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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667782
• Other study ID #: 1-ZVG9
• Status: Completed
• Phase: N/A
• First received: January 21, 2016
• Last updated: February 20, 2018
• Start date: February 18, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: February 2018
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Dementia
• Dependency Burden
• Depression
• Stress, Psychological

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The Hong Kong Polytechnic University	Hong Kong
Hong Kong	Community care centres	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Griffith University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (8)

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. — View 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

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

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

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.

Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).