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RecruitingNCT07064551Updated Jul 21, 2026

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

An interventional study of Cognitive behavioural therapy-based stepped-care intervention and Self-management booklet in Depression, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study 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 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.
02

Conditions studied

  • Depression

Keywords

  • Depressive symptoms
  • Mental health
  • Medical-social collaboration
  • Integrated health and social care
  • Stepped-care intervention
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 192 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
192 participants (estimated)

Study arms

  • Experimental
    JC JoyAge stepped-care model

    Behavioral: Cognitive behavioural therapy-based stepped-care intervention

  • Other
    Usual care with minimal support

    Other: Self-management booklet

Interventions

  • BehavioralCognitive 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.

  • OtherSelf-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.

06

What researchers measure

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)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

Secondary outcomes

  1. Changes in Anxiety Symptoms

    Generalized Anxiety Disorder 2-item scale (GAD-2); range 0-6; higher scores indicate higher levels of anxiety symptoms (worse outcome)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  2. Changes in Loneliness

    UCLA Loneliness Scale (UCLA-3); range 0-9; higher scores indicate higher levels of perceived loneliness (worse outcome)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  3. Changes in Health Service Use

    Self-reported use of mental health services and medication in the past three months. Service data from Hospital Authority, covering information on outpatient visits, hospitalisation days, Accident and Emergency service utilisation, types of medications and operations, and any other major cost items that may be affected by depression with cost implications.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  4. Changes in Health-Related Quality of Life

    EQ-5D-5L; range 0-1; higher scores indicate higher levels of health-related quality of life (better outcome)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

Other outcomes

  1. Self-Criticism and Self-Reassurance

    Short Form of Forms of Self-Criticizing/Attacking and Self-Reassuring Scale (FSCRS-SF); higher scores indicate a greater sense of inadequacy (score 0-20) (worse outcome), self-hate (score 0-16) (worse outcome), and self-reassurance (score 0-20) (better outcome)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  2. Rumination

    Ruminative Response Scale - Brooding Subscale (RRS-Brooding); range 0-15; higher scores indicate higher frequency of depressive rumination (worse outcome)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  3. Resilience

    Connor-Davidson Resilience Scale 2-Item (CD-RISC-2); range 0-8; higher scores indicate higher levels of resilience or better equipped to bounce back after stressful events (better outcome)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  4. General Self-Efficacy

    Single-item General Self-Efficacy Scale (SI-DSES); range 1-5; higher scores indicate higher levels of self-efficacy (better outcome)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  5. Stressful Events

    Self-reported stressful events, e.g. illness, death of close relative/friends.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

  6. Perceived Neighbourhood Environment

    Three items on participants' perceptions on their neighbourhood. First, whether participants think they have convenient access to leisure, shopping, community, and medical services and facilities. Second, whether participants think there are sufficient community events and opportunities to know their neighours. Third, whether participants think the neighbourhood is safe enough to walk around.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months

07

Study locations

1 of 1 sites recruiting
  • The University of Hong Kong
    Hong Kong, Hong Kong
    • Yao Du, PhD · Contact · yaodu@hku.hk · 852-39175594
    • Walker SH Au · Contact · ashwalk@hku.hk
    • Terry YS Lum, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — IPD will not be shared due to participant confidentiality reasons.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07064551
Lead sponsor
The University of Hong Kong
Collaborators
Hospital Authority Hong Kong West Cluster, Kowloon Hospital, Hong Kong, Pamela Youde Nethersole Eastern Hospital, United Christian Hospital, Kwai Chung Hospital, Castle Peak Hospital
Responsible party
Professor Terry Y.S. Lum (Professor, The University of Hong Kong) — Principal investigator
First posted
Jul 14, 2025
Start date
Jun 20, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jul 21, 2026

Study contacts

Yao Du, PhD
Contact
yaodu@hku.hk
852-39175594
Walker SH Au
Contact
ashwalk@hku.hk
Terry YS Lum, PhD
principal investigator · The University of Hong Kong
Gloria HY Wong, PhD
principal investigator · University of Reading
Wai Chi Chan, MBChB
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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