Feasibility Study on the Use of Mindfulness-based Intervention for Family Carers of People With Dementia

Study Overview
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Brief Summary
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The aim of this study is to examine which mindfulness-based intervention protocol, MBCT or MBSR, is more suited for use among local carers of people with dementia (PWD), as measured by better mental health outcomes in PWD such as reductions in stress and improvements in mental well-being.

Detailed Description
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60 subjects will be recruited in the community and randomized into either the MBCT or MBSR group. Both MBSR and MBCT will be delivered through a face-to-face teaching session followed by regular telephone follow-ups. The primary outcome measures of the dementia caregivers will be stress with Perceived Stress Scale (PSS; Cohen & Williamson, 1988). The secondary outcome measures of the dementia caregiver will be 1) anxiety with Hospital Anxiety and Depression Scale (HADS; Zigmon & Snaith, 1983), 2) depression with Center for Epidemiologic Studies Depression Scale (CESD; Radloff, 1977), and 3) burden with Zarit Burden Inventory (ZBI; Zarit, Reever, & Bach-Peterson, 1980). The control measure will be their level of mastery of the five facets mindfulness with Five Facets Mindfulness Questionnaire (FFMQ; Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006). Focus group interviews with each group of participants will be conducted post-intervention to explore their experiences and perceptions. Data will be collected at baseline (T0), at 2 months (the mid-point of the intervention; T1), 4 months (immediately after the intervention; T2), and 7 months (the follow-up assessment; T3). Adherence rates, response rates, and drop-out rates will be collected and analyzed. The triangulation of both qualitative and quantitative data will be performed to determine the suitability and benefits of MBSR and MBCT for carers of PWD in the local setting.

Official Title
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Use of a Mindfulness-based Intervention for Family Carers of People With Dementia in the Community: A Feasibility Study

Conditions
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Anxiety, Depression, Dependency Burden, Stress, Psychological

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction (MBSR)
* Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)


Participation Criteria
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Eligibility Criteria
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one participant (family carer) for each PWD (dementia of any type) living in the community Inclusion Criteria for the family carer: is the primary carer of an adult with a confirmed diagnosis of dementia. Exclusion Criteria: has a major active psychiatric illness such as bipolar disorder or schizophrenia. is currently undergoing cancer treatment. has severe chronic pain (lasting more than six months).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Stress Reduction<br>Mindfulness-Based Stress Reduction (MBSR) is developed by Jon Kabat-Zinn in 1979 (Kabat-Zinn, 1990). It is an eight-week Program that includes practices such as gentle mindful movement (awareness of the body), a body scan (to systematically nurture awareness of the body region by region), and sitting meditation (awareness of the breath to include the four foundations of mindfulness, namely, body, feeling tone, mental state, and mental content) (Cullen, 2011). | Behavioral: Mindfulness-Based Stress Reduction (MBSR)<br>* Recruited subjects that are randomly allocated into the MBSR group will have an intensive face-to-face (F-T-F) teaching-learning program that is focused on stress reduction. After that, there will be some regular telephone follow-ups for a closed group of 10-15 participants. Subjects would receive four consecutive weekly F-T-F sessions, then a weekly telephone follow-up for three months in combination with an F-T-F session once a month. The Interventionist will be an experienced mindfulness therapist who is qualified to deliver both MBSR and MBCT.<br>|
| Experimental: Mindfulness-Based Cognitive Therapy<br>Mindfulness-Based Cognitive Therapy (MBCT), developed by Zindel Segal, Mark Williams and John Teasdale, employs a cognitive theoretical framework (Cullen, 2011; Segal, Williams, & Teasdale, 2002). It is also delivered as an eight-session group treatment. The first four sessions teach the fundamental concepts and skills of the practice of mindfulness. The remaining four sessions teach the individual how to notice his/her own thoughts and the impact of such thoughts on his/her own physical and emotional experiences. | Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)<br>* Recruited subjects that are randomly allocated into the MBCT group will have an intensive face-to-face (F-T-F) teaching-learning program that is focused on cognitive therapy. After that, there will be some regular telephone follow-ups for a closed group of 10-15 participants. Subjects would receive four consecutive weekly F-T-F sessions, then a weekly telephone follow-up for three months in combination with an F-T-F session once a month. The Interventionist will be an experienced mindfulness therapist who is qualified to deliver both MBSR and MBCT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Perceived Stress Scale (PSS) | Comparisons of changes of Perceived Stress Scale will be considered as follows: T0 - T1 T0 - T2 T0 - T3 T1 - T2 T1 - T3 T2 - T3 | [Time Frame: At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Hospital Anxiety and Depression Scale (HADS) | Comparisons of changes of Hospital Anxiety and Depression Scale will be considered as follows: T0 - T1 T0 - T2 T0 - T3 T1 - T2 T1 - T3 T2 - T3 | At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3). | 
| Center for Epidemiologic Studies Depression Scale (CESD) | Comparisons of changes of Center for Epidemiologic Studies Depression Scale will be considered as follows: T0 - T1 T0 - T2 T0 - T3 T1 - T2 T1 - T3 T2 - T3 | At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3). | 
| Zarit Burden Inventory (ZBI) | Comparisons of changes of Zarit Burden Inventory will be considered as follows: T0 - T1 T0 - T2 T0 - T3 T1 - T2 T1 - T3 T2 - T3 | At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness-based interventions, Dementia, Caregiving, Burden, Stress, Anxiety, Depression, Community care