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

Not Applicable

Completed

• Conditions: Depression; Anxiety; Dependency Burden; Stress, Psychological
• Interventions: Behavioral: Mindfulness-Based Stress Reduction (MBSR); Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

• Registration Number: NCT02667782
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Study Timeline

• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Study Start: 2016-02-18
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Stress Reduction	Mindfulness-Based Stress Reduction (MBSR)	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	Mindfulness-Based Cognitive Therapy (MBCT)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (2)

Community care centres; 🇭🇰 Kowloon, Hong Kong

School of Nursing, The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong