ-9 (Patient Health Questionnaire-9)
PHQ-9 Score Range: 0 (best outcome) to 27 (worst outcome); higher scores indicate more severe depression symptoms.
Measured: baseline and weekly assessments during the treatment period, assessed up to 8 weeks
GAD-7 (Generalized Anxiety Disorder-7)
GAD-7 Score Range: 0 (best outcome) to 21 (worst outcome); higher scores indicate more severe generalized anxiety symptoms.
Measured: baseline and weekly assessments during the treatment period, assessed up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start17 Apr 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Why it stopped: The study was not initiated and was cancelled before any participants were enrolled.
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
- 0 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
- NCT06349993
- Sponsor's protocol ID
- pd003
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2024
- Last updated
- 29 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Intervention for Depression and Anxiety in Adolescents
- ClinicalTrials.gov ID
- NCT06349993
- Acronym / sponsor ID
- pd003
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not initiated and was cancelled before any participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Adai Technology (Beijing) Co., Ltd.University, hospital or other
- Study start
- 17 Apr 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 5 Apr 2024 (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
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Intervention | Experimental | Behavioral: Digital Intervention |
| Health Education | Active comparator | Behavioral: Health Education |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 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).
- having a HAMD(Hamilton Depression scale) score 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 (4 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)
- with concurrent psychiatric disorders (as determined by the assessing clinician)
- 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 | Digital Intervention |
| Health Educationtraditional health education app | Behavioural | Health Education |
Primary outcome
Hamilton Depression Rating Scale
Time frame: baseline and immediately after 8-week intervention
Score Range: 0 (best outcome) to 52 (worst outcome) Higher scores indicate worse depression symptoms.
Hamilton Anxiety Rating Scale
Time frame: baseline and immediately after 8-week intervention
Score Range: 0 (best outcome) to 56 (worst outcome) Higher scores indicate more severe anxiety symptoms.
3 secondary outcomes
ADHD(attention deficit hyperactivity disorder) Rating Scale-IV
Time frame: baseline and immediately after 8-week intervention
PHQ-9 (Patient Health Questionnaire-9)
Time frame: baseline and weekly assessments during the treatment period, assessed up to 8 weeks
GAD-7 (Generalized Anxiety Disorder-7)
Time frame: baseline and weekly assessments during the treatment period, assessed up to 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Intervention and Health Education in people with Depression and Anxiety, run by Adai Technology (Beijing) Co., Ltd..
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
Hamilton Depression Rating Scale (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 29 Oct 2026.