Social Worker-led Mindfulness-based Intervention for Older People

November 17, 2024 updated by: Professor Terry Y.S. Lum, The University of Hong Kong

Social Worker-led Mindfulness-based Intervention for Managing Depressive Symptoms in Community-dwelling Older Adults in Hong Kong: A Randomised Controlled Trial

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. 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. Examine the effectiveness of incorporating peer supporters in social worker-led MBI compared to those without peer supporters;
  3. To identify potential mechanisms of change in MBI for depressive symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Mindfulness-based cognitive therapy (MBCT) is a promising approach to managing a series of health and psychological conditions among older adults. To increase its acceptability, feasibility, and scalability, MBCT has been adapted and delivered in a variety of formats. Apart from delivering the intervention in person by a certified mindfulness teacher, MBCT has been adapted to be self-taught, delivered online, or partially led by social workers.

In a previous study conducted by the investigators, it was found that a task-shared approach with modified MBCT supported by social workers is effective in producing change in older adults' mental health and mindfulness. However, whether social workers are competent to lead a mindfulness-based intervention (MBI) informed by MBCT on their own and produce effective changes in outcome measures pertaining to mental health remains unclear.

Furthermore, the effects of incorporating peer supporters into mental health interventions are unclear. The uses and implementation of peer support across mental health contexts vary greatly and the effects are mixed. In a pilot study on men with advanced prostate cancer, it has been suggested that the presence of peer support in modified mindfulness-based cognitive therapy group intervention may reinforce intervention effects. Furthermore, in an online intervention for older adults with elevated depressive symptoms, peer support has been found to improve engagement and adherence to the intervention. However, in a systematic review and meta-analysis, it has been found that while incorporating one-to-one peer support in mental health services has a modest positive impact on self-reported psychosocial outcomes such as self-rated recovery and empowerment, there is no evidence for improvement in clinical outcomes.

With the growing older people population and a need for greater social welfare capacity to promote older adults' well-being, the current study aims to examine the effectiveness of social worker-led MBI informed by MBCT in improving depression in older adults with mild to moderate depressive symptoms. In addition, the effectiveness of incorporating peer supporters into the intervention will be examined.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dara KY Leung, PhD
  • Phone Number: 3917-0081
  • Email: daralky@hku.hk

Study Contact Backup

Study Locations

  • Hong Kong
      • Eastern District, Hong Kong
        • Recruiting
        • Hong Kong Society for the Aged
        • Contact:
      • Kowloon City, Hong Kong
        • Recruiting
        • HKSKH Lok Man Alice Kwok Integrated Service Centre
        • Contact:
      • Kowloon City, Hong Kong
        • Recruiting
        • SKH Holy Carpenter Church
        • Contact:
      • Kwun Tong, Hong Kong
        • Recruiting
        • The Mental Health Association of Hong Kong
        • Contact:
      • Sai Kung, Hong Kong
        • Not yet recruiting
        • Haven of Hope District Elderly Community Service
        • Contact:
      • Sai Kung, Hong Kong
        • Not yet recruiting
        • Wellness Zone - Integrated Community Centre for Mental Wellness
        • Contact:
      • Sai Wan, Hong Kong
        • Not yet recruiting
        • HKSKH Western District Elderly Community Centre
        • Contact:
      • Sai Wan, Hong Kong
        • Recruiting
        • TWGHs Lok Hong Integrated Community Centre for Mental Wellness
        • Contact:
      • Sha Tin, Hong Kong
        • Recruiting
        • Wilson T.S. Ｗang District Elderly Community Centre
        • Contact:
      • Southern District, Hong Kong
        • Not yet recruiting
        • Aberdeen Kai-fong Welfare Association
        • Contact:
      • Tai Po, Hong Kong
        • Recruiting
        • The Salvation Army Taipo Multi-Service Centre for Senior Citizens
        • Contact:
      • Tuen Mun, Hong Kong
        • Recruiting
        • The Neighbourhood Advice-Action Council
        • Contact:
      • Wong Tai Sin, Hong Kong
        • Not yet recruiting
        • SKH Wong Tai Sin District Elderly Community Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 60 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Care as usual group
The care as usual group will receive usual service provided in District Elderly Community Centres (DECC) and Integrated Community Centre for Mental Wellness (ICCMW).
Experimental: social worker-led MBI (enhanced with peer supporters)
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)
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.
Experimental: social worker-led MBI (without peer supporters)
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)
Mindfulness-based intervention combines mindfulness meditation with cognitive behavioural therapy (CBT) elements to reduce or prevent recurrent major depressive disorders.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline depression at Week 6 and Week 18
Time Frame: Baseline and Week 6, 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
Time Frame: Baseline and Week 6, 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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline mindfulness at Week 6 and Week 18
Time Frame: Baseline and Week 6, Week 18
Mindfulness will be measured by the Chinese validated Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF). The total score of the FFMQ-SF (ranging from 20 to 100) as well as the sum (ranging from 4 to 20) of the five subscales (i.e., observe, describe, acting with awareness, nonjudging, and nonreactivity) will be used. Higher scores indicate higher mindfulness.
Baseline and Week 6, Week 18
Change from baseline stress at Week 8 and Week 18
Time Frame: Baseline and Week 6, Week 18
Stress will be measured by a single-item subjective level of stress (SLS-1), which is rated on a scale from 0 to 10. A higher score indicates a greater subjective level of stress
Baseline and Week 6, Week 18
Change from baseline quality of life at Week 6 and Week 18
Time Frame: Baseline and Week 6, Week 18
Health-related quality of life will be measured by the European Quality of life 5 Dimensions 5 Level Version (EQ-5D-5L) in traditional Chinese. The measure assesses five dimensions of health (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) at five levels (no problem, slight problems, moderate problems, severe problems, and extreme problems). An index value ranging from 0 to 1 will be used, with a score closer to 1 indicating a better health state. Current self-rated health will be measured using a visual analogue scale ranging from 0 to 100, with higher scores indicating better self-rated health.
Baseline and Week 6, Week 18
Change from baseline self-compassion at Week 6 and Week 18
Time Frame: Baseline and Week 6, Week 18
Self-compassion will be measured by the Chinese version of the Self-Compassion Scale-Short Form (SCS-SF). The total score will be used, ranging from 12 to 60. Higher scores indicate higher self-compassion.
Baseline and Week 6, Week 18
Change from baseline rumination at Week 6 and Week 18
Time Frame: Baseline and Week 6, Week 18
Rumination will be measured by the Brooding Subscale of the Ruminative Response Scale (RRS-10 Chinese version). The total score will be used, ranging from 5 to 20. Higher scores indicate a greater rumination tendency.
Baseline and Week 6, Week 18
Change from baseline self-efficacy at Week 6 and Week 18
Time Frame: Baseline and Week 6, Week 18
Self-efficacy will be measured by the Chinese version of the General Self-Efficacy Scale. The total score will be used, ranging from 10 to 40. Higher scores indicate greater self-efficacy.
Baseline and Week 6, Week 18
Change from baseline resilience at Week 6 and Week 18
Time Frame: Baseline and Week 6, Week 18
Resilience will be measured by the Chinese version of the 2-item Connor-Davidson Resilience Scale (CD-RISC2). The total score will be used, ranging from 0 to 8. Higher scores indicate higher resilience.
Baseline and Week 6, Week 18
Change from baseline general health status at Week 6 and Week 18
Time Frame: Baseline and Week 6, Week 18
General health status will be assessed using one non-comparative and two comparative questions pertaining to health. Health status will be measured on a scale ranging from 0 to 4. Higher scores indicate poorer health status.
Baseline and Week 6, Week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Hong Kong Jockey Club Charities Trust
Tung Wah Group of Hospitals
The Salvation Army, Hong Kong and Macau Command
The Mental Health Association of Hong Kong
Christian Family Service Centre
Haven of Hope Hospital
The Neighbourhood Advice-Action Council
Aberdeen Kai-fong Welfare Association
Hong Kong Sheng Kung Hui
Hong Kong Society for the Aged

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Terry YS Lum, PhD, Department of Social Work and Social Administration, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EA220105A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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