NCT06528132

Brief Summary

Preliminary findings from a previous study conducted by the investigators suggest that a task-shared approach with modified mindfulness-based cognitive therapy (MBCT) supported by social workers is beneficial in managing depressive symptoms and improving mindful non-reactivity among older adults. However, the possibility for social workers to lead a mindfulness-based intervention (MBI) independently to improve its scalability and service accessibility remains unclear. The project aims to:

  1. 1.Evaluate the effectiveness of social worker-led MBI in improving depression in older adults with mild to moderate depressive symptoms as compared to care as usual;
  2. 2.Examine the effectiveness of incorporating peer supporters in social worker-led MBI compared to those without peer supporters;
  3. 3.To identify potential mechanisms of change in MBI for depressive symptoms.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2026

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

1.6 years

First QC Date

July 25, 2024

Last Update Submit

November 17, 2024

Conditions

Keywords

Modified mindfulness-based intervention

Outcome Measures

Primary Outcomes (2)

  • Change from baseline depression at Week 6 and Week 18

    Depression will be measured by the validated Chinese version of the Patient Health Questionnaire (PHQ-9). The total score will be used, ranging from 0 to 27. Higher scores indicate higher levels of depressive symptoms.

    Baseline and Week 6, Week 18

  • Change from baseline anxiety at Week 6 and Week 18

    Anxiety will be measured by the validated Chinese version of the Generalized Anxiety Disorder scale (GAD-7). The total score will be used, ranging from 0 to 21. Higher scores indicate higher levels of anxiety symptoms.

    Baseline and Week 6, Week 18

Other Outcomes (8)

  • Change from baseline mindfulness at Week 6 and Week 18

    Baseline and Week 6, Week 18

  • Change from baseline stress at Week 8 and Week 18

    Baseline and Week 6, Week 18

  • Change from baseline quality of life at Week 6 and Week 18

    Baseline and Week 6, Week 18

  • +5 more other outcomes

Study Arms (3)

social worker-led MBI (enhanced with peer supporters)

EXPERIMENTAL

Participants in the social worker-led modified MBI group will receive mindfulness training from social workers. In addition, they will receive support from peer supporters.

Behavioral: Mindfulness-based intervention (MBI) (enhanced with peer supporters)

social worker-led MBI (without peer supporters)

EXPERIMENTAL

Participants in the social-worker led modified MBI group will receive mindfulness training from social workers.

Behavioral: Experimental: social worker-led MBI (without peer supporters)

Care as usual group

NO INTERVENTION

The care as usual group will receive usual service provided in District Elderly Community Centres (DECC) and Integrated Community Centre for Mental Wellness (ICCMW).

Interventions

Mindfulness-based intervention combines mindfulness meditation with cognitive behavioural therapy (CBT) elements to reduce or prevent recurrent major depressive disorders. On-site support and regular follow-up by peer supporters.

social worker-led MBI (enhanced with peer supporters)

Mindfulness-based intervention combines mindfulness meditation with cognitive behavioural therapy (CBT) elements to reduce or prevent recurrent major depressive disorders.

social worker-led MBI (without peer supporters)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • have depressive symptoms of mild level or above, as indicated by scoring 5-14 on PHQ-9
  • can give informed consent to participate

You may not qualify if:

  • known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia
  • current abuse of drugs or alcohol
  • difficulty in communication
  • imminent suicidal risk
  • timing or training is unsuitable for the participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Hong Kong Society for the Aged

Eastern District, Hong Kong

RECRUITING

HKSKH Lok Man Alice Kwok Integrated Service Centre

Kowloon City, Hong Kong

RECRUITING

SKH Holy Carpenter Church

Kowloon City, Hong Kong

RECRUITING

The Mental Health Association of Hong Kong

Kwun Tong, Hong Kong

RECRUITING

Haven of Hope District Elderly Community Service

Sai Kung, Hong Kong

NOT YET RECRUITING

Wellness Zone - Integrated Community Centre for Mental Wellness

Sai Kung, Hong Kong

NOT YET RECRUITING

HKSKH Western District Elderly Community Centre

Sai Wan, Hong Kong

NOT YET RECRUITING

TWGHs Lok Hong Integrated Community Centre for Mental Wellness

Sai Wan, Hong Kong

RECRUITING

Wilson T.S. Wang District Elderly Community Centre

Shatin, Hong Kong

RECRUITING

Aberdeen Kai-fong Welfare Association

Southern District, Hong Kong

NOT YET RECRUITING

The Salvation Army Taipo Multi-Service Centre for Senior Citizens

Tai Po, Hong Kong

RECRUITING

The Neighbourhood Advice-Action Council

Tuenmen, Hong Kong

RECRUITING

SKH Wong Tai Sin District Elderly Community Centre

Wong Tai Sin, Hong Kong

NOT YET RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Terry YS Lum, PhD

    Department of Social Work and Social Administration, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dara KY Leung, PhD

CONTACT

Zuna LY Ng

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants in the intervention group will receive mindfulness-based intervention from social workers either with or without peer supporters involved. The care as usual group will receive usual service provided in District Elderly Community Centres (DECC) and Integrated Community Centre for Mental Wellness (ICCMW).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2024

First Posted

July 30, 2024

Study Start

July 23, 2024

Primary Completion

March 16, 2026

Study Completion

March 16, 2026

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations