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

NCT02667782 | Completed DMC

• 1 other identifier: 1-ZVG9
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety; Depression; Dependency Burden; Stress, Psychological

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change of Perceived Stress Scale (PSS)

  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

  [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 Outcomes (3)

• 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).

• 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).

• 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).

Study Arms (2)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

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).

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Mindfulness-Based Cognitive Therapy

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Interventions

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 Stress Reduction

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.

Mindfulness-Based Cognitive Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• is the primary carer
• of an adult with a confirmed diagnosis of dementia.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Griffith University: collaborator

Study Sites (2)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Community care centres

Kowloon, Hong Kong

Location

Related Publications (8)

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

  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

  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.

  PMID: 6880820 BACKGROUND

• 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.

  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.

  PMID: 7203086 BACKGROUND

• 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.

  PMID: 16443717 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress, Psychological; Dementia

Interventions

Mindfulness-Based Stress Reduction; Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Wai Tong Chien, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

• Wendy Moyle, PhD

  Griffith University

  PRINCIPAL INVESTIGATOR

• Daphne Cheung, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 29, 2016
• Study Start: February 18, 2016
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)