DepressionNCT06831435
Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study
A study testing a digital product based on CBT in people with Depression and Bipolar Affective Disorder, run by Peking University at 1 site in China.
Trial summary
The project proposes to develop a digital product based on cognitive behavioral therapy for the assisted treatment of depression. The digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Depression, Bipolar Affective Disorder, Schizophenia Disorder
- What is being tested?
- a digital product based on CBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 14-60 years (including 14 and 60), no gender restriction;
- HAMD >= 14;
- Written informed consent obtained from the patient; written informed consent obtained from the guardian for minors.
Who cannot join
- Persons with severe suicidal tendencies (item 10 of the MADRS scale ≥ 5).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Sixth Hostipal
Beijing, Beijing Municipality, 100191
Weihua Yue, 86-010-82805307, dryue@bjmu.edu.cn
About this study
The project proposes to develop a digital product based on cognitive behavioral therapy for the assisted treatment of depression. The digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. The therapy is developed by psychotherapists, which is conducted for a total of 8 weeks, with weekly sessions including AI-guided course work and homework. This study aims to evaluate the therapeutic effects of CBT-based digital products for depression in patients through a real-world study, and to explore its genetic and neuroimaging mechanisms.
- Conditions
- Depression, Bipolar Affective Disorder, Schizophenia Disorder, Psychiatric &Amp;or Mood Disorder
- Being tested
- a digital product based on CBT
- Keywords
- i-CBT, a real-world study
- Medical subject headings
- Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a digital product based on CBTDevice
The digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. The therapy is developed by psychotherapists, which is conducted for a total of 8 weeks, with weekly sessions including Al-guided course work and homework.
| Study group | Role | What they receive |
|---|---|---|
| i-CBT group | Experimental | i-CBT combined with conventional drug treatment Receives: Device: a digital product based on CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hamilton Depression Rating Scale (HAMD)
The outcome is assessed by 17-item Hamilton Depression Rating Scale (HAMD-17) Scale. Total HAMD scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. The change of HAMD from baseline to 8-week (after intervention) was used as the primary outcome.
Measured: Week 4 and 8 of treatment duration
Secondary outcomes (13)
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
The outcome is assessed by Montgomery-Asberg Depression Rating Scale (MADRS). Total MADRS score ranges from 0 to 60, with higher scores indicating greater severity of depression. The change of MADRS from baseline to 8-week (after intervention) was used.
Measured: Week 4 and 8 of treatment duration
Change from baseline in Positive and Negative Syndrome Scale (PANSS)
The outcome is assessed by the Positive and Negative Syndrome Scale (PANSS). The PANSS consists of 30 items, divided into three subscales: Positive Symptoms (7 items), Negative Symptoms (7 items), and General Psychopathology (16 items). Each item is rated on a 7-point scale from 1 (absent) to 7 (extreme), with higher scores indicating more severe symptoms. The total PANSS score ranges from 30 to 210, with higher scores reflecting greater symptom severity.
Measured: Week 4 and 8 of treatment duration
Response to treatment
Reduction rate of Hamilton Depression Scale (HAMD-17) or Montgomery-Asberg Depression Rating Scale (MADRS) score ≥50% was recognized as response to treatment.
Measured: Week 4 and 8 of treatment duration
Clinical Global Impression-Severity of Illness (CGI-S)
The outcome was assessed by the Clinical Global Impression-Severity of Illness (CGI-S) scale. It is rated on a 7-point scale. Higher scores indicate more severe symptoms.
Measured: Week 4 and 8 of treatment duration
Change from baseline in Hamilton Anxiety Rating Scale (HAMA)
The outcome is assessed by 14-item Hamilton Anxiety Scale (HAMA). Total score ranges from 0 to 56, with higher scores indicating greater severity of anxiety. The change of HAMA from baseline to 8-week (after intervention) was used.
Measured: Week 4 and 8 of treatment duration
Change from baseline in Ruminative Responses Scale (RRS)
This outcome is assessed by Ruminative Responses Scale (RRS). Total score ranges from 22 to 88, with higher scores indicating greater severity of rumination. The change of RRS from baseline to 8-week (after intervention) was used.
Measured: Week 4 and 8 of treatment duration
Change from baseline in Pittsburgh Sleep Quality Index (PSQI)
This outcome is assessed by Pittsburgh Sleep Quality Index (PSQI). Total score ranges from 0 to 21, with higher scores indicating greater severity of sleep problems. The change of PSQI from baseline to 8-week (after intervention) was used.
Measured: Week 4 and 8 of treatment duration
Change from baseline in Connor-Davidson Resilience Scale (CD-RISC)
This outcome is assessed by Connor-Davidson Resilience Scale (CD-RISC). Total score ranges from 0 to 100, with higher scores indicating greater resilience. The change of CD-RISC from baseline to 8-week (after intervention) was used.
Measured: Week 4 and 8 of treatment duration
Change from baseline in Thinc-Integrated Tool(THINC-it)
Cognitive function was assessed by Thinc-Integrated Tool(THINC-it) using digital device. The change of THINC-it from baseline to 8-week (after intervention) was used.
Measured: Week 8 of treatment duration
Mood Disorder Questionnaire (MDQ)
This outcome is assessed by Mood Disorder Questionnaire (MDQ), which is used to assess the positive symptom of bipolar. A positive screening for bipolar disorder is determined when there are ≥7 of the 13 screening symptoms present, at least one "yes" response in the second section indicating the co-occurrence of several symptoms, and a severity level of "moderate" or "serious problem" in the third section.
Measured: Week 4 and 8 of treatment duration
Rating Scale for Side Effects（SERS）
This outcome is assessed by Rating Scale for Side Effects (SERS), which assess 13 side-effects. Total score ranges from 13 to 52, with higher scores indicating more side-effects.
Measured: Week 4 and 8 of treatment duration
Client Satisfaction Questionnaire-3 （CSQ-3)
User's satisfaction was assessed by Client Satisfaction Questionnaire-3 （CSQ-3). Total score ranges from 3 to 12. with higher scores indicating greater satisfaction.
Measured: Week 8 of treatment duration
Change from baseline in Young Mania Rating Scale (YMRS)
The outcome is assessed by the Young Mania Rating Scale (YMRS). The YMRS consists of 11 items that assess the severity of manic symptoms, including mood, speech, motor activity, sexual interest, sleep, and other behaviors. Each item is rated on a scale from 0 to 4, with higher scores indicating greater severity of manic symptoms. The total YMRS score can range from 0 to 44, with higher scores reflecting more severe mania.
Measured: Week 4 and 8 of treatment duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start13 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihua Yue, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831435
- Sponsor's protocol ID
- 2024-83
- Status last verified
- Dec 2025
- First submitted
- 12 Feb 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study
- ClinicalTrials.gov ID
- NCT06831435
- Acronym / sponsor ID
- 2024-83
- Conditions
- Depression, Bipolar Affective Disorder, Schizophenia Disorder, Psychiatric &Amp;or Mood Disorder
- Keywords
- i-CBT, a real-world study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 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 project proposes to develop a digital product based on cognitive behavioral therapy for the assisted treatment of depression. The digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. The therapy is developed by psychotherapists, which is conducted for a total of 8 weeks, with weekly sessions including AI-guided course work and homework. This study aims to evaluate the therapeutic effects of CBT-based digital products for depression in patients through a real-world study, and to explore its genetic and neuroimaging mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| i-CBT group | Experimental | Device: a digital product based on CBTi-CBT combined with conventional drug treatment |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 14-60 years (including 14 and 60), no gender restriction;
- HAMD >= 14;
- Written informed consent obtained from the patient; written informed consent obtained from the guardian for minors.
Key exclusion criteria (1 listed)
- Persons with severe suicidal tendencies (item 10 of the MADRS scale ≥ 5).
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 |
|---|---|---|
| a digital product based on CBTThe digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. The therapy is developed by psychotherapists, which is conducted for a total of 8 weeks, with weekly sessions including Al-guided course work and homework. | Device | i-CBT group |
Primary outcome
Change from baseline in Hamilton Depression Rating Scale (HAMD)
Time frame: Week 4 and 8 of treatment duration
The outcome is assessed by 17-item Hamilton Depression Rating Scale (HAMD-17) Scale. Total HAMD scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. The change of HAMD from baseline to 8-week (after intervention) was used as the primary outcome.
13 secondary outcomes
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Week 4 and 8 of treatment duration
Change from baseline in Positive and Negative Syndrome Scale (PANSS)
Time frame: Week 4 and 8 of treatment duration
Response to treatment
Time frame: Week 4 and 8 of treatment duration
Clinical Global Impression-Severity of Illness (CGI-S)
Time frame: Week 4 and 8 of treatment duration
Change from baseline in Hamilton Anxiety Rating Scale (HAMA)
Time frame: Week 4 and 8 of treatment duration
Change from baseline in Ruminative Responses Scale (RRS)
Time frame: Week 4 and 8 of treatment duration
Change from baseline in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 4 and 8 of treatment duration
Change from baseline in Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Week 4 and 8 of treatment duration
Change from baseline in Thinc-Integrated Tool(THINC-it)
Time frame: Week 8 of treatment duration
Mood Disorder Questionnaire (MDQ)
Time frame: Week 4 and 8 of treatment duration
Rating Scale for Side Effects（SERS）
Time frame: Week 4 and 8 of treatment duration
Client Satisfaction Questionnaire-3 （CSQ-3)
Time frame: Week 8 of treatment duration
Change from baseline in Young Mania Rating Scale (YMRS)
Time frame: Week 4 and 8 of treatment duration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a digital product based on CBT in people with Depression and Bipolar Affective Disorder, run by Peking University 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Dec 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weihua Yue (86-010-82805307, dryue@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Hamilton Depression Rating Scale (HAMD) (time frame: Week 4 and 8 of treatment duration). 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 15 Dec 2025.