Mindfulness-Based Cognitive Therapy in Older People

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Behavioral: Mindfulness-based cognitive therapy (MBCT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCT (mindfulness teacher)<br>Participants in the MBCT (mindfulness teacher) group will receive mindfulness training from a certified mindfulness teacher. | Behavioral: Mindfulness-based cognitive therapy (MBCT)<br>* MBCT combines mindfulness meditation with cognitive behavioural therapy (CBT) elements to reduce or prevent recurrent major depressive disorders.<br>|
| Experimental: MBCT (social workers)<br>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)<br>* MBCT combines mindfulness meditation with cognitive behavioural therapy (CBT) elements to reduce or prevent recurrent major depressive disorders.<br>|
| No Intervention: Care as usual group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness-based cognitive therapy