Depression and Anxiety SymptomNCT06350201
Machine Learning-based Classification of Symptom Clusters and Online CBT
A study testing problem solving therapy in people with Depression and Anxiety Symptom, run by Wuhan Mental Health Centre at 1 site in China.
Trial summary
To breakthrough the bottleneck identified, we will conduct a cross-sectional study to develop a symptom clustering model for depression and anxiety. A wide range of statistical methods as well as machine learning approaches were explored, and a cohesive hierarchical clustering algorithm will be used. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression and Anxiety Symptom
- What is being tested?
- problem solving therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 64 years. PHQ-9 ≥10 and/or GAD-7 ≥8 at baseline assessment defined as the threshold for caseness.
Who cannot join
- People will be excluded if they meet any of the following criteria:
- They are receiving psychological therapy during an interview for any mental health issue;
- currently acutely suicidal or have attempted suicide in the past 2 months, as indicated by PHQ-9 item 9;
- cognitively impaired or diagnosed with bipolar disorder or psychosis or experiencing psychotic symptoms; d) dependent on alcohol or drugs; e) living with an unstable or acute medical illness that would interfere with trial participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Machine Learning-based Classification of Symptom Clusters and Matched Online Cognitive Behavior Intervention for Depression Symptom and Anxiety Symptom
To breakthrough the bottleneck identified, we will conduct a cross-sectional study to develop a symptom clustering model for depression and anxiety. A wide range of statistical methods as well as machine learning approaches were explored, and a cohesive hierarchical clustering algorithm will be used. After developing the model, a symptom-matched intervention program based on problem solving therapy will be formulated. We are supposed to examine whether its use for personalizing symptom-matched psychological treatment can lead to improved patient outcomes, compared with usual care. This project is expected to provide a new and precise method for the emotion management, which will provide a standardized intervention pathway combining screening with treatment for the management of depression symptom and anxiety symptom. A preciser intervention matched to individual symptoms may provide important insight in improving patient outcome as well as a standardized mood management pathway targeting to the early detection and intervention for community residents.
- Conditions
- Depression and Anxiety Symptom
- Being tested
- problem solving therapy, control group
- Keywords
- machine learning approach, CBT, PST, depression, anxiety
- 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.
problem solving therapyBehavioural
Problem-solving therapy-based holistic emotion management interventions matched to individual symptoms
control groupOther
Routine psychological care and guidance on mood management
| Study group | Role | What they receive |
|---|---|---|
| 8 weeks Problem-solving therapy | Experimental | Problem-solving therapy imparts problem-solving abilities applicable to participants' daily lives.
Personalized therapies, including brief behavioral treatment of insomnia, mindfulness, and physical exercise suggestions, were tailored to correspond with patients' specific clusters of sadness and anxiety symptoms. Receives: Behavioral: problem solving therapy |
| treatment as usual | Active comparator | Care as usual with the PST-PC learning manual and self-learning health education information. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Patient Health Questionnaire (PHQ-9)
Measured: Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 12, week 20, week 32
GAD-7
Measured: Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 12, week 20, week 32
Secondary outcomes (3)
PSQI
Measured: Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32
WHODAS 2.0
Measured: Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32
EQ-5D-5L
Measured: Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32
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 start1 Sep 2025
- Primary completion30 Jul 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression and Anxiety SymptomStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Mental Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Renmin Hospital of Wuhan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350201
- Sponsor's protocol ID
- KY2024.0124.02
- Status last verified
- May 2026
- First submitted
- 1 Apr 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning-based Classification of Symptom Clusters and Matched Online Cognitive Behavior Intervention for Depression Symptom and Anxiety Symptom
- ClinicalTrials.gov ID
- NCT06350201
- Acronym / sponsor ID
- KY2024.0124.02
- Conditions
- Depression and Anxiety Symptom
- Keywords
- machine learning approach, CBT, PST, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Wuhan Mental Health CentreUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Renmin Hospital of Wuhan University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 1 Dec 2026 (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.
To breakthrough the bottleneck identified, we will conduct a cross-sectional study to develop a symptom clustering model for depression and anxiety. A wide range of statistical methods as well as machine learning approaches were explored, and a cohesive hierarchical clustering algorithm will be used. After developing the model, a symptom-matched intervention program based on problem solving therapy will be formulated. We are supposed to examine whether its use for personalizing symptom-matched psychological treatment can lead to improved patient outcomes, compared with usual care. This project is expected to provide a new and precise method for the emotion management, which will provide a standardized intervention pathway combining screening with treatment for the management of depression symptom and anxiety symptom. A preciser intervention matched to individual symptoms may provide important insight in improving patient outcome as well as a standardized mood management pathway targeting to the early detection and intervention for community residents.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 weeks Problem-solving therapy | Experimental | Behavioral: problem solving therapyProblem-solving therapy imparts problem-solving abilities applicable to participants' daily lives. Personalized therapies, including brief behavioral treatment of insomnia, mindfulness, and physical exercise suggestions, were tailored to correspond with patients' specific clusters of sadness and anxiety symptoms. |
| treatment as usual | Active comparator | Other: control groupCare as usual with the PST-PC learning manual and self-learning health education information. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged between 18 and 64 years. PHQ-9 ≥10 and/or GAD-7 ≥8 at baseline assessment defined as the threshold for caseness.
Key exclusion criteria (4 listed)
- People will be excluded if they meet any of the following criteria:
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 |
|---|---|---|
| problem solving therapyProblem-solving therapy-based holistic emotion management interventions matched to individual symptoms | Behavioural | 8 weeks Problem-solving therapy |
| control groupRoutine psychological care and guidance on mood management | Other | treatment as usual |
Primary outcome
The Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 12, week 20, week 32
GAD-7
Time frame: Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 12, week 20, week 32
3 secondary outcomes
PSQI
Time frame: Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32
WHODAS 2.0
Time frame: Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32
EQ-5D-5L
Time frame: Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32
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 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 problem solving therapy in people with Depression and Anxiety Symptom, run by Wuhan Mental Health Centre 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 1 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 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. 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?
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?
The Patient Health Questionnaire (PHQ-9) (time frame: Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 12, week 20, week 32). 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 8 Sep 2026.