Mindfulness-Based Cognitive Therapy in Older People
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| ClinicalTrials.gov Identifier: NCT05995587 |
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Recruitment Status :
Completed
First Posted : August 16, 2023
Last Update Posted : April 1, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depressive Symptoms | Behavioral: Mindfulness-based cognitive therapy (MBCT) | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 112 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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) |
| Primary Purpose: | Treatment |
| Official Title: | Mindfulness-Based Cognitive Therapy in Managing Depressive Symptoms in Older People: A Non-Randomised Controlled Trial |
| Actual Study Start Date : | May 31, 2022 |
| Actual Primary Completion Date : | October 4, 2023 |
| Actual Study Completion Date : | November 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: MBCT (mindfulness teacher)
Participants in the MBCT (mindfulness teacher) group will receive mindfulness training from a certified mindfulness teacher.
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Behavioral: Mindfulness-based cognitive therapy (MBCT)
MBCT combines mindfulness meditation with cognitive behavioural therapy (CBT) elements to reduce or prevent recurrent major depressive disorders. |
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Experimental: MBCT (social workers)
Participants in the MBCT (social workers) group will receive mindfulness training from social workers (supervised by a certified mindfulness teacher).
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Behavioral: Mindfulness-based cognitive therapy (MBCT)
MBCT combines mindfulness meditation with cognitive behavioural therapy (CBT) elements to reduce or prevent recurrent major depressive disorders. |
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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).
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05995587
| Hong Kong | |
| Amity Place (Kwun Tong Central) | |
| Kwun Tong, Hong Kong | |
| Shun On District Elderly Community Centre (DECC) | |
| Kwun Tong, Hong Kong | |
| Haven of Hope District Elderly Community Service | |
| Sai Kung, Hong Kong | |
| Wellness Zone - Integrated Community Centre for Mental Wellness | |
| Sai Kung, Hong Kong | |
| Caritas Cheng Shing Fung District Elderly Centre (Sham Shui Po) | |
| Sham Shui Po, Hong Kong | |
| Tai Po Multi-service Centre for Senior Citizens | |
| Tai Po, Hong Kong | |
| 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 |
Documents provided by Professor Terry Y.S. Lum, The University of Hong Kong:
| Responsible Party: | Professor Terry Y.S. Lum, Professor, The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT05995587 |
| Other Study ID Numbers: |
EA220105 |
| First Posted: | August 16, 2023 Key Record Dates |
| Last Update Posted: | April 1, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Mindfulness-based cognitive therapy |
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Depression Behavioral Symptoms |