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Mindfulness-Based Cognitive Therapy in Older People

Primary Purpose

Depressive Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Mindfulness-based cognitive therapy (MBCT)
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Mindfulness-based cognitive therapy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amity Place (Kwun Tong Central)Recruiting
  • Shun On District Elderly Community Centre (DECC)Recruiting
  • Haven of Hope District Elderly Community ServiceRecruiting
  • Wellness Zone - Integrated Community Centre for Mental WellnessRecruiting
  • Caritas Cheng Shing Fung District Elderly Centre (Sham Shui Po)Recruiting
  • Tai Po Multi-service Centre for Senior CitizensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

MBCT (mindfulness teacher)

MBCT (social workers)

Care as usual group

Arm Description

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

Participants in the MBCT (social workers) group will receive mindfulness training 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).

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2023
Last Updated
August 15, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05995587
Brief Title
Mindfulness-Based Cognitive Therapy in Older People
Official Title
Mindfulness-Based Cognitive Therapy in Managing Depressive Symptoms in Older People: A Non-Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
October 4, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
Mindfulness-based cognitive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MBCT (mindfulness teacher)
Arm Type
Experimental
Arm Description
Participants in the MBCT (mindfulness teacher) group will receive mindfulness training from a certified mindfulness teacher.
Arm Title
MBCT (social workers)
Arm Type
Experimental
Arm Description
Participants in the MBCT (social workers) group will receive mindfulness training from social workers (supervised by a certified mindfulness teacher).
Arm Title
Care as usual group
Arm Type
No Intervention
Arm Description
The care as usual group will receive usual service provided in District Elderly Community Centres (DECC) and Integrated Community Centre for Mental Wellness (ICCMW).
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based cognitive therapy (MBCT)
Intervention Description
MBCT combines mindfulness meditation with cognitive behavioural therapy (CBT) elements to reduce or prevent recurrent major depressive disorders.
Primary Outcome Measure Information:
Title
Change from baseline depression at Week 8
Description
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
Title
Change from baseline anxiety at Week 8
Description
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
Title
Change from baseline stress at Week 8
Description
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
Title
Change from baseline mindfulness at Week 8
Description
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
Title
Change from baseline psychological flexibility at Week 8
Description
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 Pre-specified Outcome Measures:
Title
Change from baseline depression at Week 12
Description
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
Title
Change from baseline anxiety at Week 12
Description
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
Title
Change from baseline stress at Week 12
Description
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
Title
Change from baseline mindfulness at Week 12
Description
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
Title
Change from baseline psychological flexibility at Week 12
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia imminent suicidal risk difficulty in communication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun-Lin Wang, PhD
Phone
+852-3917-5594
Email
yunlinw@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Yun-Han Wang, PhD
Phone
+852-3917-1755
Email
yunhanw@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Lum, PhD
Organizational Affiliation
Department of Social Work and Social Administration, The University of Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gloria Wong, PhD
Organizational Affiliation
Department of Social Work and Social Administration, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amity Place (Kwun Tong Central)
City
Kwun Tong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
May Kou
Phone
+852-2346-3798
Email
maykou@mhahk.org.hk
Facility Name
Shun On District Elderly Community Centre (DECC)
City
Kwun Tong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwai Yee Lau
Phone
+852-2727-1234
Email
kwaiyee_lau@cfsc.org.hk
Facility Name
Haven of Hope District Elderly Community Service
City
Sai Kung
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pui Ling Cheng
Phone
+852-2702-1113
Email
plcheng@hohcs.org.hk
Facility Name
Wellness Zone - Integrated Community Centre for Mental Wellness
City
Sai Kung
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chak Ling Lee
Phone
+852-2706-7198
Email
cl_lee@cfsc.org.hk
Facility Name
Caritas Cheng Shing Fung District Elderly Centre (Sham Shui Po)
City
Sham Shui Po
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Yee Kwan
Phone
+852-2729-1211
Email
kwanjoyce@caritassws.org.hk
Facility Name
Tai Po Multi-service Centre for Senior Citizens
City
Tai Po
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wai Man Lau
Phone
+852-2653-6811
Email
WaiMan.Lau@hkm.salvationarmy.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27200109
Citation
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.
Results Reference
background
PubMed Identifier
23596271
Citation
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.
Results Reference
background
PubMed Identifier
25566361
Citation
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.
Results Reference
background
PubMed Identifier
34987115
Citation
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.
Results Reference
background
PubMed Identifier
21384121
Citation
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.
Results Reference
background
PubMed Identifier
26709880
Citation
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.
Results Reference
background
PubMed Identifier
25023953
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
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.
Results Reference
background
Citation
Segal, Z. V., Williams, J. M. G., & Teasdale, J. D. (2012). Mindfulness-based cognitive therapy for depression. Guilford Press.
Results Reference
background

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Mindfulness-Based Cognitive Therapy in Older People

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