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

NCT06658041 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2025-07-25

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

OTHER

Care-as-usual

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

Sponsors & Collaborators

  • The Hong Kong Jockey Club Charities Trust

    collaborator OTHER
  • Baptist Oi Kwan Social Service

    collaborator OTHER
  • Caritas Hong Kong, Hong Kong

    collaborator UNKNOWN
  • Christian Family Service Centre

    collaborator OTHER
  • Fu Hong Society

    collaborator UNKNOWN
  • Haven of Hope Hospital

    collaborator OTHER
  • Hong Kong Christian Service

    collaborator OTHER
  • Hong Kong Sheng Kung Hui Welfare Council Limited

    collaborator OTHER
  • Hong Kong Young Women's Christian Association

    collaborator OTHER
  • The Mental Health Association of Hong Kong

    collaborator OTHER
  • Neighbourhood Advice-Action Council

    collaborator OTHER
  • New Life Psychiatric Rehabilitation Association

    collaborator OTHER
  • Richmond Fellowship of Hong Kong

    collaborator UNKNOWN
  • Hong Kong Sheng Kung Hui Lady MacLehose Centre

    collaborator UNKNOWN
  • SideBySide

    collaborator UNKNOWN
  • St. James' Settlement

    collaborator OTHER
  • The Hong Kong Society for the Aged

    collaborator UNKNOWN
  • The Salvation Army, Hong Kong and Macau Command

    collaborator OTHER
  • Tung Wah Group of Hospitals

    collaborator OTHER
  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Terry YS Lum, Ph.D. · The University of Hong Kong

  • Gloria HY Wong, Ph.D. · University of Reading; The University of Hong Kong

  • Wai Chi Chan, MBChB · The University of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-23
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06658041 on ClinicalTrials.gov