NCT07064551

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
13mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Aug 2025Jun 2027

First Submitted

Initial submission to the registry

July 11, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

July 11, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

Depressive symptomsMental healthMedical-social collaborationIntegrated health and social careStepped-care intervention

Outcome Measures

Primary Outcomes (1)

  • Changes in Depressive Symptoms

    Patient Health Questionnaire-9 (PHQ-9); range 0-27; higher scores indicate higher levels of depressive symptoms (worse outcome)

    Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

Secondary Outcomes (4)

  • Changes in Anxiety Symptoms

    Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  • Changes in Loneliness

    Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  • Changes in Health Service Use

    Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  • Changes in Health-Related Quality of Life

    Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

Other Outcomes (6)

  • Self-Criticism and Self-Reassurance

    Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  • Rumination

    Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  • Resilience

    Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  • +3 more other outcomes

Study Arms (2)

JC JoyAge stepped-care model

EXPERIMENTAL
Behavioral: Cognitive behavioural therapy-based stepped-care interventionOther: Self-management booklet

Usual care with minimal support

OTHER
Other: Self-management booklet

Interventions

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.

JC JoyAge stepped-care model

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.

JC JoyAge stepped-care modelUsual care with minimal support

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • A known history of autism spectrum disorder, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia
  • Communication difficulties that preclude participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

DepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Terry YS Lum, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR
  • Gloria HY Wong, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR
  • Wai Chi Chan, MBChB

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Du, PhD

CONTACT

Walker SH Au

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking was no possible in this study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 11, 2025

First Posted

July 14, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to participant confidentiality reasons.

Locations