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CompletedNCT05995587Updated Apr 1, 2024

Mindfulness-Based Cognitive Therapy in Older People

An interventional study of Mindfulness-based cognitive therapy (MBCT) in Depressive Symptoms, sponsored by The University of Hong Kong. Completed at 6 sites in Hong Kong. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-04-01.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled May 2022, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Non-randomized
Ages
60 Years and older
Sex
All
01

Study summary

Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), have the potential in improving psychological health in older people. With the growing older people population, there is a need for greater social welfare capacity to promote their well-being. The project aims to:

  1. Evaluate the effectiveness of MBCT in improving mental health and mindfulness in older people with depressive symptoms as compared to care as usual;
  2. Compare the effectiveness between MBCT led by mindfulness teacher and that led by social workers;
  3. Examine psychological flexibility as a potential mechanism of change in MBCT for depressive symptoms.
Read the detailed description

Depression is one of the most common yet under-recognized mental disorders in older adults in Hong Kong, and it is estimated that approximately one in 10 older people has clinically significant depression. With population aging, the number of older people with depression is slated to double in the next two decades, creating a substantial burden on the individuals, caregivers, and health care system. While pharmacological interventions are effective in reducing depression, medical risks can be complicated due to polypharmacy in older people. Non-pharmacological interventions may benefit the population by addressing the underlying dysfunctional cognitive processes associated with depression.

Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), have the potential in improving psychological health in older people. MBCT is a group intervention originally designed to prevent recurrent depressive disorders. It combines mindfulness practices and cognitive-behavioural elements to enhance an individual's understanding of the interacting relationships among thoughts, emotions, bodily sensations, and behaviours. Mindfulness practice emphasizes on developing a moment-to-moment, non-judgmental awareness and may be helpful in alleviating depression by directing individual's attention to the present instead of ruminating in the past. Systematic reviews have shown the efficacy of MBCT in reducing depression, anxiety, loneliness, stress, sleep problems, ruminations, general mood, and positive affect. However, over half of the included studies lacked a control group and mixed findings were observed possibly because of inconsistent modifications to the protocol, methodological flaws, and study limitations.

The application of MBCT in the Chinese older population is understudied. Recently, a randomized controlled trial on MBCT for older people were conducted in Hong Kong. By comparing a standard MBCT to an active control group (physical exercise + health education) for older people with depression, it has been found that while both groups showed a reduction in the severity of depressive symptoms, only the MBCT group showed improvement in mindfulness.

With these promising findings, more studies are needed to establish the evidence base for the intervention and inform clinical practice in this population. The investigators aim to explore whether a modified MBCT based on older people's feedback can reduce depressive symptoms and improve mindfulness. With the growing older people population and thus a need for greater social welfare capacity to promote their well-being, the investigators will also examine whether a modified MBCT led by social workers under the supervision of a mindfulness teacher can benefit the population.

02

Conditions studied

  • Depressive Symptoms

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Keywords

  • Mindfulness-based cognitive therapy
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 112 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia
  • imminent suicidal risk
  • difficulty in communication
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    MBCT (mindfulness teacher)

    Participants in the MBCT (mindfulness teacher) group will receive mindfulness training from a certified mindfulness teacher.

    Behavioral: Mindfulness-based cognitive therapy (MBCT)

  • Experimental
    MBCT (social workers)

    Participants in the MBCT (social workers) group will receive mindfulness training from social workers (supervised by a certified mindfulness teacher).

    Behavioral: Mindfulness-based cognitive therapy (MBCT)

  • 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).

Interventions

  • BehavioralMindfulness-based cognitive therapy (MBCT)

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

06

What researchers measure

Primary outcomes

  1. Change from baseline depression at Week 8

    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.

    Time frame: Baseline and Week 8

  2. Change from baseline anxiety at Week 8

    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.

    Time frame: Baseline and Week 8

  3. Change from baseline stress at Week 8

    Stress will be measured by the Chinese validated Perceived Stress Scale (PSS). The total score will be used, ranging from 0 to 40. Higher scores indicate greater stress.

    Time frame: Baseline and Week 8

  4. Change from baseline mindfulness at Week 8

    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 total score (ranging from 4 to 20) of the five subscales (i.e., observe, describe, acting with awareness, nondjuding, and nonreactivity) will be used. Higher scores indicate higher mindfulness.

    Time frame: Baseline and Week 8

  5. Change from baseline psychological flexibility at Week 8

    Psychological flexibility will be assessed by the Chinese version of the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT). Items are rated on a 0 (strongly disagree) to 6 (strongly agree) scale. The total score of the CompAct scale (ranging from 0 to 48), Valued Action subscale (ranging 0 to 18), Openness to Experience subscale (ranging from 0 to 18), and Behavioural Awareness subscale (ranging from 0 to 12) will be used. Higher scores indicate greater psychological flexibility.

    Time frame: Baseline and Week 8

Other outcomes

  1. Change from baseline depression at Week 12

    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.

    Time frame: Baseline and Week 12

  2. Change from baseline anxiety at Week 12

    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.

    Time frame: Baseline and Week 12

  3. Change from baseline stress at Week 12

    Stress will be measured by the Chinese validated Perceived Stress Scale (PSS). The total score will be used, ranging from 0 to 40. Higher scores indicate greater stress.

    Time frame: Baseline and Week 12

  4. Change from baseline mindfulness at Week 12

    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 total score (ranging from 4 to 20) of the five subscales (i.e., observe, describe, acting with awareness, nondjuding, and nonreactivity) will be used. Higher scores indicate higher mindfulness.

    Time frame: Baseline and Week 12

  5. Change from baseline psychological flexibility at Week 12

    Psychological flexibility will be assessed by the Chinese version of the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT). Items are rated on a 0 (strongly disagree) to 6 (strongly agree) scale. The total score of the CompAct scale (ranging from 0 to 48), Valued Action subscale (ranging 0 to 18), Openness to Experience subscale (ranging from 0 to 18), and Behavioural Awareness subscale (ranging from 0 to 12) will be used. Higher scores indicate greater psychological flexibility.

    Time frame: Baseline and Week 12

07

Study locations

6 sites
  • Amity Place (Kwun Tong Central)
    Kwun Tong, Hong Kong
  • Shun On District Elderly Community Centre (DECC)
    Kwun Tong, Hong Kong
  • Haven of Hope District Elderly Community Service
    Sai Kung, Hong Kong
  • Wellness Zone - Integrated Community Centre for Mental Wellness
    Sai Kung, Hong Kong
  • Caritas Cheng Shing Fung District Elderly Centre (Sham Shui Po)
    Sham Shui Po, Hong Kong
  • Tai Po Multi-service Centre for Senior Citizens
    Tai Po, Hong Kong
08

References and documents

Publications

  • Geiger PJ, Boggero IA, Brake CA, Caldera CA, Combs HL, Peters JR, Baer RA. Mindfulness-Based Interventions for Older Adults: A Review of the Effects on Physical and Emotional Well-being. Mindfulness (N Y). 2016 Apr;7(2):296-307. doi: 10.1007/s12671-015-0444-1. Epub 2015 Sep 14. PubMed 27200109 ↗
  • Hou J, Wong SY, Lo HH, Mak WW, Ma HS. Validation of a Chinese version of the Five Facet Mindfulness Questionnaire in Hong Kong and development of a short form. Assessment. 2014 Jun;21(3):363-71. doi: 10.1177/1073191113485121. Epub 2013 Apr 16. PubMed 23596271 ↗
  • Ng SM. Validation of the 10-item Chinese perceived stress scale in elderly service workers: one-factor versus two-factor structure. BMC Psychol. 2013 Jun 19;1(1):9. doi: 10.1186/2050-7283-1-9. eCollection 2013. PubMed 25566361 ↗
  • Shih VWY, Chan WC, Tai OK, Wong HL, Cheng CPW, Wong CSM. Mindfulness-Based Cognitive Therapy for Late-Life Depression: a Randomised Controlled Trial. East Asian Arch Psychiatry. 2021 Jun;31(2):27-35. doi: 10.12809/eaap2075. PubMed 34987115 ↗
  • Sun WJ, Xu L, Chan WM, Lam TH, Schooling CM. Depressive symptoms and suicide in 56,000 older Chinese: a Hong Kong cohort study. Soc Psychiatry Psychiatr Epidemiol. 2012 Apr;47(4):505-14. doi: 10.1007/s00127-011-0362-z. Epub 2011 Mar 8. PubMed 21384121 ↗
  • 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 ↗
  • Thomas, R., Chur-Hansen, A. & Turner, M. A Systematic Review of Studies on the Use of Mindfulness-Based Cognitive Therapy for the Treatment of Anxiety and Depression in Older People. Mindfulness 11, 1599-1609 (2020). https://doi.org/10.1007/s12671-020-01336-3
  • Morris, J. (2019). Development and validation of a short form of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT-SF). University of Nottingham.
  • Segal, Z. V., Williams, J. M. G., & Teasdale, J. D. (2012). Mindfulness-based cognitive therapy for depression. Guilford Press.

Study documents

  • Protocol and statistical analysis plan · Aug 8, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05995587
Lead sponsor
The University of Hong Kong
Collaborators
The Hong Kong Jockey Club Charities Trust, Christian Family Service Centre, The Mental Health Association of Hong Kong, The Salvation Army, Hong Kong and Macau Command, Caritas Medical Centre, Hong Kong, Haven of Hope Hospital
Responsible party
Professor Terry Y.S. Lum (Professor, The University of Hong Kong) — Principal investigator
First posted
Aug 16, 2023
Start date
May 31, 2022
Primary completion
Oct 4, 2023
Completion
Nov 30, 2023
Last update
Apr 1, 2024

Study contacts

Terry Lum, PhD
principal investigator · Department of Social Work and Social Administration, The University of Hong Kong
Gloria Wong, PhD
principal investigator · Department of Social Work and Social Administration, The University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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