Clinical trial NCT03354819: Effects of a Modified Mindfulness-based Cognitive Therapy for Family Caregivers of People With Dementia
Official title: Effects of a Modified Mindfulness-based Cognitive Therapy for Family Caregivers of People With Dementia in Stress Reduction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carer Stress Syndrome
Dementia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change of Perceived Stress Scale (PSS)
timeFrame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)
Secondary outcomes:
measure: Zarit Burden Scale (ZBI).
timeFrame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)
measure: Change of Center for Epidemiologic Studies Depression Scale (CESD)
timeFrame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)
measure: Change of Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)
measure: Change of Brief Resilience Scale (BRS)
timeFrame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)
measure: Change of 12-Item Short Form Health Survey
timeFrame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)
Other outcomes:
measure: Change of Five Facets Mindfulness Questionnaire-Short Form
timeFrame: At baseline (T0), 10th week (immediately post- intervention; T1), and 3 months after the intervention (follow-up assessment, T2)
measure: Weekly mindfulness practice (hours)
timeFrame: Weekly starting from baseline T0, to 3 months after the intervention (follow-up assessment, T2)
measure: Adherence rate of intervention
timeFrame: Weekly starting from baseline T0 to 10th week (immediately post- intervention, T1)
Locations:
city: Hong Kong
country: Hong Kong
facility: Patrick Kor
Study officials:
affiliation: The Hong Kong Polytechnic Univeristy
name: Justina Liu, PhD
role: STUDY_CHAIR
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