- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06350201
Machine Learning-based Classification of Symptom Clusters and Online CBT
August 31, 2026 updated by: Wuhan Mental Health Centre
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
409
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Wuhan, China
- Renmin Hospital of Wuhan University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged between 18 and 64 years. PHQ-9 ≥10 and/or GAD-7 ≥8 at baseline assessment defined as the threshold for caseness.
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 8 weeks Problem-solving therapy
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. |
Problem-solving therapy-based holistic emotion management interventions matched to individual symptoms
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Placebo Comparator: treatment as usual
Care as usual with the PST-PC learning manual and health education information.
|
Routine psychological care and guidance on mood management
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 12, week 20, week 32
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|
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
|
Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 12, week 20, week 32
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PSQI
Time Frame: Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32
|
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
|
Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32
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EQ-5D-5L
Time Frame: Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32
|
Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SBQ-R
Time Frame: week -1 pre-screening
|
It was utilized to assess suicide ideation for exclusion
|
week -1 pre-screening
|
|
remission rate
Time Frame: week 8
|
PHQ-9 < 5 AND/OR GAD-7 < 5
|
week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Actual)
April 17, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
April 1, 2024
First Submitted That Met QC Criteria
April 1, 2024
First Posted (Actual)
April 5, 2024
Study Record Updates
Last Update Posted (Actual)
September 1, 2026
Last Update Submitted That Met QC Criteria
August 31, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY2024.0124.02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.