DepressionNCT06423443
Digital Cognitive Behavioral Therapy for Depressive Disorders
A study testing Digital Cognitive Behavioral Therapy, Health Education and TAU in people with Depression and Anxiety, run by Adai Technology (Beijing) Co., Ltd..
Trial summary
This study aims to explore the effectiveness of digital interventions combined with medication in the treatment of patients with depressive disorders. Its main aim is to answer: Can digital interventions combined with medication effectively alleviate symptoms of depression? The experiment will compare the effects of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Digital Cognitive Behavioral Therapy, Health Education and TAU
- 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
- 20 Dec 2023to 30 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the diagnostic criteria for depression according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), without psychotic symptoms, as recurrent outpatient or inpatient.
- Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 22 before randomization.
- Age ≥ 18 and ≤ 65 years, regardless of gender.
- Understands the trial and signs the informed consent form.
Who cannot join
- Meets criteria for other psychiatric disorders according to the DSM-5, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression due to substance and/or medication or other medical conditions.
- History of substance and/or alcohol abuse within the past year.
- Significant risk of suicide (MADRS item 10 score = 4).
- Difficulty or inability to communicate verbally, understand or follow instructions, or cooperate with treatment and assessment.
- Inability to use a smartphone.
- Deemed unsuitable for participation by the researcher.
About this study
Official title: Digital Cognitive Behavioral Therapy for Depressive Disorders: A Randomized Controlled Trial
This study aims to explore the effectiveness of digital interventions combined with medication in the treatment of patients with depressive disorders. Its main aim is to answer: Can digital interventions combined with medication effectively alleviate symptoms of depression? The experiment will compare the effects of medication combined with digital interventions to those combined with online mental health education to evaluate their relative effectiveness. Participants will be required to engage with the medication plus digital therapy for a duration of two months, and follow-up assessments will be conducted to evaluate the long-term effects of the treatments and monitor any changes in depressive symptoms.
- Conditions
- Depression, Anxiety
- Being tested
- Digital Cognitive Behavioral Therapy, Health Education, TAU
- 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 Cognitive Behavioral TherapyBehavioural
digital cognitive behavioral therapy app
Health EducationBehavioural
traditional on-line health education app
TAUDrug
treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Digital Cognitive Behavioral Therapy | Experimental | Not described Receives: Behavioral: Digital Cognitive Behavioral Therapy; Drug: TAU |
| Health Education | Active comparator | Not described Receives: Behavioral: Health Education; Drug: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
Score Range: 0 (best outcome) to 60 (worst outcome) Higher scores indicate worse depression symptoms.
Measured: baseline and immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
Secondary outcomes (5)
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, and follow-ups at 4 weeks, 12 weeks, and 6 months
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, and follow-ups at 4 weeks, 12 weeks, and 6 months
Snaith-Hamilton Pleasure Scale (SHAPS)
Score Range: 14 (best outcome) to 56 (worst outcome) Higher scores indicate greater levels of anhedonia (reduced ability to experience pleasure).
Measured: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
Rumination Response Scale (RRS)
Score Range: 22 (best outcome) to 88 (worst outcome) Higher scores indicate higher levels of rumination.
Measured: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
Pittsburgh Sleep Quality Index (PSQI)
Score Range: 0 (best outcome) to 21 (worst outcome) Higher scores indicate poorer sleep quality.
Measured: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start20 Dec 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 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
- NCT06423443
- Sponsor's protocol ID
- ICBT2301
- Status last verified
- Oct 2026
- First submitted
- 16 May 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 Cognitive Behavioral Therapy for Depressive Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06423443
- Acronym / sponsor ID
- ICBT2301
- 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
- 20 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 May 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.
This study aims to explore the effectiveness of digital interventions combined with medication in the treatment of patients with depressive disorders. Its main aim is to answer: Can digital interventions combined with medication effectively alleviate symptoms of depression? The experiment will compare the effects of medication combined with digital interventions to those combined with online mental health education to evaluate their relative effectiveness. Participants will be required to engage with the medication plus digital therapy for a duration of two months, and follow-up assessments will be conducted to evaluate the long-term effects of the treatments and monitor any changes in depressive symptoms.
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 Cognitive Behavioral Therapy | Experimental | Behavioral: Digital Cognitive Behavioral Therapy, Drug: TAU |
| Health Education | Active comparator | Behavioral: Health Education, Drug: TAU |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets the diagnostic criteria for depression according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), without psychotic symptoms, as recurrent outpatient or inpatient.
- Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 22 before randomization.
- Age ≥ 18 and ≤ 65 years, regardless of gender.
- Understands the trial and signs the informed consent form.
Key exclusion criteria (6 listed)
- Meets criteria for other psychiatric disorders according to the DSM-5, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression due to substance and/or medication or other medical conditions.
- History of substance and/or alcohol abuse within the past year.
- Significant risk of suicide (MADRS item 10 score = 4).
- Difficulty or inability to communicate verbally, understand or follow instructions, or cooperate with treatment and assessment.
- Inability to use a smartphone.
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 Cognitive Behavioral Therapydigital cognitive behavioral therapy app | Behavioural | Digital Cognitive Behavioral Therapy |
| Health Educationtraditional on-line health education app | Behavioural | Health Education |
| TAUtreatment as usual | Drug | Digital Cognitive Behavioral Therapy, Health Education |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: baseline and immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
Score Range: 0 (best outcome) to 60 (worst outcome) Higher scores indicate worse depression symptoms.
5 secondary outcomes
PHQ-9 (Patient Health Questionnaire-9)
Time frame: baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months
GAD-7 (Generalized Anxiety Disorder-7)
Time frame: baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
Rumination Response Scale (RRS)
Time frame: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
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 Cognitive Behavioral Therapy, Health Education and TAU 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 6 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?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: baseline and immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months). 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.