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Trial record 14 of 27634 for:    Change | Recruiting, Not yet recruiting, Available Studies

Effects of a Modified Mindfulness-based Cognitive Therapy for Family Caregivers of People With Dementia

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ClinicalTrials.gov Identifier: NCT03354819
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Patrick KOR Pui Kin, The Hong Kong Polytechnic University

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.

Condition or disease Intervention/treatment Phase
Carer Stress Syndrome Dementia Behavioral: Modified MBCT Behavioral: SIRE on dementia Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Effects of a Modified Mindfulness-based Cognitive Therapy for Family Caregivers of People With Dementia in Stress Reduction: A Randomized Controlled Trial
Actual Study Start Date : December 23, 2017
Estimated Primary Completion Date : June 23, 2019
Estimated Study Completion Date : December 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Modified MBCT
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

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


Active Comparator: SIRE on dementia
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

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




Primary Outcome Measures :
  1. Change of Perceived Stress Scale (PSS) [ Time Frame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2) ]

    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



Secondary Outcome Measures :
  1. Zarit Burden Scale (ZBI). [ Time Frame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2) ]

    Zarit Burden Scale comprises of 22 items including factors most frequently mentioned by caregivers as problem areas such as carer's health, psychological well-being, and the relationships between the carer and the patient with dementia. The score can range from 0 to 88. A higher score indicates greater carer distress.

    Comparisons of changes of Zarit Burden Scale will be considered as follows:

    T0 - T1; T0 - T2; T1 - T2


  2. Change of Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2) ]

    Center for Epidemiologic Studies Depression Scale is a self-reported measure of depression containing 20 items. It measures the common symptoms of depression in term of depressed mood, feelings of guilt and worthlessness, and feelings of helplessness. The scores can range from 0 to 60 and higher CESDS scores indicate increasing levels of depression.

    Comparisons of changes of Center for Epidemiologic Studies Depression Scale will be considered as follows:

    T0 - T1; T0 - T2; T1 - T2


  3. Change of Hospital Anxiety and Depression Scale (HADS) [ Time Frame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2) ]

    The level of anxiety will be measured by the Hospital Anxiety and Depression Scale which is a 7-item self-report instrument including specific items that assess generalized anxiety including tension, worry, fear, panic, difficulties in relaxing, and restlessness. The scores range from 0 to 21 and higher scores indicate increasing levels of anxiety

    Comparisons of changes of Hospital Anxiety and Depression Scale will be considered as follows:

    T0 - T1; T0 - T2; T1 - T2


  4. Change of Brief Resilience Scale (BRS) [ Time Frame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2) ]

    The level of resilience (the ability to bounce back or recover from stress) will be measured by the Brief Resilience Scale, which is a 6-item, self-report and 5-point rating scale. The scores can range from 6 to 30 with higher scores indicating higher level of resilience.

    Comparisons of changes of Brief Resilience Scale will be considered as follows:

    T0 - T1; T0 - T2; T1 - T2


  5. Change of 12-Item Short Form Health Survey [ Time Frame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2) ]

    Caregivers' health-related quality of life will be measured by 12-Item Short Form Health Survey. It contains twelve questions and ranges from 0 to 100, where a zero score indicates the lowest level of healthmeasured by the scales and 100 indicates the highest level of health

    Comparisons of changes of 12-Item Short Form Health Survey will be considered as follows:

    T0 - T1; T0 - T2; T1 - T2



Other Outcome Measures:
  1. Change of Five Facets Mindfulness Questionnaire-Short Form [ Time Frame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2) ]

    Caregivers' level of mindfulness will be measured as the process indicator by using the Five Facets Mindfulness Questionnaire Short Form. It is a self-report questionnaire measuring the five facets of mindfulness which includes observing, describing, acting with awareness, non-judging of inner and non-reactivity to inner experience (e.g., "I'm good at finding words to describe my feelings"). The total score ranges from 20 to 100 and the higher the score, the higher level of mindfulness.

    Comparisons of changes of Five Facets Mindfulness Questionnaire-Short Form will be considered as follows:

    T0 - T1; T0 - T2; T1 - T2


  2. Weekly mindfulness practice (hours) [ Time Frame: Weekly starting from baseline T0, to 3 months after the intervention (follow-up assessment, T2) ]
    Weekly mindfulness practice will be measured by the average number of hours in practicing mindfulness per week from T0 to T2.

  3. Adherence rate of intervention [ Time Frame: Weekly starting from baseline T0 to 10th week (immediately post- intervention, T1) ]
    The (Number of sessions a participant is present) / (Total number of intervention sessions) will be measured to indicate the adherence rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. aged 18 years or above;
  2. 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.;
  3. providing most of the daily care and support for PWD (daily contact for at least four hours); and
  4. able to speak Cantonese (for understanding about all teaching materials and instructions).

Exclusion Criteria:

  1. are practicing or recently learned meditation, mindfulness activities, and/or relaxation training in the past 6 months;
  2. are diagnosed with a mental disorder such as bipolar disorder, schizophrenia, dementia, or depression; and/or,
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354819


Contacts
Contact: Patrick PK KOR, MSc 852-64451617 patrick.kor@polyu.edu.hk
Contact: Wai-Tong Chien, PhD 852-27665648 wai.tong.chien@polyu.edu.hk

Locations
Hong Kong
Patrick Kor Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Study Chair: Justina Liu, PhD The Hong Kong Polytechnic Univeristy

Publications:
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
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.
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
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.
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
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.
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
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.
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
Lazarus, R. S., & Folkman, S. (1984). Stress, appraisal, and coping. New York: Springer
McCown, D., Reibel, D., & Micozzi, M. S. (2017). Resources for teaching mindfulness: An international handbook. New York: Springer International Publishing.
Meinert, C. L., & Tonascia, S. (1986). Clinical trials: design, conduct, and analysis. UK: Oxford University Press
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
Safran, J., & Segal, Z. V. (1996). Interpersonal process in cognitive therapy. New York: Jason Aronson.
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
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.

Responsible Party: Patrick KOR Pui Kin, PhD candidate, Center for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03354819     History of Changes
Other Study ID Numbers: HSEARS20170929002
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders