AzTrials
AzTrials

Depressive SymptomsNCT05995587

Mindfulness-Based Cognitive Therapy in Older People

A study testing Mindfulness-based cognitive therapy (MBCT) in people with Depressive Symptoms, run by The University of Hong Kong at 6 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. 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 cognitive therapy (MBCT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
6 sitesHong Kong
Study dates
31 May 2022to 30 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

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 or more in 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
  • imminent suicidal risk
  • difficulty in communication

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Hong Kong6 sites
  • Amity Place (Kwun Tong Central)

    Kwun Tong

  • Shun On District Elderly Community Centre (DECC)

    Kwun Tong

  • Haven of Hope District Elderly Community Service

    Sai Kung

  • Wellness Zone - Integrated Community Centre for Mental Wellness

    Sai Kung

  • Caritas Cheng Shing Fung District Elderly Centre (Sham Shui Po)

    Sham Shui Po

  • Tai Po Multi-service Centre for Senior Citizens

    Tai Po

Other trials in Hong Kong

About this study

Official title: Mindfulness-Based Cognitive Therapy in Managing Depressive Symptoms in Older People: A Non-Randomised Controlled Trial

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.

Being tested
Mindfulness-based cognitive therapy (MBCT)
Keywords
Mindfulness-based cognitive therapy
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 cognitive therapy (MBCT)Behavioural

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

Study groups in NCT05995587
Study groupRoleWhat they receive
MBCT (mindfulness teacher)ExperimentalParticipants in the MBCT (mindfulness teacher) group will receive mindfulness training from a certified mindfulness teacher.
Receives: Behavioral: Mindfulness-based cognitive therapy (MBCT)
MBCT (social workers)ExperimentalParticipants in the MBCT (social workers) group will receive mindfulness training from social workers (supervised by a certified mindfulness teacher).
Receives: Behavioral: Mindfulness-based cognitive therapy (MBCT)
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 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and Week 8

Timeline

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

  1. First posted16 Aug 2023
  2. Study start31 May 2022
  3. Primary completion4 Oct 2023
  4. Study completion30 Nov 2023

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
Non-randomised
Intervention model
Parallel groups
Model description
Participants in the intervention group will either receive mindfulness training from a certified mindfulness teacher or from social workers (supervised by a certified mindfulness teacher). 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
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05995587
Sponsor's protocol ID
EA220105
Status last verified
Mar 2024
First submitted
8 Aug 2023
Last updated
1 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-based cognitive therapy (MBCT) in people with Depressive Symptoms, run by The University of Hong Kong at 6 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 3 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: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline depression at Week 8 (time frame: Baseline and Week 8). The study lists 5 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 NCT05995587, which also lists 11 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 1 Apr 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in