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Completed

NCT Number: NCT02667782

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Dependency Burden Depression Mental Disorders Nervous System Diseases Neurocognitive Disorders Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, The Hong Kong Polytechnic University, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mindfulness-Based Stress Reduction (MBSR)

Behavioral

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.

Mindfulness-based cognitive therapy (MBCT)

Behavioral

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 outcomes

  1. Change of Perceived Stress Scale (PSS)

    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).

    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 outcomes

  1. Change of Hospital Anxiety and Depression Scale (HADS)

    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).

    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

  2. Center for Epidemiologic Studies Depression Scale (CESD)

    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).

    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

  3. Zarit Burden Inventory (ZBI)

    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).

    Comparisons of changes of Zarit Burden Inventory will be considered as follows:

    • T0 - T1
    • T0 - T2
    • T0 - T3
    • T1 - T2
    • T1 - T3
    • T2 - T3

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Griffith University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 29, 2016
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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