Mindfulness-Based Cognitive Therapy in Older People

March 29, 2024 updated by: Professor Terry Y.S. Lum, The University of Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
MBCT combines mindfulness meditation with cognitive behavioural therapy (CBT) elements to reduce or prevent recurrent major depressive disorders.
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)
MBCT combines mindfulness meditation with cognitive behavioural therapy (CBT) elements to reduce or prevent recurrent major depressive disorders.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline depression at Week 8
Time Frame: Baseline and 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
Time Frame: Baseline and 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
Time Frame: Baseline and 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
Time Frame: Baseline and 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
Time Frame: Baseline and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline depression at Week 12
Time Frame: Baseline and 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.
Baseline and Week 12
Change from baseline anxiety at Week 12
Time Frame: Baseline and 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.
Baseline and Week 12
Change from baseline stress at Week 12
Time Frame: Baseline and 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.
Baseline and Week 12
Change from baseline mindfulness at Week 12
Time Frame: Baseline and 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.
Baseline and Week 12
Change from baseline psychological flexibility at Week 12
Time Frame: Baseline and 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.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

The Hong Kong Jockey Club Charities Trust
Caritas Medical Centre, Hong Kong
The Salvation Army, Hong Kong and Macau Command
The Mental Health Association of Hong Kong
Christian Family Service Centre
Haven of Hope Hospital

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2022

Primary Completion (Actual)

October 4, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA220105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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