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NCT Number: NCT07064551

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Personal Satisfaction Psychological Well-Being

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioural therapy-based stepped-care intervention

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

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Changes in Anxiety Symptoms

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

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

  2. Changes in Loneliness

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

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

  3. Changes in Health Service Use

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

    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.

  4. Changes in Health-Related Quality of Life

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

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

Other outcomes

  1. Self-Criticism and Self-Reassurance

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

    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)

  2. Rumination

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

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

  3. Resilience

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

    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)

  4. General Self-Efficacy

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

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

  5. Stressful Events

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

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

  6. Perceived Neighbourhood Environment

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Walker SH Au

CONTACT

[email protected]

Yao Du, PhD

CONTACT

[email protected]

852-39175594

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Castle Peak Hospital
  • Hospital Authority Hong Kong West Cluster
  • Kowloon Hospital, Hong Kong
  • Kwai Chung Hospital
  • Pamela Youde Nethersole Eastern Hospital
  • United Christian Hospital

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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