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

NCT ID: NCT02667782

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-18
• Study Completion Date: 2017-09-30

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.

Conditions

Anxiety; Depression; Dependency Burden; Stress, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction (MBSR)

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Mindfulness-Based Cognitive Therapy (MBCT)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Griffith University

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Wai-Tong Chien

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wai Tong Chien, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, The Hong Kong Polytechnic University

Wendy Moyle, PhD

Role: PRINCIPAL_INVESTIGATOR

Griffith University

Daphne Cheung, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, The Hong Kong Polytechnic University

Locations

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Community care centres

Kowloon, , Hong Kong

Countries

Hong Kong

References

Cullen M. (2011). Mindfulness- Based Interventions: an Emerging Phenomenon. Mindfulness. 2(3):186-93.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 6880820 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 7203086 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16443717 (View on PubMed)

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.

Reference Type: BACKGROUND

Kabat-Zinn, J. (1990). Full Catastrophe Living: How to Cope with Stress, Pain and Illness Using Mindfulness Meditation. New York, NY: Delacorte.

Reference Type: BACKGROUND

Other Identifiers

1-ZVG9

Identifier Type: -

Identifier Source: org_study_id