Clinical trial NCT05995587: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: Mindfulness-based cognitive therapy
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
name: Christian Family Service Centre
name: The Mental Health Association of Hong Kong
name: The Salvation Army, Hong Kong and Macau Command
name: Caritas Medical Centre, Hong Kong
name: Haven of Hope Hospital
First posted: 2023-08-16
Enrollment: 112
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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. 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.

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.

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

Primary outcomes:
measure: Change from baseline depression at Week 8
timeFrame: Baseline and Week 8
measure: Change from baseline anxiety at Week 8
timeFrame: Baseline and Week 8
measure: Change from baseline stress at Week 8
timeFrame: Baseline and Week 8
measure: Change from baseline mindfulness at Week 8
timeFrame: Baseline and Week 8
measure: Change from baseline psychological flexibility at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
Other outcomes:
measure: Change from baseline depression at Week 12
timeFrame: Baseline and Week 12
measure: Change from baseline anxiety at Week 12
timeFrame: Baseline and Week 12
measure: Change from baseline stress at Week 12
timeFrame: Baseline and Week 12
measure: Change from baseline mindfulness at Week 12
timeFrame: Baseline and Week 12
measure: Change from baseline psychological flexibility at Week 12
timeFrame: Baseline and Week 12
Locations:
city: Kwun Tong
country: Hong Kong
facility: Amity Place (Kwun Tong Central)
city: Kwun Tong
country: Hong Kong
facility: Shun On District Elderly Community Centre (DECC)
city: Sai Kung
country: Hong Kong
facility: Haven of Hope District Elderly Community Service
city: Sai Kung
country: Hong Kong
facility: Wellness Zone - Integrated Community Centre for Mental Wellness
city: Sham Shui Po
country: Hong Kong
facility: Caritas Cheng Shing Fung District Elderly Centre (Sham Shui Po)
city: Tai Po
country: Hong Kong
facility: Tai Po Multi-service Centre for Senior Citizens
Study officials:
affiliation: Department of Social Work and Social Administration, The University of Hong Kong
name: Terry Lum, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Social Work and Social Administration, The University of Hong Kong
name: Gloria Wong, PhD
role: PRINCIPAL_INVESTIGATOR
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