NCT05995587

Brief 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. 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. 2.Compare the effectiveness between MBCT led by mindfulness teacher and that led by social workers;
  3. 3.Examine psychological flexibility as a potential mechanism of change in MBCT for depressive symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

August 8, 2023

Last Update Submit

March 29, 2024

Conditions

Keywords

Mindfulness-based cognitive therapy

Outcome Measures

Primary Outcomes (5)

  • 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.

    Baseline and Week 8

  • 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.

    Baseline and Week 8

  • 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.

    Baseline and Week 8

  • 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.

    Baseline and Week 8

  • 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.

    Baseline and Week 8

Other Outcomes (5)

  • Change from baseline depression at Week 12

    Baseline and Week 12

  • Change from baseline anxiety at Week 12

    Baseline and Week 12

  • Change from baseline stress at Week 12

    Baseline and Week 12

  • +2 more other outcomes

Study Arms (3)

MBCT (mindfulness teacher)

EXPERIMENTAL

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

Behavioral: Mindfulness-based cognitive therapy (MBCT)

MBCT (social workers)

EXPERIMENTAL

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)

Care as usual group

NO INTERVENTION

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

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

MBCT (mindfulness teacher)MBCT (social workers)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Amity Place (Kwun Tong Central)

Kwun Tong, Hong Kong

Location

Shun On District Elderly Community Centre (DECC)

Kwun Tong, Hong Kong

Location

Haven of Hope District Elderly Community Service

Sai Kung, Hong Kong

Location

Wellness Zone - Integrated Community Centre for Mental Wellness

Sai Kung, Hong Kong

Location

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

Sham Shui Po, Hong Kong

Location

Tai Po Multi-service Centre for Senior Citizens

Tai Po, Hong Kong

Location

Related Publications (11)

  • 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.

    PMID: 27200109BACKGROUND
  • 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.

    PMID: 23596271BACKGROUND
  • 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.

    PMID: 25566361BACKGROUND
  • 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.

    PMID: 34987115BACKGROUND
  • 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.

    PMID: 21384121BACKGROUND
  • 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.

    PMID: 26709880BACKGROUND
  • 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.

    PMID: 25023953BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • Segal, Z. V., Williams, J. M. G., & Teasdale, J. D. (2012). Mindfulness-based cognitive therapy for depression. Guilford Press.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Depression

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Terry Lum, PhD

    Department of Social Work and Social Administration, The University of Hong Kong

    PRINCIPAL INVESTIGATOR
  • Gloria Wong, PhD

    Department of Social Work and Social Administration, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 16, 2023

Study Start

May 31, 2022

Primary Completion

October 4, 2023

Study Completion

November 30, 2023

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations