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

Primary Purpose

Anxiety, Depression, Dependency Burden

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction (MBSR)
Mindfulness-Based Cognitive Therapy (MBCT)
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Mindfulness-based interventions, Dementia, Caregiving, Burden, Stress, Anxiety, Depression, Community care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mindfulness-Based Stress Reduction

Mindfulness-Based Cognitive Therapy

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
January 21, 2016
Last Updated
February 20, 2018
Sponsor
The Hong Kong Polytechnic University
Collaborators
Griffith University
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1. Study Identification

Unique Protocol Identification Number
NCT02667782
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 18, 2016 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Griffith University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Dependency Burden, Stress, Psychological
Keywords
Mindfulness-based interventions, Dementia, Caregiving, Burden, Stress, Anxiety, Depression, Community care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Experimental
Arm Description
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).
Arm Title
Mindfulness-Based Cognitive Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction (MBSR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive Therapy (MBCT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Perceived Stress Scale (PSS)
Description
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
[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 Measure Information:
Title
Change of Hospital Anxiety and Depression Scale (HADS)
Description
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
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).
Title
Center for Epidemiologic Studies Depression Scale (CESD)
Description
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
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).
Title
Zarit Burden Inventory (ZBI)
Description
Comparisons of changes of Zarit Burden Inventory 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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Tong Chien, PhD
Organizational Affiliation
School of Nursing, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wendy Moyle, PhD
Organizational Affiliation
Griffith University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daphne Cheung, PhD
Organizational Affiliation
School of Nursing, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Facility Name
Community care centres
City
Kowloon
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Cullen M. (2011). Mindfulness- Based Interventions: an Emerging Phenomenon. Mindfulness. 2(3):186-93.
Results Reference
background
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
Results Reference
background
PubMed Identifier
6880820
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
7203086
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.
Results Reference
background
PubMed Identifier
16443717
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.
Results Reference
background
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.
Results Reference
background
Citation
Kabat-Zinn, J. (1990). Full Catastrophe Living: How to Cope with Stress, Pain and Illness Using Mindfulness Meditation. New York, NY: Delacorte.
Results Reference
background

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

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