Collaborative Stepped-care Intervention for Adults With Subthreshold Depressive Symptoms in the Primary Care Setting
NCT ID: NCT06658041
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
352 participants
INTERVENTIONAL
2024-12-23
2027-06-30
Brief Summary
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Detailed Description
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Since 2016, the research team has developed a collaborative stepped-care model for older people at-risk of or with depression in Hong Kong through the Jockey Club Holistic Support Project for Elderly Mental Wellness (JC JoyAge) (Clinical Trials Identifier: NCT03593889); the effectiveness and cost-effectiveness of which has been demonstrated, thereby leading to its implementation in social care settings across all 18 districts of Hong Kong.
To further improve the accessibility and availability of mental health services in the community and to reduce the burden associated with depression and related conditions, the JoyAge collaborative stepped-care intervention (cognitive behavioural therapy-based) will be expanded to target adults aged 45 years and above at the district-based primary care setting. This study thus sought to evaluate the effectiveness of this expanded intervention model.
Objective: To examine the effectiveness of the collaborative stepped-care intervention for adults with subthreshold depressive symptoms, as compared with propensity score-matched controls, in reducing depressive symptoms (primary outcome) both post-intervention (T1) and for up to 3 months of follow-up (T2). Secondary outcomes of the study include reduced anxiety symptoms, reduced loneliness, reduced rumination, improved social support, improved health-related quality of life, as well as improved quality-adjusted life years, and reduced healthcare service utilisation.
Design: While a randomised controlled trial would be ideal, such a study design was not possible in our current study context given pragmatic reasons. A quasi-experimental randomised controlled trial involving an (i) intervention arm and (ii) control arm will therefore be adopted. A targeted sample of 352 participants will be recruited (n = 176 per arm). To more rigorously account for potential differences in the sample characteristics of the two arms, propensity-score matching will be applied. After the pre-intervention or baseline (T0), assessments will be conducted at two follow-up time points: post-intervention (9-month post-baseline in the active control group, which is aligned with the median service duration in the intervention arm; T1), and 3-month post-intervention (12-month post-baseline in the active control group; T2).
Study setting
In Hong Kong, there is now at least one core district-based primary care centre at each of the 18 districts locally. Aside from the regular JoyAge intervention offered in the social care setting, the present study will focus on the effectiveness of the JoyAge intervention carried out at three main primary care centre sites in Hong Kong. Participants of the control group will be recruited from the community, comprising individuals who may be receiving services from non-JoyAge-partnered district-based primary care centres (that are not actively offering psychological interventions) or other services.
Power calculation for sample size
Taking a more conservative effect size reported in a meta-analysis examining the effects of psychotherapy for subclinical depression (using the lower confidence interval \[CI\] of CBT, yielding f = 0.14) (Cuijpers et al., 2014), a minimum sample size of 270 is required to achieve a power of 80% at the 0.05 alpha level. Further accounting for a potential 30% attrition given the setting in which this study is conducted, a total sample of 352 is targeted (n = 176 per arm).
Procedures and intervention: Experimental group
For those in the JoyAge partnered district-based primary care centres, participants identified to be showing some symptoms of depression (Patient Health Questionnaire-2-item ≥ 3) will be directed to the JoyAge team for a more in-depth assessment, involving the completion of a full Patient Health Questionnaire-9-item (PHQ-9). Those meeting the study inclusion criteria (see below) and have provided informed consent will be provided with interventions according to initial symptom severity, which are predominantly based on cognitive behavioural therapy (CBT) with a stepped-care element. Details are as follows:
* For those with mild symptoms (PHQ-9 = 5-9) without major risks: 4 weekly CBT-informed intervention sessions led by trained Emotional Support Assistants (ESA) (Peer Supporters with 80hrs mental health training + 15hrs intensive clinical training).
* For those with mild symptoms (PHQ-9 = 5-9) with major risk factors or moderate-to-moderately severe symptoms (PHQ-9 = 10-19): 6 weekly CBT-based intervention sessions led by trained clinical social workers, with 2 booster sessions as necessary. Individual CBT-based intervention will be provided to those unsuitable for group interventions.
Based on the initial trial of intervention, participants may be either "stepped-up" or "stepped-down" (or exit from service). Specifically:
\- For all participants who were unable to achieve clinical remission following the first trial of intervention (PHQ-9 ≥ 5): a second trial of intervention will be provided with greater intensity (e.g., those receiving ESA-led interventions may be stepped up to worker-led interventions). Those needing additional support will be referred to a partnered General Practitioner (if PHQ-9=10-19) or referred to more intensive psychological or psychiatric services as needed.
\*Definition of major risk factors: PHQ-9 item 9 (suicidal ideation) ≥ 2; moderate symptoms of generalised anxiety disorder (GAD-7 ≥ 10); high loneliness (UCLA 3-item ≥ 7); recent highly stressful or traumatic event (e.g., bereavement, domestic violence); complex high-risk condition (e.g., major family issues).
The recommended service period will be 6-9 months. All assessments will be conducted pre-intervention/baseline (T0), post-intervention (i.e., exit from service; T1), and 3-month post-intervention (T2).
Procedures and intervention: Active control group
Participants will be from community members who are not receiving services from the JoyAge-partnered district-based primary care centres. Upon identification of potential presentation of depressive symptoms, a trained research assistant will further verify their eligibility. Upon confirmation of their eligibility and informed consent provision, assessments will be conducted by a trained research assistant at baseline (T0), at 9-month follow-up (T1) \[\*aligned with the median service duration in the experimental group\], and 12-month follow-up (T2). To ensure the baseline characteristics of the two groups are similar, propensity score matching will be applied, accounting for core demographics (e.g., sex, age) and initial symptom severity (e.g., mild / moderate / moderately severe).
Statistical methods
Sample characteristics will be examined and reported for both experimental arms at all time points. The primary analysis will follow an intention-to-treat (ITT) principle (i.e., all participants will be included as long as they were randomised, and based on their randomised allocation, regardless of the intervention they received or rate of completion).
To test the effects of the intervention on the primary and secondary outcomes of the present study, two approaches will be adopted:
1. Between-group differences will first be analysed using the generalised linear models. Core sociodemographics would be adjusted in these models. Unstandardised coefficients and effect sizes (Cohen's d) with 95% confidence intervals will be reported.
2. Linear mixed models will be applied to further confirm the results, which would account for the random effects at individual participant level.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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JoyAge stepped-care intervention
Participants are provided with specified interventions (cognitive behavioural therapy-based) according to their depressive symptom severity at the primary care setting provided by trained clinical social workers, and may be stepped-up or stepped-down according to their response.
Cognitive behavioural therapy (CBT)-based intervention with stepped-care
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) without major risks (\*see above): 4 weekly CBT-informed intervention sessions led by trained Emotional Support Assistants (Peer Supporters with 80hrs mental health training + 15hrs intensive clinical training).
Mild symptoms (PHQ-9=5-9) with major risk factors or moderate-to-moderately severe symptoms (PHQ-9=10-19): 6 weekly CBT-based intervention sessions led by trained clinical social workers, with 2 booster sessions as necessary. Individual CBT-based intervention will be provided to those unsuitable for group interventions.
In cases of non-remission (PHQ-9≥5): a second intervention trial will be provided. Those needing additional support will be referred to a partnered General Practitioner (if PHQ-9=10-19) or referred to more intensive psychological or psychiatric services as needed.
Care-as-usual
Participants will continue with any services they are receiving (non-JoyAge intervention), which may entail services such as stress management or health-related programmes but without symptom-specific psychological interventions or stepped-care.
Care-as-usual
Following an initial interview session with research assessments, participants continue with their usual care at their primary care setting.
Interventions
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Cognitive behavioural therapy (CBT)-based intervention with stepped-care
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) without major risks (\*see above): 4 weekly CBT-informed intervention sessions led by trained Emotional Support Assistants (Peer Supporters with 80hrs mental health training + 15hrs intensive clinical training).
Mild symptoms (PHQ-9=5-9) with major risk factors or moderate-to-moderately severe symptoms (PHQ-9=10-19): 6 weekly CBT-based intervention sessions led by trained clinical social workers, with 2 booster sessions as necessary. Individual CBT-based intervention will be provided to those unsuitable for group interventions.
In cases of non-remission (PHQ-9≥5): a second intervention trial will be provided. Those needing additional support will be referred to a partnered General Practitioner (if PHQ-9=10-19) or referred to more intensive psychological or psychiatric services as needed.
Care-as-usual
Following an initial interview session with research assessments, participants continue with their usual care at their primary care setting.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presenting mild to moderately severe depressive symptoms (PHQ-9 = 5-19);
* Able to give informed consent to participate.
Exclusion Criteria
* Imminent suicidal risk;
* Difficulty in communication that would limit meaningful participation in psychological intervention.
45 Years
59 Years
ALL
No
Sponsors
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The Hong Kong Jockey Club Charities Trust
OTHER
Baptist Oi Kwan Social Service
OTHER
Caritas Hong Kong, Hong Kong
UNKNOWN
Christian Family Service Centre
OTHER
Fu Hong Society
UNKNOWN
Haven of Hope Hospital
OTHER
Hong Kong Christian Service
OTHER
Hong Kong Sheng Kung Hui Welfare Council Limited
OTHER
Hong Kong Young Women's Christian Association
OTHER
The Mental Health Association of Hong Kong
OTHER
Neighbourhood Advice-Action Council
OTHER
New Life Psychiatric Rehabilitation Association
OTHER
Richmond Fellowship of Hong Kong
UNKNOWN
Hong Kong Sheng Kung Hui Lady MacLehose Centre
UNKNOWN
SideBySide
UNKNOWN
St. James' Settlement
OTHER
The Hong Kong Society for the Aged
UNKNOWN
The Salvation Army, Hong Kong and Macau Command
OTHER
Tung Wah Group of Hospitals
OTHER
The University of Hong Kong
OTHER
Responsible Party
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Professor Terry Y.S. Lum
Professor
Principal Investigators
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Terry YS Lum, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Gloria HY Wong, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Reading; The University of Hong Kong
Wai Chi Chan, MBChB
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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The University of Hong Kong
Hong Kong, HONG KONG, Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Dara KY Leung, Ph.D.
Role: backup
Other Identifiers
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UW 20-246
Identifier Type: -
Identifier Source: org_study_id
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