NCT03354819

Brief Summary

Caring for people with dementia (PWD) poses many challenges which may cause high levels of caregiver stress. This study aims to investigate the effects of a modified Mindfulness-based Cognitive Therapy for stress reduction in the family caregivers of PWD. A prospective, single-blind, parallel-group randomized controlled trial (RCT) of 76 family caregivers of PWD will be recruited and randomized to either the MBCT or the control groups.The primary outcomes (stress) and secondary outcomes (anxiety, depression, burden, quality of life and resilience) will be measured at immediate post-intervention (T1) and at 3 months follow up (T2) which will be compared with the baseline (T0). Mixed repeated measure MANOVA will be performed to assess the effects of time, group, and time-group interaction on all outcome measurements.To understand the therapeutic components and identify the strengths, limitations, and difficulties of the MBCT program, process evaluation will be conducted through focus group interviews with 15 participants from the MBI group. It is hypothesized that the MBCT group will have a significantly greater reduction of stress (primary outcome) and improvement in the secondary outcomes, namely depression, anxiety, and burden, at T1 and/or T2 than the control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

December 23, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

November 17, 2017

Last Update Submit

August 6, 2019

Conditions

Carer Stress SyndromeDementia

Outcome Measures

Primary Outcomes (1)

  • Change of Perceived Stress Scale (PSS)

    Perceived Stress Scale contains 10 items with 5-point Likert-type scale rating from 0 (never) to 4 (very often). The total score can range from 0 to 40 with higher scores indicating higher perceived stress. Comparisons of changes of Perceived Stress Scale will be considered as follows: T0 - T1; T0 - T2; T1 - T2

    At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)

Secondary Outcomes (5)

  • Zarit Burden Scale (ZBI).

    At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)

  • Change of Center for Epidemiologic Studies Depression Scale (CESD)

    At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)

  • Change of Hospital Anxiety and Depression Scale (HADS)

    At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)

  • Change of Brief Resilience Scale (BRS)

    At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)

  • Change of 12-Item Short Form Health Survey

    At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)

Other Outcomes (3)

  • Change of Five Facets Mindfulness Questionnaire-Short Form

    At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)

  • Weekly mindfulness practice (hours)

    Weekly starting from baseline T0, to 3 months after the intervention (follow-up assessment, T2)

  • Adherence rate of intervention

    Weekly starting from baseline T0 to 10th week (immediately post- intervention, T1)

Study Arms (2)

Modified MBCT

EXPERIMENTAL

A group-based, 10-week, 7-session modified Mindfulness Based Cognitive Therapy (MBCT) will be adopted in the MBCT intervention group with a group size of 15-20. The program includes different mindfulness activities (such as mindful eating and mindful walking) and peer sharing.

Behavioral: Modified MBCT

SIRE on dementia

ACTIVE COMPARATOR

The frequency of the Social Interactions and Routine Education (SIRE) program is the same as that of modified MBCT which consists of seven sessions (weekly for the first four sessions and bi-weekly for the last three sessions) and each session will last about two hours for 10 weeks with group size 15-20.

Behavioral: SIRE on dementia

Interventions

Modified MBCTBEHAVIORAL

Compared with the original protocol of Mindfulness-based Cognitive Therapy (Segal et al., 2002), the modified MBCT protocol in this pilot study has the following changes: Outline: Session 1 Awareness and automatic pilot: Session 2 Living in our head Session 3 Gathering the scattered mind Session 4 Recognizing aversion \& allowing Session 5 Thoughts are not facts Session 6 Take care of myself Session 7 Maintaining and extending new learning

Modified MBCT
SIRE on dementiaBEHAVIORAL

The SIRE program includes routine education sessions on dementia care, caregiver skills training, and group sharing on caregiving tasks. Outline: 1. Overview of dementia 2. Pharmacological and non-pharmacological treatment of dementia 3. BPSD in dementia care 4. Person center care 5. Advance planning in people with dementia 6. Principle of mindfulness 7. Non-pharmacological intervention on stress reduction

SIRE on dementia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years or above;
  • the blood or by-marriage relatives (e.g. spouses, siblings, children, and grandchildren) of a person who has been clinically diagnosed with dementia, regardless of its types (as mentioned in the operational definitions section (p. 1) and these relatives are taking up the caring responsibilities ranging from physical aids to emotional supports, in the form of transportation, financial assistance, personal hygiene, and decision-making.;
  • providing most of the daily care and support for PWD (daily contact for at least four hours); and
  • able to speak Cantonese (for understanding about all teaching materials and instructions).

You may not qualify if:

  • are practicing or recently learned meditation, mindfulness activities, and/or relaxation training in the past 6 months;
  • are diagnosed with a mental disorder such as bipolar disorder, schizophrenia, dementia, or depression; and/or,
  • are taking anticonvulsants, or any kind of psychotropic drugs, and/or identified with a self-reported suicidal thought or drug abuse in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patrick Kor

Hong Kong, Hong Kong

Location

Related Publications (62)

  • Adelman RD, Tmanova LL, Delgado D, Dion S, Lachs MS. Caregiver burden: a clinical review. JAMA. 2014 Mar 12;311(10):1052-60. doi: 10.1001/jama.2014.304.

    PMID: 24618967BACKGROUND

  • 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 May;76(5):341-51. doi: 10.1016/j.jpsychores.2014.02.012. Epub 2014 Mar 11.

    PMID: 24745774BACKGROUND

  • 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 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.

    PMID: 18310597BACKGROUND

  • Barnhofer T, Crane C, Hargus E, Amarasinghe M, Winder R, Williams JM. Mindfulness-based cognitive therapy as a treatment for chronic depression: A preliminary study. Behav Res Ther. 2009 May;47(5):366-73. doi: 10.1016/j.brat.2009.01.019. Epub 2009 Feb 5.

    PMID: 19249017BACKGROUND

  • Bazzano, A., Wolfe, C., Zylowska, L., Wang, S., Schuster, E., Barrett, C., & Lehrer, D. (2015). Mindfulness based stress reduction (MBSR) for parents and caregivers of individuals with developmental disabilities: a community-based approach. Journal of Child and Family Studies, 24(2), 298-308. doi: 10.1007/s10826-013-9836-9

    BACKGROUND

  • Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.

    PMID: 15367063BACKGROUND

  • 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 Nov;20(11):1157-1166. doi: 10.1080/13607863.2015.1065790. Epub 2015 Jul 27.

    PMID: 26211415BACKGROUND

  • Cerejeira J, Lagarto L, Mukaetova-Ladinska EB. Behavioral and psychological symptoms of dementia. Front Neurol. 2012 May 7;3:73. doi: 10.3389/fneur.2012.00073. eCollection 2012.

    PMID: 22586419BACKGROUND

  • Ko KT, Yip PK, Liu SI, Huang CR. Chinese version of the Zarit caregiver Burden Interview: a validation study. Am J Geriatr Psychiatry. 2008 Jun;16(6):513-8. doi: 10.1097/JGP.0b013e318167ae5b.

    PMID: 18515696BACKGROUND

  • 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 Psychiatry. 2010 Dec;20(4):163-8.

    PMID: 22348924BACKGROUND

  • Chan YF, Leung DY, Fong DY, Leung CM, 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 Aug;19(6):865-73. doi: 10.1007/s11136-010-9645-1. Epub 2010 Apr 7.

    PMID: 20373037BACKGROUND

  • 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 Oct;33(10):1166-72. doi: 10.1016/j.nedt.2012.11.014. Epub 2012 Dec 20.

    PMID: 23260618BACKGROUND

  • Chien, W.T., Cheung, D.S.K., Lai, C.K.Y., Yip, A.L.K., Kor, P.P.K., Moyle, W., Chambers, S., Jones, C., & Davies, N. (2017). [Use of a mindfulness-based intervention for family carers of people with dementia in the community: a feasibility study] Unpublished raw data.

    BACKGROUND

  • Chien WT, Thompson DR. Effects of a mindfulness-based psychoeducation programme for Chinese patients with schizophrenia: 2-year follow-up. Br J Psychiatry. 2014 Jul;205(1):52-9. doi: 10.1192/bjp.bp.113.134635. Epub 2014 May 8.

    PMID: 24809397BACKGROUND

  • Chiesa A, Calati R, Serretti A. Does mindfulness training improve cognitive abilities? A systematic review of neuropsychological findings. Clin Psychol Rev. 2011 Apr;31(3):449-64. doi: 10.1016/j.cpr.2010.11.003. Epub 2010 Dec 1.

    PMID: 21183265BACKGROUND

  • Chin WY, Choi EP, Chan KT, Wong CK. 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 Aug 7;10(8):e0135131. doi: 10.1371/journal.pone.0135131. eCollection 2015.

    PMID: 26252739BACKGROUND

  • Christopher, M. S., Goerling, R. J., Rogers, B. S., Hunsinger, M., Baron, G., Bergman, A. L., & Zava, D. T. (2016). A pilot study evaluating the effectiveness of a mindfulness-based intervention on cortisol awakening response and health outcomes among law enforcement officers. Journal of Police and Criminal Psychology, 31(1), 15-28. doi:10.1007/s11896-015-9161-x

    BACKGROUND

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND

  • Epstein-Lubow, G., McBee, L., Darling, E., Armey, M., & Miller, I. W. (2011). A pilot investigation of mindfulness-based stress reduction for caregivers of frail elderly. Mindfulness, 2(2), 95-102. doi: 10.1007/s12671-011-0047-4.

    BACKGROUND

  • Etters L, Goodall D, Harrison BE. Caregiver burden among dementia patient caregivers: a review of the literature. J Am Acad Nurse Pract. 2008 Aug;20(8):423-8. doi: 10.1111/j.1745-7599.2008.00342.x.

    PMID: 18786017BACKGROUND

  • Fialho PP, Koenig AM, Santos MD, Barbosa MT, Caramelli P. Positive effects of a cognitive-behavioral intervention program for family caregivers of demented elderly. Arq Neuropsiquiatr. 2012 Oct;70(10):786-92. doi: 10.1590/s0004-282x2012001000007.

    PMID: 23060105BACKGROUND

  • Garland, E., Gaylord, S., & Fredrickson, B. (2011). Positive reappraisal mediates the stress-reductive effects of mindfulness: an upward spiral process. Mindfulness, 2(1), 59-67. doi:10.1007/s12671-011-0043-8

    BACKGROUND

  • Gecht J, Kessel R, Forkmann T, Gauggel S, Drueke B, Scherer A, Mainz V. A mediation model of mindfulness and decentering: sequential psychological constructs or one and the same? BMC Psychol. 2014 Jul 7;2(1):18. doi: 10.1186/2050-7283-2-18. eCollection 2014.

    PMID: 25815189BACKGROUND

  • 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 Aug;48(8):738-46. doi: 10.1016/j.brat.2010.04.006. Epub 2010 Apr 18.

    PMID: 20462570BACKGROUND

  • The Practice of Nursing Research: Appraisal, Synthesis, and Generation of Evidence - Seventh edition Grove Susan K The Practice of Nursing Research: Appraisal, Synthesis, and Generation of Evidence - Seventh edition 752pp Elsevier 9781455707362 1455707368 [Formula: see text]. Nurs Stand. 2013 Apr 3;27(31):30. doi: 10.7748/ns2013.04.27.31.30.b1488.

    PMID: 26981669BACKGROUND

  • Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.

    PMID: 23459093BACKGROUND

  • Holzel BK, Lazar SW, Gard T, Schuman-Olivier Z, Vago DR, Ott U. How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Perspect Psychol Sci. 2011 Nov;6(6):537-59. doi: 10.1177/1745691611419671.

    PMID: 26168376BACKGROUND

  • Hou, J. (2012) The effects of mindfulness-based stress reduction program on depressive symptoms reduction among family caregivers in Hong Kong (Doctoral dissertation) Retrieved from CUHK Electronic Theses & Dissertations Collection.

    BACKGROUND

  • Hou RJ, Wong SY, Yip BH, Hung AT, Lo HH, Chan PH, Lo CS, Kwok TC, Tang WK, Mak WW, Mercer SW, Ma SH. The effects of mindfulness-based stress reduction program on the mental health of family caregivers: a randomized controlled trial. Psychother Psychosom. 2014;83(1):45-53. doi: 10.1159/000353278. Epub 2013 Nov 19.

    PMID: 24281411BACKGROUND

  • 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 Jun;21(3):363-71. doi: 10.1177/1073191113485121. Epub 2013 Apr 16.

    PMID: 23596271BACKGROUND

  • Imel Z, Baldwin S, Bonus K, Maccoon D. Beyond the individual: group effects in mindfulness-based stress reduction. Psychother Res. 2008 Nov;18(6):735-42. doi: 10.1080/10503300802326038.

    PMID: 18815948BACKGROUND

  • Jaffray L, Bridgman H, Stephens M, Skinner T. Evaluating the effects of mindfulness-based interventions for informal palliative caregivers: A systematic literature review. Palliat Med. 2016 Feb;30(2):117-31. doi: 10.1177/0269216315600331. Epub 2015 Aug 17.

    PMID: 26281853BACKGROUND

  • Jimenez, S. S., Niles, B. L., & Park, C. L. (2010). A mindfulness model of affect regulation and depressive symptoms: Positive emotions, mood regulation expectancies, and self-acceptance as regulatory mechanisms. Personality and Individual Differences, 49(6), 645-650. doi:10.1016/j.paid.2010.05.041

    BACKGROUND

  • Kabat-Zinn, J. (1990). Full catastrophe living : using the wisdom of your body and mind to face stress, pain, and illness. New York:Delacorte Press.

    BACKGROUND

  • Kenny MA, Williams JM. Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. Behav Res Ther. 2007 Mar;45(3):617-25. doi: 10.1016/j.brat.2006.04.008. Epub 2006 Jun 23.

    PMID: 16797486BACKGROUND

  • Kor, P. P. K., Chien, W. T., Liu, J. Y. W., & Lai, C. K. Y. (2017) Mindfulness-based intervention for stress reduction of family caregivers of people with dementia: a systematic review and meta-analysis. Mindfulness. Advance online publication. doi: 10.1007/s12671-017-0751-9

    BACKGROUND

  • Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005 Mar;14(2):539-47. doi: 10.1007/s11136-004-0704-3.

    PMID: 15892443BACKGROUND

  • Lam ET, Lam CL, Fong DY, 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 Feb;19(1):200-8. doi: 10.1111/j.1365-2753.2011.01800.x. Epub 2011 Nov 29.

    PMID: 22128754BACKGROUND

  • Lazarus, R. S., & Folkman, S. (1984). Stress, appraisal, and coping. New York: Springer

    BACKGROUND

  • Lebois LA, Papies EK, Gopinath K, Cabanban R, Quigley KS, Krishnamurthy V, Barrett LF, Barsalou LW. A shift in perspective: Decentering through mindful attention to imagined stressful events. Neuropsychologia. 2015 Aug;75:505-24. doi: 10.1016/j.neuropsychologia.2015.05.030. Epub 2015 Jun 22.

    PMID: 26111487BACKGROUND

  • Leung DY, Lam TH, Chan SS. Three versions of Perceived Stress Scale: validation in a sample of Chinese cardiac patients who smoke. BMC Public Health. 2010 Aug 25;10:513. doi: 10.1186/1471-2458-10-513.

    PMID: 20735860BACKGROUND

  • Maayan N, Soares-Weiser K, Lee H. Respite care for people with dementia and their carers. Cochrane Database Syst Rev. 2014 Jan 16;2014(1):CD004396. doi: 10.1002/14651858.CD004396.pub3.

    PMID: 24435941BACKGROUND

  • Manicavasgar V, Parker G, Perich T. Mindfulness-based cognitive therapy vs cognitive behaviour therapy as a treatment for non-melancholic depression. J Affect Disord. 2011 Apr;130(1-2):138-44. doi: 10.1016/j.jad.2010.09.027. Epub 2010 Nov 20.

    PMID: 21093925BACKGROUND

  • McCown, D., Reibel, D., & Micozzi, M. S. (2017). Resources for teaching mindfulness: An international handbook. New York: Springer International Publishing.

    BACKGROUND

  • Meinert, C. L., & Tonascia, S. (1986). Clinical trials: design, conduct, and analysis. UK: Oxford University Press

    BACKGROUND

  • 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 Oct;16(10):1031-8. doi: 10.1089/acm.2009.0733. Epub 2010 Oct 7.

    PMID: 20929380BACKGROUND

  • Paller KA, Creery JD, Florczak SM, Weintraub S, Mesulam MM, Reber PJ, Kiragu J, Rooks J, Safron A, Morhardt D, O'Hara M, Gigler KL, Molony JM, Maslar M. Benefits of mindfulness training for patients with progressive cognitive decline and their caregivers. Am J Alzheimers Dis Other Demen. 2015 May;30(3):257-67. doi: 10.1177/1533317514545377. Epub 2014 Aug 25.

    PMID: 25154985BACKGROUND

  • Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1(3), 385-401. doi:10.1177/014662167700100306

    BACKGROUND

  • Safran, J., & Segal, Z. V. (1996). Interpersonal process in cognitive therapy. New York: Jason Aronson.

    BACKGROUND

  • Salzer S, Winkelbach C, Leweke F, Leibing E, Leichsenring F. Long-term effects of short-term psychodynamic psychotherapy and cognitive-behavioural therapy in generalized anxiety disorder: 12-month follow-up. Can J Psychiatry. 2011 Aug;56(8):503-8. doi: 10.1177/070674371105600809.

    PMID: 21878162BACKGROUND

  • Santorelli, S. F. (2014). Mindfulness-based stress reduction (MBSR): Standards of practice. Retrieved from http://www.umassmed.edu/PageFiles/63144/mbsr_standards_of_practice_2014.pdf

    BACKGROUND

  • Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, not choice. Lancet. 2002 Feb 9;359(9305):515-9. doi: 10.1016/S0140-6736(02)07683-3.

    PMID: 11853818BACKGROUND

  • Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

    PMID: 20332509BACKGROUND

  • Schulz R, Martire LM. Family caregiving of persons with dementia: prevalence, health effects, and support strategies. Am J Geriatr Psychiatry. 2004 May-Jun;12(3):240-9.

    PMID: 15126224BACKGROUND

  • 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 Press.

    BACKGROUND

  • Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

    PMID: 18696313BACKGROUND

  • Sorensen S, Pinquart M, Duberstein P. How effective are interventions with caregivers? An updated meta-analysis. Gerontologist. 2002 Jun;42(3):356-72. doi: 10.1093/geront/42.3.356.

    PMID: 12040138BACKGROUND

  • 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 Sep-Oct;62(5):613-22. doi: 10.1097/00006842-200009000-00004.

    PMID: 11020090BACKGROUND

  • 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. 2015 Feb;35:19-34. doi: 10.1016/j.cpr.2014.11.002. Epub 2014 Nov 8.

    PMID: 25462111BACKGROUND

  • Wang F, Feng TY, Yang S, Preter M, Zhou JN, Wang XP. Drug Therapy for Behavioral and Psychological Symptoms of Dementia. Curr Neuropharmacol. 2016;14(4):307-13. doi: 10.2174/1570159x14666151208114232.

    PMID: 26644152BACKGROUND

  • Kor PPK, Liu JYW, Chien WT. Effects of a Modified Mindfulness-Based Cognitive Therapy for Family Caregivers of People With Dementia: A Randomized Clinical Trial. Gerontologist. 2021 Aug 13;61(6):977-990. doi: 10.1093/geront/gnaa125.

    PMID: 32886746DERIVED

  • Kor PPK, Liu JY, Chien WT. 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. Trials. 2019 May 29;20(1):303. doi: 10.1186/s13063-019-3432-2.

    PMID: 31142366DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Justina Liu, PhD

    The Hong Kong Polytechnic Univeristy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The eligible participants will be randomized into the 2 groups (MBCT and SIRE), following the allocation concealment mechanism by an independent assistant. The research assistants who were blinded to the group assignment performed all of the outcome measurements and data entries. The procedure and treatment allocation will be blinded to the investigator and the interventionists until the baseline measurement is completed.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A prospective, single-blind, parallel-group randomized controlled trial (RCT) will be adopted to test the hypotheses and compare the immediate effects and its effects over a 3-month follow up between the MBCT program and an active control group (social interactions and routine education on dementia care) for the family caregivers of PWD in the community. The MBCT program consists of seven sessions, including different mindfulness activities (such as mindful eating and mindful walking) and peer sharing, while the parallel active control group will have the social interactions and routine education on dementia care, including seven education sessions on dementia care, caregiver skills training and group sharing, aiming to control/balance the social interaction effects that can also be found in the MBI group. The study will also follow the guideline recommended by the latest Consolidated Standards of Reporting Trials (Schulz et al., 2010) statements.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate, Center for Gerontological Nursing, School of Nursing

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 28, 2017

Study Start

December 23, 2017

Primary Completion

May 23, 2019

Study Completion

June 23, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

HK(1)