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Depressive SymptomsNCT06528132

Social Worker-led Mindfulness-based Intervention for Older People

A study testing Mindfulness-based intervention (MBI) (enhanced with peer supporters) and Experimental: social worker-led MBI (without peer supporters) in people with Depressive Symptoms, run by The University of Hong Kong at 13 sites in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Depressive Symptoms
What is being tested?
Mindfulness-based intervention (MBI) (enhanced with peer supporters) and Experimental: social worker-led MBI (without peer supporters)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
207 participants
Where
13 sitesHong Kong
Study dates
23 Jul 2024to 16 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dara KY Leung, PhD contact

3917-0081

daralky@hku.hk

Zuna LY Ng contact

zunang@hku.hk

13 sites in 1 country

Hong Kong13 sites, 13 recruiting

  • Hong Kong Society for the Aged

    Eastern District

    Wing Sze Chow, +852-2563-0187, winnie.chow@sage.org.hk

    Recruiting

  • HKSKH Lok Man Alice Kwok Integrated Service Centre

    Kowloon City

    Tsz Ying Lam, +852-3501-6734, jtylam@skhwc.org.hk

    Recruiting

  • SKH Holy Carpenter Church

    Kowloon City

    Fung Yee Hui, +852-3960-4351, fhui@skhwc.org.hk

    Recruiting

  • The Mental Health Association of Hong Kong

    Kwun Tong

    May Lan Kou, +852-2346-3798, maykou@mhahk.org.hk

    Recruiting

  • Haven of Hope District Elderly Community Service

    Sai Kung

    Pui Ling Cheng, +852-2702-1113, plcheng@hohcs.org.hk

    Not yet recruiting

  • Wellness Zone - Integrated Community Centre for Mental Wellness

    Sai Kung

    Chak Ling Lee, +852-2706-7198, cl_lee@cfsc.org.hk

    Not yet recruiting

  • HKSKH Western District Elderly Community Centre

    Sai Wan

    Ho Yan Po, +852-2818-3717, hypo@skhwc.org.hk

    Not yet recruiting

  • TWGHs Lok Hong Integrated Community Centre for Mental Wellness

    Sai Wan

    Ka Yee Cheung, +852-3460-6060, winnie.cheung@tungwah.org.hk

    Recruiting

  • Wilson T.S. Ｗang District Elderly Community Centre

    Shatin

    Choi Ha Kok, +852-2647-2711, shelia.kok@tungwah.org.hk

    Recruiting

  • Aberdeen Kai-fong Welfare Association

    Southern District

    Hoi Man Tam, +852-2553-6333, helentam.hm@aka.org.hk

    Not yet recruiting

  • The Salvation Army Taipo Multi-Service Centre for Senior Citizens

    Tai Po

    Wai man Lau, +852-2653-6811, waiman.lau@hkm.salvationarmy.org

    Recruiting

  • The Neighbourhood Advice-Action Council

    Tuenmen

    Siu Ping Yu, +852-2466-6591, tija.sw1@naac.org.hk

    Recruiting

  • SKH Wong Tai Sin District Elderly Community Centre

    Wong Tai Sin

    Pui Yan Tsang, +852-2352-3082, puiyantsang@skhwc.org.hk

    Not yet recruiting

Other trials in Hong Kong

About this study

Official title: 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.
Read the 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.

Being tested
Mindfulness-based intervention (MBI) (enhanced with peer supporters), Experimental: social worker-led MBI (without peer supporters)
Keywords
Modified mindfulness-based intervention
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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)Behavioural

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

Study groups in NCT06528132
Study groupRoleWhat they receive
social worker-led MBI (enhanced with peer supporters)ExperimentalParticipants in the social worker-led modified MBI group will receive mindfulness training from social workers. In addition, they will receive support from peer supporters.
Receives: Behavioral: Mindfulness-based intervention (MBI) (enhanced with peer supporters)
social worker-led MBI (without peer supporters)ExperimentalParticipants in the social-worker led modified MBI group will receive mindfulness training from social workers.
Receives: Behavioral: Experimental: social worker-led MBI (without peer supporters)
Care as usual groupNo interventionThe care as usual group will receive usual service provided in District Elderly Community Centres (DECC) and Integrated Community Centre for Mental Wellness (ICCMW).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 6, Week 18

  2. 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.

    Measured: Baseline and Week 6, Week 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2024
  2. Study start23 Jul 2024
  3. Primary completion16 Mar 2026 (estimated)
  4. Study completion16 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
None (open label)
Enrolment
207 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06528132
Sponsor's protocol ID
EA220105A
Status last verified
Nov 2024
First submitted
25 Jul 2024
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dragomanovich HM, Dhruva A, Ekman E, Schoenbeck KL, Kubo A, Van Blarigan EL, Borno HT, Esquivel M, Chee B, Campanella M, Philip EJ, Rettger JP, Rosenthal B, Van Loon K, Venook AP, Boscardin C, Moran P, Hecht FM, Atreya CE. Being Present 2.0: Online Mindfulness-Based Program for Metastatic Gastrointestinal Cancer Patients and Caregivers. Glob Adv Health Med. 2021 Nov 3;10:21649561211044693. doi: 10.1177/21649561211044693. eCollection 2021.

    PubMed 35174001

  • Hazlett-Stevens H, Singer J, Chong A. Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy with Older Adults: A Qualitative Review of Randomized Controlled Outcome Research. Clin Gerontol. 2019 Jul-Sep;42(4):347-358. doi: 10.1080/07317115.2018.1518282. Epub 2018 Sep 11.

    PubMed 30204557

  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

    PubMed 21479777

  • Lei X, Zhong M, Liu Y, Xi C, Ling Y, Zhu X, Yao S, Yi J. Psychometric properties of the 10-item ruminative response scale in Chinese university students. BMC Psychiatry. 2017 Apr 28;17(1):152. doi: 10.1186/s12888-017-1318-y.

    PubMed 28454569

  • Meng R, Yu Y, Chai S, Luo X, Gong B, Liu B, Hu Y, Luo Y, Yu C. Examining psychometric properties and measurement invariance of a Chinese version of the Self-Compassion Scale - Short Form (SCS-SF) in nursing students and medical workers. Psychol Res Behav Manag. 2019 Aug 30;12:793-809. doi: 10.2147/PRBM.S216411. eCollection 2019.

    PubMed 31565007

  • Montero-Marin J, Taylor L, Crane C, Greenberg MT, Ford TJ, Williams JMG, Garcia-Campayo J, Sonley A, Lord L, Dalgleish T, Blakemore SJ; MYRIAD team; Kuyken W. Teachers "Finding Peace in a Frantic World": An Experimental Study of Self-Taught and Instructor-Led Mindfulness Program Formats on Acceptability, Effectiveness, and Mechanisms. J Educ Psychol. 2021 Nov;113(8):1689-1708. doi: 10.1037/edu0000542. Epub 2021 Oct 18.

    PubMed 34912129

  • Ni MY, Li TK, Yu NX, Pang H, Chan BH, Leung GM, Stewart SM. Normative data and psychometric properties of the Connor-Davidson Resilience Scale (CD-RISC) and the abbreviated version (CD-RISC2) among the general population in Hong Kong. Qual Life Res. 2016 Jan;25(1):111-6. doi: 10.1007/s11136-015-1072-x. Epub 2015 Jul 22.

    PubMed 26198665

  • Smit D, Miguel C, Vrijsen JN, Groeneweg B, Spijker J, Cuijpers P. The effectiveness of peer support for individuals with mental illness: systematic review and meta-analysis. Psychol Med. 2023 Aug;53(11):5332-5341. doi: 10.1017/S0033291722002422. Epub 2022 Sep 6.

    PubMed 36066104

  • Tomasino KN, Lattie EG, Ho J, Palac HL, Kaiser SM, Mohr DC. Harnessing Peer Support in an Online Intervention for Older Adults with Depression. Am J Geriatr Psychiatry. 2017 Oct;25(10):1109-1119. doi: 10.1016/j.jagp.2017.04.015. Epub 2017 May 3.

    PubMed 28571785

  • Tong X, An D, McGonigal A, Park SP, Zhou D. Validation of the Generalized Anxiety Disorder-7 (GAD-7) among Chinese people with epilepsy. Epilepsy Res. 2016 Feb;120:31-6. doi: 10.1016/j.eplepsyres.2015.11.019. Epub 2015 Nov 28.

    PubMed 26709880

  • Wang W, Bian Q, Zhao Y, Li X, Wang W, Du J, Zhang G, Zhou Q, Zhao M. Reliability and validity of the Chinese version of the Patient Health Questionnaire (PHQ-9) in the general population. Gen Hosp Psychiatry. 2014 Sep-Oct;36(5):539-44. doi: 10.1016/j.genhosppsych.2014.05.021. Epub 2014 Jun 6.

    PubMed 25023953

  • Wang YH, Wang YL, Leung DKY, Ng ZLY, Chan OLH, Wong SMY, Chan RCL, Liu T, Wong GHY, Lum TYS. Effectiveness of an age-modified mindfulness-based cognitive therapy (MBCT) in improving mental health in older people with depressive symptoms: a non-randomised controlled trial. BMC Complement Med Ther. 2025 Feb 26;25(1):81. doi: 10.1186/s12906-025-04781-6.

    PubMed 40011881

  • Wong, S. M. Y., Lam, B. Y. H., Wong, C. S. M., Lee, H. P. Y., Wong, G. H. Y., Lui, S. S. Y., Chan, K. T., Wong, M. T. H., Chan, S. K. W., Chang, W. C., Lee, E. H. M., Suen, Y. N., Hui, C. L. M., & Chen, E. Y. H. (2021). Measuring subjective stress among young people in Hong Kong: Validation and predictive utility of the single-item subjective level of stress (SLS-1) in epidemiological and longitudinal community samples. Epidemiology and Psychiatric Sciences, 30, e61. https://doi.org/10.1017/S2045796021000445

  • Zhang, J. X., & Schwarzer, R. (1995). Measuring optimistic self-beliefs: A Chinese adaptation of the General Self-Efficacy Scale. Psychologia: An International Journal of Psychology in the Orient, 38(3), 174-181.

  • DeSalvo KB, Bloser N, Reynolds K, He J, Muntner P. Mortality prediction with a single general self-rated health question. A meta-analysis. J Gen Intern Med. 2006 Mar;21(3):267-75. doi: 10.1111/j.1525-1497.2005.00291.x. Epub 2005 Dec 7.

    PubMed 16336622

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-based intervention (MBI) (enhanced with peer supporters) and Experimental: social worker-led MBI (without peer supporters) in people with Depressive Symptoms, run by The University of Hong Kong at 13 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dara KY Leung, PhD (3917-0081, daralky@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline depression at Week 6 and Week 18 (time frame: Baseline and Week 6, Week 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06528132, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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