Clinical trial NCT02667782: Feasibility Study on the Use of Mindfulness-based Intervention for Family Carers of People With Dementia
Official title: Use of a Mindfulness-based Intervention for Family Carers of People With Dementia in the Community: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Dependency Burden
Stress, Psychological
Keywords: Mindfulness-based interventions
Dementia
Caregiving
Burden
Stress
Anxiety
Depression
Community care
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Griffith University
First posted: 2016-01-29
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change of Perceived Stress Scale (PSS)
timeFrame: [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 outcomes:
measure: Change of Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3).
measure: Center for Epidemiologic Studies Depression Scale (CESD)
timeFrame: At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3).
measure: Zarit Burden Inventory (ZBI)
timeFrame: At baseline (T0), 2 months (mid-point of intervention; T1), 4 months (immediately post- intervention; T2), and 7 months (follow-up assessment; T3).
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic University
city: Kowloon
country: Hong Kong
facility: Community care centres
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Wai Tong Chien, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Griffith University
name: Wendy Moyle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Daphne Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cullen M. (2011). Mindfulness- Based Interventions: an Emerging Phenomenon. Mindfulness. 2(3):186-93.
citation: Cohen, S. and Williamson, G. Perceived Stress in a Probability Sample of the United States. Spacapan, S. and Oskamp, S. (Eds.) The Social Psychology of Health. Newbury Park, CA: Sage, 1988
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
citation: Radloff, L. S. (1977). The CES-D scale: A self report depression scale for research in the general population. Applied Psychological Measurements, 1, 385-401.
citation: Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
citation: Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
citation: Segal Z. V., Williams J. M. G., & Teasdale J. D. (2002). Mindfulness-based cognitive therapy for depression: A new approach to preventing relapse. New York: Guilford.
citation: Kabat-Zinn, J. (1990). Full Catastrophe Living: How to Cope with Stress, Pain and Illness Using Mindfulness Meditation. New York, NY: Delacorte.