Machine Learning-based Classification of Symptom Clusters and Online CBT

May 7, 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

380

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

  • China
      • Wuhan, China
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:

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:

    1. They are receiving psychological therapy during an interview for any mental health issue;
    2. currently acutely suicidal or have attempted suicide in the past 2 months, as indicated by PHQ-9 item 9;
    3. 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.
Behavioral: problem solving therapy
Problem-solving therapy-based holistic emotion management interventions matched to individual symptoms
Placebo Comparator: treatment as usual
Care as usual with the PST-PC learning manual and health education information.
Other: control group
Routine psychological care and guidance on mood management

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
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
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
remission rate
Time Frame: week 8, week 12, week 20, week 32
PHQ-9 < 5 AND/OR GAD-7 < 5
week 8, week 12, week 20, week 32
SBQ-R
Time Frame: week -1 pre-screening
It was utilized to assess suicide ideation for exclusion
week -1 pre-screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Mental Health Centre

Collaborators

National Natural Science Foundation of China

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 (Estimated)

May 1, 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)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 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)?

NO

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.

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