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
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:
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 →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.
Exclusion Criteria:
Behavioral: Cognitive behavioural therapy-based stepped-care intervention
Other: Self-management booklet
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.
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.
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
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
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
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
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
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
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
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
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
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
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
Plan to share: No — IPD will not be shared due to participant confidentiality reasons.
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