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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02667782
Enrollment
53
Registered
2016-01-29
Start date
2016-02-18
Completion date
2017-09-30
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Dependency Burden, Stress, Psychological

Keywords

Mindfulness-based interventions, Dementia, Caregiving, Burden, Stress, Anxiety, Depression, Community care

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.

Interventions

BEHAVIORALMindfulness-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.

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.

Sponsors

Griffith University
CollaboratorOTHER
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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).

Design outcomes

Primary

MeasureTime frameDescription
Change of Perceived Stress Scale (PSS)[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: 1. T0 - T1 2. T0 - T2 3. T0 - T3 4. T1 - T2 5. T1 - T3 6. T2 - T3

Secondary

MeasureTime frameDescription
Change of Hospital Anxiety and Depression Scale (HADS)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: 1. T0 - T1 2. T0 - T2 3. T0 - T3 4. T1 - T2 5. T1 - T3 6. T2 - T3
Center for Epidemiologic Studies Depression Scale (CESD)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: 1. T0 - T1 2. T0 - T2 3. T0 - T3 4. T1 - T2 5. T1 - T3 6. T2 - T3
Zarit Burden Inventory (ZBI)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: 1. T0 - T1 2. T0 - T2 3. T0 - T3 4. T1 - T2 5. T1 - T3 6. T2 - T3

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026