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NCT Number: NCT06350201

Machine Learning-based Classification of Symptom Clusters and Online CBT

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Problem solving therapy

Behavioral

Problem-solving therapy-based holistic emotion management interventions matched to individual symptoms

Control Group

Other

Routine psychological care and guidance on mood management

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. PSQI

    Time frame: Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32

  2. WHODAS 2.0

    Time frame: Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32

  3. EQ-5D-5L

    Time frame: Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32

Other outcomes

  1. remission rate

    Time frame: week 8, week 12, week 20, week 32

    PHQ-9 < 5 AND/OR GAD-7 < 5

  2. SBQ-R

    Time frame: week -1 pre-screening

    It was utilized to assess suicide ideation for exclusion

Sponsors and collaborators

Lead sponsor

Wuhan Mental Health Centre

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

Machine Learning-based Classification of Symptom Clusters and Matched Online Cognitive Behavior Intervention for Depression Symptom and Anxiety Symptom

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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