Collaborative Stepped-care Intervention for Adults With Subthreshold Depressive Symptoms in the Primary Care Setting

NCT06658041 | Recruiting

• 1 other identifier: UW 20-246
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

To ensure accessibility and availability of mental health services in the community and to reduce the burden associated with depression and related conditions, the study aim to evaluate the effectiveness of a collaborative stepped-care intervention (cognitive behavioural therapy-based) for adults with subthreshold depressive symptoms at the district-based primary healthcare setting.

Conditions

Depression

Keywords

Depressive symptoms; Mental health; Primary care; Stepped-care intervention

Outcome Measures

Primary Outcomes (1)

• Changes in depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])

  The Patient Health Questionnaire-9-item (PHQ-9) is a well-validated measure of depressive symptoms, with items corresponding to the DSM-IV criteria for major depression and which also map onto those of the DSM-V. Items are rated on a 4-point Likert scale and are summed to generate a total score that ranges from 0 to 27. A higher score reflects more severe symptoms.

  T0 (before intervention/baseline); T1 (Intervention group: immediately after intervention; Active control group: 9 months after T0); T2 (3 months after T1)

Secondary Outcomes (6)

• Changes in anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])

  T0 (before intervention/baseline); T1 (Intervention group: immediately after intervention; Active control group: 9 months after T0); T2 (3 months after T1)

• Changes in loneliness symptoms (UCLA Loneliness 3-item [UCLA-3])

  T0 (before intervention/baseline); T1 (Intervention group: immediately after intervention; Active control group: 9 months after T0); T2 (3 months after T1)

• Changes in depressive rumination (RRS-Brooding)

  T0 (before intervention/baseline); T1 (Intervention group: immediately after intervention; Active control group: 9 months after T0); T2 (3 months after T1)

• Changes in social network (LSNS-6)

  T0 (before intervention/baseline); T1 (Intervention group: immediately after intervention; Active control group: 9 months after T0); T2 (3 months after T1)

• Changes in health-related quality of life (EQ-5D)

  T0 (before intervention/baseline); T1 (Intervention group: immediately after intervention; Active control group: 9 months after T0); T2 (3 months after T1)

Study Arms (2)

JoyAge stepped-care intervention

EXPERIMENTAL

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.

Behavioral: Cognitive behavioural therapy (CBT)-based intervention with stepped-care

Care-as-usual

ACTIVE COMPARATOR

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.

Other: Care-as-usual

Interventions

Cognitive behavioural therapy (CBT)-based intervention with stepped-care 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) 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.

Also known as: Psychological intervention, Stepped-care intervention

JoyAge stepped-care intervention

Care-as-usual OTHER

Following an initial interview session with research assessments, participants continue with their usual care at their primary care setting.

Also known as: CAU

Care-as-usual

Eligibility Criteria

• Age: 45 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Residing in Hong Kong;
• Presenting mild to moderately severe depressive symptoms (PHQ-9 = 5-19);
• Able to give informed consent to participate.

You may not qualify if:

• A known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia;
• Imminent suicidal risk;
• Difficulty in communication that would limit meaningful participation in psychological intervention.

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Hong Kong Jockey Club Charities Trust: collaborator
• Baptist Oi Kwan Social Service: collaborator
• Caritas Medical Centre, Hong Kong: collaborator
• Christian Family Service Centre: collaborator
• Fu Hong Society: collaborator
• Haven of Hope Hospital: collaborator
• Hong Kong Christian Service: collaborator
• Hong Kong Sheng Kung Hui Welfare Council Limited: collaborator
• Hong Kong Young Women's Christian Association: collaborator
• The Mental Health Association of Hong Kong: collaborator
• Neighbourhood Advice-Action Council: collaborator
• New Life Psychiatric Rehabilitation Association: collaborator
• Richmond Fellowship of Hong Kong: collaborator
• Hong Kong Sheng Kung Hui Lady MacLehose Centre: collaborator
• SideBySide: collaborator
• St. James' Settlement: collaborator
• The Hong Kong Society for the Aged: collaborator
• The Salvation Army, Hong Kong and Macau Command: collaborator
• Tung Wah Group of Hospitals: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, HONG KONG, 000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depression; Psychological Well-Being

Interventions

Cognitive Behavioral Therapy; Psychosocial Intervention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Terry YS Lum, Ph.D.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Gloria HY Wong, Ph.D.

  University of Reading; The University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Wai Chi Chan, MBChB

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie MY Wong, Ph.D.

CONTACT

+85290371111; stephanie@myinwong.com

Dara KY Leung, Ph.D.

CONTACT

+85239170081; daralky@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Masking was not possible in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A quasi-experimental randomised controlled trial with propensity score-matching of an (i) intervention arm and (ii) active control arm.

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 26, 2024
• Study Start: December 23, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)