Carer Stress SyndromeNCT03354819
Effects of a Modified Mindfulness-based Cognitive Therapy for Family Caregivers of People With Dementia
A study testing Modified MBCT and SIRE on dementia in people with Carer Stress Syndrome and Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carer Stress Syndrome, Dementia
- What is being tested?
- Modified MBCT and SIRE on dementia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Dec 2017to 23 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Modified Mindfulness-based Cognitive Therapy for Family Caregivers of People With Dementia in Stress Reduction: A Randomized Controlled Trial
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.
Read the detailed description
Background:
Caring for people with dementia (PWD) poses many challenges which may cause high levels of caregiver stress. Mindfulness-based intervention (MBI) is a newly adopted psychosocial intervention through an integration of the mind and body to reduce stress of the participants. A systematic review was conducted with five studies (four RCTs and one quasi-experimental study) to investigate the effect of MBI in stress reduction in the family caregivers of PWD. Of these, three trials involving 144 participants were eligible for the meta-analysis. The result showed that the stress levels dropped significantly after an 8-week MBI in the family caregivers of PWD with a moderate aggregated effect size of 0.57 (95% CI [0.23, 0.92], overall effect Z= 3.25 at p= 0.001). While MBI's immediate effect was found, the long term effect was unclear. Besides a limited number of clinical trials and several limitations (such as poor study design and small sample size) were also identified in this review. It signifies that more studies are still required to examine the effects of MBI for family caregivers of PWD. Since MBI is a new intervention for stress management among the family caregivers of PWD, a feasibility study was conducted between 2016 and 2017. It found that the family caregivers could master the mindfulness skill after the mindfulness sessions with a low attrition rate of 3.8%. A modified Mindfulness-based cognitive therapy (MBCT) protocol was also validated in the study to fit the local need and address the limitations identified in previous studies.
Objective:
This study aims to investigate the effects of a modified MBCT for stress reduction in the family caregivers of PWD in Hong Kong.
Methods:
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 MBI groups will receive a seven-week, group-based MBCT training whereas the control group will receive social interactions and routine education on dementia care program of a frequency and timing similar to those of the MBI group. The primary outcomes (stress) and secondary outcomes (anxiety, depression, burden, quality of life, 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. Both per-protocol (PP) and intention-to-treat (ITT) analysis will be performed in order to find out more factors affecting the use and effectiveness of MBCT such as non-compliance and acceptability. 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 anxiety, depression, burden, quality of life, and resilience at T1 and/or T2 than the control group.
Significance and Value:
Reducing the caregiving stress level can promote the well-being of the family caregivers to maintain their sustainability in terms of providing daily care for their family members with dementia for a longer period of time. Evidence shows a minimal and short term effects of other psychosocial interventions (such as respite care, mutual support group) for reducing caregivers' stress. On the other hand, the MBCT is found effective in stress reduction in other populations. This finding is also supported by a feasibility study of using the MBI in family caregivers of PWD. The results of this study may be able to provide us with evidence for using MBCT as a standard supportive intervention for the family caregivers of PWD.
- Conditions
- Carer Stress Syndrome, Dementia
- Being tested
- Modified MBCT, SIRE on dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified MBCTBehavioural
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
SIRE on dementiaBehavioural
The SIRE program includes routine education sessions on dementia care, caregiver skills training, and group sharing on caregiving tasks.
Outline:
- Overview of dementia
- Pharmacological and non-pharmacological treatment of dementia
- BPSD in dementia care
- Person center care
- Advance planning in people with dementia
- Principle of mindfulness
- Non-pharmacological intervention on stress reduction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: SIRE on dementia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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
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
Measured: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start23 Dec 2017
- Primary completion23 May 2019
- Study completion23 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (62)Papers the sponsor has linked to this study.
- Other trials for Carer Stress SyndromeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick KOR Pui Kin, The Hong Kong Polytechnic University
- Investigators
- Justina Liu, PhD, Study chair, The Hong Kong Polytechnic Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354819
- Sponsor's protocol ID
- HSEARS20170929002
- Status last verified
- Aug 2019
- First submitted
- 17 Nov 2017
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24618967Abbott 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.
PubMed 24745774Baer 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.
PubMed 18310597Barnhofer 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.
PubMed 19249017Bazzano, 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
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.
PubMed 15367063Brown 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.
PubMed 26211415Cerejeira 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.
PubMed 22586419Ko 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.
PubMed 18515696Chan 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.
PubMed 22348924Chan 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.
PubMed 20373037Chen 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.
PubMed 23260618Chien, 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.
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.
PubMed 24809397Chiesa 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.
PubMed 21183265
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Modified Mindfulness-based Cognitive Therapy for Family Caregivers of People With Dementia in Stress Reduction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03354819
- Acronym / sponsor ID
- HSEARS20170929002
- Conditions
- Carer Stress Syndrome, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 23 Dec 2017 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 Jun 2019 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Caring for people with dementia (PWD) poses many challenges which may cause high levels of caregiver stress. Mindfulness-based intervention (MBI) is a newly adopted psychosocial intervention through an integration of the mind and body to reduce stress of the participants. A systematic review was conducted with five studies (four RCTs and one quasi-experimental study) to investigate the effect of MBI in stress reduction in the family caregivers of PWD. Of these, three trials involving 144 participants were eligible for the meta-analysis. The result showed that the stress levels dropped significantly after an 8-week MBI in the family caregivers of PWD with a moderate aggregated effect size of 0.57 (95% CI [0.23, 0.92], overall effect Z= 3.25 at p= 0.001). While MBI's immediate effect was found, the long term effect was unclear. Besides a limited number of clinical trials and several limitations (such as poor study design and small sample size) were also identified in this review. It signifies that more studies are still required to examine the effects of MBI for family caregivers of PWD. Since MBI is a new intervention for stress management among the family caregivers of PWD, a feasibility study was conducted between 2016 and 2017. It found that the family caregivers could master the mindfulness skill after the mindfulness sessions with a low attrition rate of 3.8%. A modified Mindfulness-based cognitive therapy (MBCT) protocol was also validated in the study to fit the local need and address the limitations identified in previous studies.
Objective:
This study aims to investigate the effects of a modified MBCT for stress reduction in the family caregivers of PWD in Hong Kong.
Methods:
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 MBI groups will receive a seven-week, group-based MBCT training whereas the control group will receive social interactions and routine education on dementia care program of a frequency and timing similar to those of the MBI group. The primary outcomes (stress) and secondary outcomes (anxiety, depression, burden, quality of life, 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. Both per-protocol (PP) and intention-to-treat (ITT) analysis will be performed in order to find out more factors affecting the use and effectiveness of MBCT such as non-compliance and acceptability. 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 anxiety, depression, burden, quality of life, and resilience at T1 and/or T2 than the control group.
Significance and Value:
Reducing the caregiving stress level can promote the well-being of the family caregivers to maintain their sustainability in terms of providing daily care for their family members with dementia for a longer period of time. Evidence shows a minimal and short term effects of other psychosocial interventions (such as respite care, mutual support group) for reducing caregivers' stress. On the other hand, the MBCT is found effective in stress reduction in other populations. This finding is also supported by a feasibility study of using the MBI in family caregivers of PWD. The results of this study may be able to provide us with evidence for using MBCT as a standard supportive intervention for the family caregivers of PWD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Modified MBCT | Experimental | Behavioral: Modified MBCTA 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. |
| SIRE on dementia | Active comparator | Behavioral: SIRE on dementiaThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified MBCTCompared 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 | Behavioural | Modified MBCT |
| SIRE on dementiaThe 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 | Behavioural | SIRE on dementia |
Primary outcome
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
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 24618967Adelman 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.
- Background: PubMed 24745774Abbott 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.
- Background: PubMed 18310597Baer 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.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justina Liu, PhD study chair
The Hong Kong Polytechnic Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified MBCT and SIRE on dementia in people with Carer Stress Syndrome and Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354819, which also lists 62 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.