Effects of a Modified Mindfulness-based Cognitive Therapy for Family Caregivers of People With Dementia
NCT ID: NCT03354819
Last Updated: 2019-08-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
113 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-12-23
Study Completion Date
2019-06-23
Brief Summary
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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.
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Detailed Description
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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.
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
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Carer Stress Syndrome
Dementia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Outcome Assessors
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.
Study Groups
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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.
Group Type
EXPERIMENTAL
Modified MBCT
Intervention Type
BEHAVIORAL
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 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.
Group Type
ACTIVE_COMPARATOR
SIRE on dementia
Intervention Type
BEHAVIORAL
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
Interventions
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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
Intervention Type
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
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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).
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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The Hong Kong Polytechnic University
OTHER
Sponsor Role
lead
Responsible Party
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Patrick KOR Pui Kin
PhD candidate, Center for Gerontological Nursing, School of Nursing
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Justina Liu, PhD
Role: STUDY_CHAIR
The Hong Kong Polytechnic Univeristy
Locations
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Patrick Kor
Hong Kong, , Hong Kong
Site Status
Countries
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Hong Kong
References
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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.
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DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HSEARS20170929002
Identifier Type: -
Identifier Source: org_study_id
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