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Published in: Trials 1/2019

Open Access 01-12-2019 | Affective Disorder | Study protocol

Effects on stress reduction of a modified mindfulness-based cognitive therapy for family caregivers of those with dementia: study protocol for a randomized controlled trial

Authors: Patrick Pui Kin Kor, Justina Yat-Wa Liu, Wai Tong Chien

Published in: Trials | Issue 1/2019

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Abstract

Background

Caring for people with dementia (PWD) is stressful and poses many life challenges for the family caregivers. Interventions targeting the stress and psychological well-being of the caregivers have been proposed but the sustainable effects and efficacies of these interventions vary considerably. Mindfulness-based cognitive therapy (MBCT) has been shown to be effective at reducing stress in several populations. However, limited research on the effects of MBCT in family caregivers of PWD has been conducted. This study protocol aims to examine the effects on stress reduction of a modified MBCT for family caregivers of PWD.

Methods

A prospective, single-blind, parallel-group, randomized controlled trial will be adopted. A convenience sample of 100 community-dwelling family caregivers of PWD will be randomized to either the modified MBCT or the control groups. The modified MBCT group will receive a 10-week, seven-session, group-based modified MBCT whereas the control group will receive a social interaction and routine education (SIRE) on dementia care program at a frequency and timing similar to those in the intervention group. The primary outcomes (stress) and secondary outcomes (depression, anxiety, burden, health-related quality of life, and the behavioral and psychological symptoms of the care recipient) will be measured immediately post-intervention (T1) and at 6-month follow-up (T2), which will be compared with the baseline (T0).

Discussion

Reducing the stress of caregiving can promote the well-being of the family caregivers and maintain their sustainability in providing daily care for their family members with dementia. MBCT is found to be effective for stress reduction in other populations, and the results of this study are able to provide us with evidence for using MBCT as a standard supportive intervention for the family caregivers of PWD.

Trial registration

ClinicalTrials.gov, NCT03354819. Registered on 28 November 2017.
Appendix
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Literature
1.
Chan WC, Ng C, Mok CC, Wong FL, Pang SL, Chiu HF. Lived experience of caregivers of persons with dementia in Hong Kong: a qualitative study. East Asian Arch Psychiatr. 2010;20(4):163–8.
2.
Adelman RD, Tmanova LL, Delgado D, Dion S, Lachs MS. Caregiver burden: a clinical review. JAMA. 2014;311(10):1052–60.CrossRef
3.
Maayan N, Soares-Weiser K, Lee H. Respite care for people with dementia and their carers. Cochrane Database Syst Rev. 2014;16(1):CD004396.
4.
Sörensen S, Pinquart M, Duberstein P. How effective are interventions with caregivers? An updated meta-analysis. Gerontologist. 2002;42(3):356–72.CrossRef
5.
Lazarus RS, Folkman S. Stress, appraisal, and coping. New York: Springer; 1984.
6.
Iavarone A, Ziello AR, Pastore F, Fasanaro AM, Poderico C. Caregiver burden and coping strategies in caregivers of patients with Alzheimer’s disease. Neuropsychiatr Dis Treat. 2014;10:1407–13.PubMedPubMedCentral
7.
Stratford HJ, Cooper MJ, Di Simplicio M, Blackwell SE, Holmes EA. Psychological therapy for anxiety in bipolar spectrum disorders: a systematic review. Clin Psychol Rev. 2014;35c:19–34.
8.
Chien WT, Thompson DR. Effects of a mindfulness-based psychoeducation programme for Chinese patients with schizophrenia: 2-year follow-up. Br J Psychiatry. 2014;205(1):52–9.CrossRef
9.
Chiesa A, Calati R, Serretti A. Does mindfulness training improve cognitive abilities? A systematic review of neuropsychological findings. Clin Psychol Rev. 2011;31(3):449–64.CrossRef
10.
Paller KA, Creery JD, Florczak SM, Weintraub S, Mesulam M-M, Reber PJ, Kiragu J, Rooks J, Safron A, Morhardt D, et al. Benefits of mindfulness training for patients with progressive cognitive decline and their caregivers. Am J Alzheimers Dis Other Dement. 2015;30(3):257–67.CrossRef
11.
Chen Y, Yang X, Wang L, Zhang X. A randomized controlled trial of the effects of brief mindfulness meditation on anxiety symptoms and systolic blood pressure in Chinese nursing students. Nurse Educ Today. 2013;33(10):1166–72.CrossRef
12.
Jimenez SS, Niles BL, Park CL. A mindfulness model of affect regulation and depressive symptoms: positive emotions, mood regulation expectancies, and self-acceptance as regulatory mechanisms. Personal Individ Differ. 2010;49(6):645–50.CrossRef
13.
Kabat-Zinn J. Full catastrophe living: using the wisdom of your body and mind to face stress, pain, and illness. New York: Delacorte Press; 1990.
14.
Segal ZV, Williams JMG, Teasdale JD. Mindfulness-based cognitive therapy for depression : a new approach to preventing relapse. New York: Guilford Press; 2002.
15.
Kor PPK, Chien WT, Liu JYW, Lai CKY. Mindfulness-based intervention for stress reduction of family caregivers of people with dementia: a systematic review and meta-analysis. Mindfulness. 2018;9(1):7–22.CrossRef
16.
Cheung DSK, Lai CKY, Kor P, Chien W-T, King Yip AL, Yu C, Chambers S, Jones C, Davies N, Moyle W. Mindfulness-based intervention for family carers of people with dementia in the community: preliminary results from a feasibility study. Alzheimers Dement. 2017;13(7):P837.CrossRef
17.
Speca M, Carlson LE, Goodey E, Angen M. A randomized, wait-list controlled clinical trial: the effect of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients. Psychosom Med. 2000;62(5):613–22.CrossRef
18.
Etters L, Goodall D, Harrison BE. Caregiver burden among dementia patient caregivers: a review of the literature. J Am Assoc Nurse Pract. 2008;20(8):423–8.CrossRef
19.
Bazzano A, Wolfe C, Zylowska L, Wang S, Schuster E, Barrett C, Lehrer D. Mindfulness based stress reduction (MBSR) for parents and caregivers of individuals with developmental disabilities: a community-based approach. J Child Fam Stud. 2015;24(2):298–308.CrossRef
20.
Brown KW, Coogle CL, Wegelin J. A pilot randomized controlled trial of mindfulness-based stress reduction for caregivers of family members with dementia. Aging Ment Health. 2016;20(11):1157–66.CrossRef
21.
Imel Z, Baldwin S, Bonus K, MacCoon D. Beyond the individual: group effects in mindfulness-based stress reduction. Psychother Res. 2008;18(6):735–42.CrossRef
22.
Barnhofer T, Crane C, Hargus E, Amarasinghe M, Winder R, Williams JMG. Mindfulness-based cognitive therapy as a treatment for chronic depression: a preliminary study. Behav Res Ther. 2009;47(5):366–73.CrossRef
23.
Godfrin KA, van Heeringen C. The effects of mindfulness-based cognitive therapy on recurrence of depressive episodes, mental health and quality of life: a randomized controlled study. Behav Res Ther. 2010;48(8):738–46.CrossRef
24.
Kenny MA, Williams JMG. Treatment-resistant depressed patients show a good response to mindfulness-based cognitive therapy. Behav Res Ther. 2007;45(3):617–25.CrossRef
25.
Epstein-Lubow G, McBee L, Darling E, Armey M, Miller IW. A pilot investigation of mindfulness-based stress reduction for caregivers of frail elderly. Mindfulness. 2011;2(2):95–102.CrossRef
26.
Oken BS, Fonareva I, Haas M, Wahbeh H, Lane JB, Zajdel D, Amen A. Pilot controlled trial of mindfulness meditation and education for dementia caregivers. J Altern Complement Med. 2010;16(10):1031–8.CrossRef
27.
Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004;23(5):443–51.CrossRef
28.
McCown D, Reibel D, Micozzi MS. Resources for teaching mindfulness: an international handbook. Cham: Springer International Publishing; 2017.
29.
Christopher MS, Goerling RJ, Rogers BS, Hunsinger M, Baron G, Bergman AL, Zava DT. A pilot study evaluating the effectiveness of a mindfulness-based intervention on cortisol awakening response and health outcomes among law enforcement officers. J Police Crim Psychol. 2016;31(1):15–28.CrossRef
30.
Leung DY, Lam T-h, Chan SS. Three versions of Perceived Stress Scale: validation in a sample of Chinese cardiac patients who smoke. BMC Public Health. 2010;10(1):513.CrossRef
31.
Cohen S, Tom K, Robin M. A Global measure of perceived stress. J Health Soc Behav. 1983;24(4):385–96.CrossRef
32.
Chu LC, Kao HS. The moderation of meditation experience and emotional intelligence on the relationship between perceived stress and negative mental health. Chin J Psychol. 2005;47(2):157–79.
33.
Abbott RA, Whear R, Rodgers LR, Bethel A, Thompson Coon J, Kuyken W, Stein K, Dickens C. Effectiveness of mindfulness-based stress reduction and mindfulness based cognitive therapy in vascular disease: a systematic review and meta-analysis of randomised controlled trials. J Psychosom Res. 2014;76(5):341–51.CrossRef
34.
Chan T, Lam L, Chiu H. Validation of Chinese version of the Zarit Burden Interview. Hong Kong J Psychiatry. 2005;15(1):9–13.
35.
Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980;20(6):649–55.CrossRef
36.
Chin WY, Choi EPH, Chan KTY, Wong CKH. The psychometric properties of the Center for Epidemiologic Studies Depression Scale in Chinese primary care patients: factor structure, construct validity, reliability, sensitivity and responsiveness. PLoS One. 2015;10(8):e0135131.CrossRef
37.
Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas. 1977;1(3):385–401.CrossRef
38.
Wang W, Chair SY, Thompson DR, Twinn SF. A psychometric evaluation of the Chinese version of the Hospital Anxiety and Depression Scale in patients with coronary heart disease. J Clin Nurs. 2009;18(13):1908–15.CrossRef
39.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.CrossRef
40.
Chan Y-F, Leung DYP, Fong DYT, Leung C-M, Lee AM. Psychometric evaluation of the Hospital Anxiety and Depression Scale in a large community sample of adolescents in Hong Kong. Qual Life Res. 2010;19(6):865–73.CrossRef
41.
Lai JCL, Yue X. Using the Brief Resilience Scale to assess Chinese people’s ability to bounce back from stress. SAGE Open. 2014;4(4):2158244014554386.CrossRef
42.
Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. J Behav Med. 2008;15(3):194–200.CrossRef
43.
Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005;14(2):539–47.CrossRef
44.
Lam ETP, Lam CLK, Fong DYT, Huang WW. Is the SF-12 version 2 Health Survey a valid and equivalent substitute for the SF-36 version 2 Health Survey for the Chinese? J Eval Clin Pract. 2013;19(1):200–8.CrossRef
45.
Wong A, Cheng S-T, Lo ESK, Kwan PWL, Law LSN, Chan AYY, Wong LK-S, Mok V. Validity and reliability of the Neuropsychiatric Inventory Questionnaire version in patients with stroke or transient ischemic attack having cognitive impairment. J Geriatr Psychiatry Neurol. 2014;27(4):247–52.CrossRef
46.
Hou J, Wong SY, Lo HH, Mak WW, Ma HS. Validation of a Chinese version of the Five Facet Mindfulness Questionnaire in Hong Kong and development of a short form. Assessment. 2014;21(3):363–71.CrossRef
47.
Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008;15(3):329–42.CrossRef
48.
Gupta SK. Intention-to-treat concept: a review. Perspect Clin Res. 2011;2(3):109–12.CrossRef
49.
Schroeder MA, Lander J, Levine-Silverman S. Diagnosing and dealing with multicollinearity. West J Nurs Res. 1990;12(2):175–87.CrossRef
50.
Hamer RM, Simpson PM. Last observation carried forward versus mixed models in the analysis of psychiatric clinical trials. Am J Psychiatry. 2009;166(6):639–41.CrossRef
51.
Gray JR, Grove SK, Burns N. The practice of nursing research—E-book: appraisal, synthesis, and generation of evidence. St. Louis: Elsevier Health Sciences; 2013.
52.
Sterne JAC, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009;338:b2393.CrossRef
53.
Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013;9(1):63–75.CrossRef
54.
Clare L, Wilson BA, Carter G, Breen K, Berrios GE, Hodges JR. Depression and anxiety in memory clinic attenders and their carers: implications for evaluating the effectiveness of cognitive rehabilitation interventions. Int J Geriatr Psychiatry. 2002;17(10):962–7.CrossRef
55.
Cooper C, Balamurali TB, Selwood A, Livingston G. A systematic review of intervention studies about anxiety in caregivers of people with dementia. Int J Geriatr Psychiatry. 2007;22(3):181–8.CrossRef
56.
Feast A, Moniz-Cook E, Stoner C, Charlesworth G, Orrell M. A systematic review of the relationship between behavioral and psychological symptoms (BPSD) and caregiver well-being. Int Psychogeriatr. 2016;28(11):1761–74.CrossRef
Metadata
Title
Effects on stress reduction of a modified mindfulness-based cognitive therapy for family caregivers of those with dementia: study protocol for a randomized controlled trial
Authors
Patrick Pui Kin Kor
Justina Yat-Wa Liu
Wai Tong Chien
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3432-2

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