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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stress, Psychological; Anxiety; Dependency Burden
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction (MBSR); Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • School of Nursing, The Hong Kong Polytechnic University
  • Kowloon, Hong Kong
    • Community care centres

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Stress Reduction; 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); 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.
Experimental: Mindfulness-Based Cognitive Therapy; 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); 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.

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Griffith University
• Investigators: Principal Investigator: Wendy Moyle, PhD, Griffith University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Cullen M. (2011). Mindfulness- Based Interventions: an Emerging Phenomenon. Mindfulness. 2(3):186-93.
• 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
• 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.
• 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.
• Kabat-Zinn, J. (1990). Full Catastrophe Living: How to Cope with Stress, Pain and Illness Using Mindfulness Meditation. New York, NY: Delacorte.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2016
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Stress; Dementia; Burden; Caregiving; Mindfulness-based interventions; Community care
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Depression; Stress, Psychological; Dementia
• Other Study ID Numbers: 1-ZVG9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No