Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06528132

Social Worker-led Mindfulness-based Intervention for Older People

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Society for the Aged, Eastern District, Hong Kong

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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)

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dara KY Leung, PhD

CONTACT

[email protected]

3917-0081

Zuna LY Ng

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Aberdeen Kai-fong Welfare Association
  • Christian Family Service Centre
  • Haven of Hope Hospital
  • Hong Kong Sheng Kung Hui
  • Hong Kong Society for the Aged
  • Neighbourhood Advice-Action Council
  • The Hong Kong Jockey Club Charities Trust
  • The Mental Health Association of Hong Kong
  • The Salvation Army, Hong Kong and Macau Command
  • Tung Wah Group of Hospitals

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.