DepressionNCT07064551
Evaluation Study of Medical-Social Collaboration Model for Middle-aged and Older Adults With Depressive Symptoms
A study testing Cognitive behavioural therapy-based stepped-care intervention and Self-management booklet in people with Depression, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive behavioural therapy-based stepped-care intervention and Self-management booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Jun 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently awaiting psychiatric services provided by the Hospital Authority
- Have depressive symptoms of at least mild severity
- Able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Walker SH Au contact
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Yao Du, PhD, 852-39175594, yaodu@hku.hk
Walker SH Au, ashwalk@hku.hk
About this study
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.
Read more
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
- Being tested
- Cognitive behavioural therapy-based stepped-care intervention, Self-management booklet
- Keywords
- Depressive symptoms, Mental health, Medical-social collaboration, Integrated health and social care, Stepped-care intervention
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapy-based stepped-care interventionBehavioural
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 bookletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| JC JoyAge stepped-care model | Experimental | Not described Receives: Behavioral: Cognitive behavioural therapy-based stepped-care intervention |
| Usual care with minimal support | Other | Not described Receives: Other: Self-management booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9); range 0-27; higher scores indicate higher levels of depressive symptoms (worse outcome)
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months
Secondary outcomes (4)
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)
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months
Changes in Loneliness
UCLA Loneliness Scale (UCLA-3); range 0-9; higher scores indicate higher levels of perceived loneliness (worse outcome)
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months
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)
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start20 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Professor Terry Y.S. Lum, The University of Hong Kong
- Investigators
- Terry YS Lum, PhD, Principal investigator, The University of Hong KongGloria HY Wong, PhD, Principal investigator, University of ReadingWai Chi Chan, MBChB, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064551
- Sponsor's protocol ID
- UW 24-649
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to participant confidentiality reasons.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Study of Medical-Social Collaboration Model for Middle-aged and Older Adults With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT07064551
- Acronym / sponsor ID
- UW 24-649
- Conditions
- Depression
- Keywords
- Depressive symptoms, Mental health, Medical-social collaboration, Integrated health and social care, Stepped-care intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- 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
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JC JoyAge stepped-care model | Experimental | Behavioral: Cognitive behavioural therapy-based stepped-care intervention |
| Usual care with minimal support | Other | Other: Self-management booklet |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently awaiting psychiatric services provided by the Hospital Authority
- Have depressive symptoms of at least mild severity
- Able to provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural therapy-based stepped-care interventionAfter 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. | Behavioural | JC JoyAge stepped-care model |
| Self-management bookletThe 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. | Other | Usual care with minimal support |
Primary outcome
Changes in Depressive Symptoms
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months
Patient Health Questionnaire-9 (PHQ-9); range 0-27; higher scores indicate higher levels of depressive symptoms (worse outcome)
4 secondary outcomes
Changes in Anxiety Symptoms
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months
Changes in Loneliness
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months
Changes in Health Service Use
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months
Changes in Health-Related Quality of Life
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to participant confidentiality reasons.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Walker SH Au contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy-based stepped-care intervention and Self-management booklet in people with Depression, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao Du, PhD (852-39175594, yaodu@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Depressive Symptoms (time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.