Clinical trial NCT06528132: Social Worker-led Mindfulness-based Intervention for Older People
Official title: Social Worker-led Mindfulness-based Intervention for Managing Depressive Symptoms in Community-dwelling Older Adults in Hong Kong: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Keywords: Modified mindfulness-based intervention
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
name: Christian Family Service Centre
name: The Mental Health Association of Hong Kong
name: The Salvation Army, Hong Kong and Macau Command
name: Haven of Hope Hospital
name: Hong Kong Sheng Kung Hui
name: Tung Wah Group of Hospitals
name: Aberdeen Kai-fong Welfare Association
name: Hong Kong Society for the Aged
name: Neighbourhood Advice-Action Council
First posted: 2024-07-30
Enrollment: 207
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline depression at Week 6 and Week 18
timeFrame: Baseline and Week 6, Week 18
measure: Change from baseline anxiety at Week 6 and Week 18
timeFrame: Baseline and Week 6, Week 18
Secondary outcomes:
Other outcomes:
measure: Change from baseline mindfulness at Week 6 and Week 18
timeFrame: Baseline and Week 6, Week 18
measure: Change from baseline stress at Week 8 and Week 18
timeFrame: Baseline and Week 6, Week 18
measure: Change from baseline quality of life at Week 6 and Week 18
timeFrame: Baseline and Week 6, Week 18
measure: Change from baseline self-compassion at Week 6 and Week 18
timeFrame: Baseline and Week 6, Week 18
measure: Change from baseline rumination at Week 6 and Week 18
timeFrame: Baseline and Week 6, Week 18
measure: Change from baseline self-efficacy at Week 6 and Week 18
timeFrame: Baseline and Week 6, Week 18
measure: Change from baseline resilience at Week 6 and Week 18
timeFrame: Baseline and Week 6, Week 18
measure: Change from baseline general health status at Week 6 and Week 18
timeFrame: Baseline and Week 6, Week 18
Locations:
city: Eastern District
country: Hong Kong
facility: Hong Kong Society for the Aged
city: Kowloon City
country: Hong Kong
facility: HKSKH Lok Man Alice Kwok Integrated Service Centre
city: Kowloon City
country: Hong Kong
facility: SKH Holy Carpenter Church
city: Kwun Tong
country: Hong Kong
facility: The Mental Health Association of Hong Kong
city: Sai Kung
country: Hong Kong
facility: Haven of Hope District Elderly Community Service
city: Sai Kung
country: Hong Kong
facility: Wellness Zone - Integrated Community Centre for Mental Wellness
city: Sai Wan
country: Hong Kong
facility: HKSKH Western District Elderly Community Centre
city: Sai Wan
country: Hong Kong
facility: TWGHs Lok Hong Integrated Community Centre for Mental Wellness
city: Sha Tin
country: Hong Kong
facility: Wilson T.S. Ｗang District Elderly Community Centre
city: Southern District
country: Hong Kong
facility: Aberdeen Kai-fong Welfare Association
city: Tai Po
country: Hong Kong
facility: The Salvation Army Taipo Multi-Service Centre for Senior Citizens
city: Tuen Mun
country: Hong Kong
facility: The Neighbourhood Advice-Action Council
city: Wong Tai Sin
country: Hong Kong
facility: SKH Wong Tai Sin District Elderly Community Centre
Study officials:
affiliation: Department of Social Work and Social Administration, The University of Hong Kong
name: Terry YS Lum, PhD
role: PRINCIPAL_INVESTIGATOR
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