Evaluation Study of Medical-Social Collaboration Model for Middle-aged and Older Adults With Depressive Symptoms

NCT ID: NCT07064551

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2027-06-30

Brief Summary

The goal of this clinical trial is to learn if a medical-social collaboration model works to reduce depressive symptoms in middle-aged and older adults with subsyndromal depressive symptoms who are waiting for their first psychiatric appointment. Secondary outcomes of the study include reduced anxiety symptoms, reduced loneliness, reduced rumination, reduced self-criticism, improved self-reassurance, improved resilience, improved self-efficacy, improved health-related quality of life, as well as improved quality-adjusted life years, and reduced healthcare service utilisation.

Researchers will compare a medical-social collaboration model to a self-management booklet.

Participants will:

• Receive CBT-based stepped-care interventions through the medical-social collaboration model or a self-management booklet.
• Complete a survey about their mental health and service use every three months until their first psychiatric appointment.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JC JoyAge stepped-care model

Group Type: EXPERIMENTAL

Cognitive behavioural therapy-based stepped-care intervention

Intervention Type: BEHAVIORAL

After initial clinical assessment, participants will be offered interventions based on their depressive symptom severity (Patient Health Questionnaire-9-item \[PHQ-9\]). Mild symptoms (PHQ-9=5-9): 6 weekly low intensity CBT-based group intervention sessions led by trained clinical social workers, with 2 booster sessions as necessary. Moderate symptoms (PHQ-9=10-14): 6 weekly high intensity CBT-based group intervention sessions led by trained clinical social workers, with 2 booster sessions as necessary. Moderately severe symptoms (PHQ-9≥15): high intensity individual or group CBT-based intervention. Trained peer supporters will be matched to participants to walk them through the process with regular follow-up.

Self-management booklet

Intervention Type: OTHER

The booklet incorporates components of behavioural activation, which encourages participants to engage in meaningful activities in daily life to change their mood. Trained research assistants will regularly check in with the participants to monitor their depressive symptoms.

Usual care with minimal support

Group Type: OTHER

Self-management booklet

Intervention Type: OTHER

The booklet incorporates components of behavioural activation, which encourages participants to engage in meaningful activities in daily life to change their mood. Trained research assistants will regularly check in with the participants to monitor their depressive symptoms.

Interventions

Cognitive behavioural therapy-based stepped-care intervention

After initial clinical assessment, participants will be offered interventions based on their depressive symptom severity (Patient Health Questionnaire-9-item \[PHQ-9\]). Mild symptoms (PHQ-9=5-9): 6 weekly low intensity CBT-based group intervention sessions led by trained clinical social workers, with 2 booster sessions as necessary. Moderate symptoms (PHQ-9=10-14): 6 weekly high intensity CBT-based group intervention sessions led by trained clinical social workers, with 2 booster sessions as necessary. Moderately severe symptoms (PHQ-9≥15): high intensity individual or group CBT-based intervention. Trained peer supporters will be matched to participants to walk them through the process with regular follow-up.

Intervention Type: BEHAVIORAL

Self-management booklet

The booklet incorporates components of behavioural activation, which encourages participants to engage in meaningful activities in daily life to change their mood. Trained research assistants will regularly check in with the participants to monitor their depressive symptoms.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Currently awaiting psychiatric services provided by the Hospital Authority
• Have depressive symptoms of at least mild severity
• Able to provide informed consent

Exclusion Criteria

• A known history of autism spectrum disorder, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia
• Imminent suicidal risk (temporary exclusion)
• Communication difficulties that preclude participation

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Authority Hong Kong West Cluster

UNKNOWN

Sponsor Role: collaborator

Hospital Authority Hong Kong East Cluster

UNKNOWN

Sponsor Role: collaborator

Hospital Authority Kolwoon Central Cluster

UNKNOWN

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Professor Terry Y.S. Lum

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terry YS Lum, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Gloria HY Wong, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Wai Chi Chan, MBChB

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

The University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Yao Du, PhD

Role: CONTACT

yaodu@hku.hk

852-39175594

Walker SH Au

Role: CONTACT

ashwalk@hku.hk

Facility Contacts

Yao Du, PhD

Role: primary

yaodu@hku.hk

852-39175594

Walker SH Au

Role: backup

ashwalk@hku.hk

Other Identifiers

UW 24-649

Identifier Type: -

Identifier Source: org_study_id