Dataset Information

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.

ABSTRACT: BACKGROUND:Caring for people with dementia (PWD) is stressful and poses many life challenges for the family caregivers. Interventions targeting the stress and psychological well-being of the caregivers have been proposed but the sustainable effects and efficacies of these interventions vary considerably. Mindfulness-based cognitive therapy (MBCT) has been shown to be effective at reducing stress in several populations. However, limited research on the effects of MBCT in family caregivers of PWD has been conducted. This study protocol aims to examine the effects on stress reduction of a modified MBCT for family caregivers of PWD. METHODS:A prospective, single-blind, parallel-group, randomized controlled trial will be adopted. A convenience sample of 100 community-dwelling family caregivers of PWD will be randomized to either the modified MBCT or the control groups. The modified MBCT group will receive a 10-week, seven-session, group-based modified MBCT whereas the control group will receive a social interaction and routine education (SIRE) on dementia care program at a frequency and timing similar to those in the intervention group. The primary outcomes (stress) and secondary outcomes (depression, anxiety, burden, health-related quality of life, and the behavioral and psychological symptoms of the care recipient) will be measured immediately post-intervention (T1) and at 6-month follow-up (T2), which will be compared with the baseline (T0). DISCUSSION:Reducing the stress of caregiving can promote the well-being of the family caregivers and maintain their sustainability in providing daily care for their family members with dementia. MBCT is found to be effective for stress reduction in other populations, and the results of this study are able to provide us with evidence for using MBCT as a standard supportive intervention for the family caregivers of PWD. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03354819 . Registered on 28 November 2017.

SUBMITTER: Kor PPK

PROVIDER: S-EPMC6542010 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Kor Patrick Pui Kin PPK Liu Justina Yat-Wa JY Chien Wai Tong WT

Trials 20190529 1

<h4>Background</h4>Caring for people with dementia (PWD) is stressful and poses many life challenges for the family caregivers. Interventions targeting the stress and psychological well-being of the caregivers have been proposed but the sustainable effects and efficacies of these interventions vary considerably. Mindfulness-based cognitive therapy (MBCT) has been shown to be effective at reducing stress in several populations. However, limited research on the effects of MBCT in family caregivers ...[more]

PMID: 31142366

Similar Datasets

Project description:Pre-symptomatic frontotemporal dementia (FTD) mutation carriers and first-degree family members that are 50% at-risk for FTD may experience symptoms of anxiety and depression as a result of the ambiguity of when or if symptoms of the disease will manifest. We conducted a pilot study to investigate the use of an online mindfulness-based stress reduction (MBSR) course to reduce symptoms of anxiety and depression in presymptomatic frontotemporal dementia (FTD) mutation carriers and individuals 50% at-risk. Seven known mutation carriers and six individuals 50% at-risk completed a standardized 8-week MBSR course, and filled out pre- and post and two-month follow-up questionnaires. The primary outcome measure was the Hospital Anxiety and Depression Scale (HADS). Measures of psychological distress (SCL-90-R), coping style (UCL), quality of life (SF-36) and mindfulness skills (FFMQ) were administered as secondary outcome. Group effects were analyzed with repeated measures ANOVA or Friedman's test, and the individual reliability change index (RCI) was calculated per participant for each outcome measure. Semi-quantitative data included an evaluation and process measure post-intervention. Significant decline was found on the HADS-A post-intervention and after 2 months (p = 0.01), with 54% and 62% of participants demonstrating a clinically significant RCI, respectively. On the HADS-D, significant decline was found 2 months post-intervention (p = 0.04), which was driven by 23% of participants whom had a clinically significant RCI. Additional changes were found between baseline and post-intervention on the seeking distraction and reassuring thoughts subscales of the UCL, the depression and interpersonal sensitivity subscales of the SCL, the observe subscale of the FFMQ, and on physical role limitations of the SF-36 (all p < 0.05). The process evaluation form indicated that the course was found beneficial by participants, and that they applied it in a wide range of everyday situations. This exploratory pilot study indicates the feasibility of MBSR in reducing anxiety and depression in presymptomatic FTD mutation carriers and 50% at-risk individuals. A randomized controlled trial is necessary to replicate these results.

Project description:BackgroundNonpharmacologic mind-body therapies have demonstrated efficacy in low back pain. However, the mechanisms underlying these therapies remain to be fully elucidated.ObjectiveIn response to these knowledge gaps, the Stanford Center for Low Back Pain-a collaborative, National Institutes of Health P01-funded, multidisciplinary research center-was established to investigate the common and distinct biobehavioral mechanisms of three mind-body therapies for chronic low back pain: cognitive behavioral therapy (CBT) that is used to treat pain, mindfulness-based stress reduction (MBSR), and electroacupuncture. Here, we describe the design and implementation of the center structure and the associated randomized controlled trials for characterizing the mechanisms of chronic low back pain treatments.MethodsThe multidisciplinary center is running two randomized controlled trials that share common resources for recruitment, enrollment, study execution, and data acquisition. We expect to recruit over 300 chronic low back pain participants across two projects and across different treatment arms within each project. The first project will examine pain-CBT compared with MBSR and a wait-list control group. The second project will examine real versus sham electroacupuncture. We will use behavioral, psychophysical, physical measure, and neuroimaging techniques to characterize the central pain modulatory and emotion regulatory systems in chronic low back pain at baseline and longitudinally. We will characterize how these interventions impact these systems, characterize the longitudinal treatment effects, and identify predictors of treatment efficacy.ResultsParticipant recruitment began on March 17, 2015, and will end in March 2023. Recruitment was halted in March 2020 due to COVID-19 and resumed in December 2021.ConclusionsThis center uses a comprehensive approach to study chronic low back pain. Findings are expected to significantly advance our understanding in (1) the baseline and longitudinal mechanisms of chronic low back pain, (2) the common and distinctive mechanisms of three mind-body therapies, and (3) predictors of treatment response, thereby informing future delivery of nonpharmacologic chronic low back pain treatments.Trial registrationClinicalTrials.gov NCT02503475; https://clinicaltrials.gov/ct2/show/NCT02503475.International registered report identifier (irrid)PRR1-10.2196/37823.

Project description:IntroductionCommunity-dwelling older adults living with subjective cognitive decline or mild cognitive impairment may experience decreased efficiency in their overall functional performance. This decreased cognitive efficiency may result in anxiety, low mood, perceived stress and decreased emotional well-being and quality-of-life. These psychological symptoms may further exacerbate cognitive decline.Exploring non-pharmacological interventions such as mindfulness within primary care is vital in enabling individuals to develop strategies to manage cognitive impairment or psychological symptoms. Mindfulness-based stress reduction (MBSR) is an 8-week programme that is beneficial in alleviating psychological symptoms; however, its impact on perceived satisfaction on overall functional performance with this population has not been evaluated. The primary objective of this study is to explore the feasibility of conducting a randomised controlled trial of an occupational therapist-led MBSR programme within primary care.MethodsConvergent mixed-methods, randomised control feasibility trial with 40 participants from an interprofessional primary care team in Toronto, Ontario. Participants are randomised into the 8-week MBSR group or wait-list control will be compared at baseline, postintervention and 4weeks follow-up. The primary aim is to determine the feasibility of the intervention with this population and setting. The secondary aim is to examine perceived satisfaction with functional performance as measured by the Canadian Occupational Performance Measure. Secondary clinical outcomes include psychological symptoms.AnalysisInvestigators will analyse the quantitative and qualitative data strands separately. Descriptive statistics, focus group and interviews will then be merged and further analysed to best understand the feasibility and preliminary clinical outcomes from the study.Ethics and disseminationThe study is approved by Women's College Hospital (2017-0056-E), and Queen's University, Kingston, Ontario (6026418). The study will follow Standard Protocol Items: Recommendations for Interventional Trials. The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.Trial registration numberNCT03867474; Pre-results.

Project description:BackgroundFamily caregivers of frail older adults experience high levels of stress. Mind-body interventions (MBIs) focused on caregiver stress are often limited in teaching approaches, difficult to practice, and costly. A social media-based MBI embedded with mindfulness meditation (MM) and self-administered acupressure (SA) may be effective for family caregivers, offer greater usability, and lead to greater adherence.ObjectiveThe aim of this study was to test the feasibility and preliminary effects of a social media-based MBI embedded with MM and SA on family caregivers of frail older adults and to investigate the preliminary effects of the intervention using a pilot randomized controlled trial.MethodsA 2-arm randomized controlled trial design was adopted. Family caregivers of frail older adults (n=64) were randomized into either the intervention group (n=32), receiving 8 weeks of social media-based MM and SA, or the control group (n=32), receiving brief education on caregiving for people with frailty. The primary outcome (caregiver stress) and secondary outcomes (caregiver burden, sleep quality, and mindfulness awareness and attention) were measured using a web-based survey at baseline (T0), immediately after the intervention (T1), and at the 3-month follow-up (T2).ResultsThe feasibility of the intervention was established with a high attendance rate (87.5%), high usability score (79), and low attrition rate (1.6%). The generalized estimating equation results showed that participants in the intervention group at T1 and T2 experienced a significant improvement in stress reduction (P=.02 and P=.04, respectively), sleep quality (P=.004 and P=.01, respectively), and mindful awareness and attention (P=.006 and P=.02, respectively) compared with the control group. There were no substantial improvements in caregiver burden at T1 and T2 (P=.59 and P=.47, respectively). A focus group session conducted after the intervention had 5 themes: impact on the family caregivers, difficulty in practicing the intervention, the strength of the program, the limitations of the program, and perception of the intervention.ConclusionsThe findings support the feasibility and preliminary effects of social media-based MBI embedded with acupressure and MM on reducing stress among family caregivers of frail older people and enhancing sleep quality and mindfulness levels. A future study with a larger and more diverse sample is proposed to evaluate the longer-term effects and generalizability of the intervention.Trial registrationChinese Clinical Trial Registry ChiCTR2100049507; http://www.chictr.org.cn/showproj.aspx?proj=128031.

Project description:OBJECTIVES:To assess the feasibility and acceptability of a mindfulness-based stress reduction (MBSR)-based intervention and determine if the intervention is associated with a significant signal on empathy and emotional competencies. DESIGN:Two pre-post proof-of-concept studies. SETTING:Participants were recruited at the University of Montreal's Psychology Department (Study 1) and the CHU Sainte-Justine Department of Hematology-Oncology (Study 2). PARTICIPANTS:Study 1: 12 students completed the 8-week programme (mean age 24, range 18-34). Study 2: 25 professionals completed the 8-week programme (mean age 48, range 27-63). INTERVENTION:Standard MBSR programme including 8-week mindfulness programme consisting of 8 consecutive weekly 2-hour sessions and a full-day silent retreat. OUTCOMES MEASURES:Mindfulness as measured by the Mindful Attention Awareness Scale; empathy as measured by the Interpersonal Reactivity Index (IRI)'s Perspective Taking and Empathic Concern subscales; identification of one's own emotions and those of others as measured by the Profile of Emotional Competence (PEC)'s Identify my Emotions and Identify Others' Emotions subscales; emotional acceptance as measured by the Acceptance and Action Questionnaire-II (AAQ-II) and the Emotion Regulation Scale (ERQ)'s Expressive Suppression subscale; and recognition of emotions in others as measured by the Geneva Emotion Recognition Test (GERT). RESULTS:In both studies, retention rates (80%-81%) were acceptable. Participants who completed the programme improved on all measures except the PEC's Identify Others' Emotions and the IRI's Empathic Concern (Cohen's d median=0.92, range 45-1.72). In Study 2, favourable effects associated with the programme were maintained over 3 months on the PEC's Identify my Emotions, the AAQ-II, the ERQ's Expressive Suppression and the GERT. CONCLUSIONS:The programme was feasible and acceptable. It was associated with a significant signal on the following outcomes: perspective taking, the identification of one's own emotions and emotional acceptance, thus, justifying moving towards efficacy trials using these outcomes.

Dataset Information

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.

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets