Machine Learning-based Classification of Symptom Clusters and Online CBT

NCT06350201 | Recruiting

• 1 other identifier: KY2024.0124.02
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

machine learning approach; CBT; PST; depression; anxiety

Outcome Measures

Primary Outcomes (2)

• The Patient Health Questionnaire (PHQ-9)

  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

  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

  Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32

• WHODAS 2.0

  Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32

• EQ-5D-5L

  Baseline, week 1, week 4, week 6, week 8, week 12, week 20, week 32

Other Outcomes (2)

• remission rate

  week 8, week 12, week 20, week 32

• SBQ-R

  week -1 pre-screening

Study Arms (2)

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.

Behavioral: problem solving therapy

treatment as usual

PLACEBO COMPARATOR

Care as usual with the PST-PC learning manual and generic information from the same domains (BBTI, mindfulness, and physical activity) included in the intervention group's daily check-ins

Other: control group

Interventions

problem solving therapy BEHAVIORAL

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

8 weeks Problem-solving therapy

control group OTHER

Routine psychological care and guidance on mood management

treatment as usual

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 64 years. PHQ-9 ≥10 and/or GAD-7 ≥8 at baseline assessment defined as the threshold for caseness.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan Mental Health Centre: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)