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Brief Mindfulness Intervention vs. Health Enhancement Program for Patients Undergoing Dialysis: A Randomized Controlled Trial.

ABSTRACT: Between 20-50% of patients undergoing maintenance dialysis for end-stage kidney disease experience symptoms of depression and/or anxiety, associated with increased mortality, greater health care utilization, and decreased quality of life. It is unknown whether mindfulness-based interventions can improve depression and anxiety symptoms in patients receiving this treatment. We conducted an 8-week multicenter randomized controlled trial comparing a brief mindfulness intervention (BMI) vs. an active control (Health Enhancement Program [HEP]) in 55 patients receiving dialysis with symptoms of depression and/or anxiety. The primary outcome was change in Patient Health Questionnaire-9 (PHQ-9) depression scores, with a primary analysis in participants with baseline PHQ-9 ≥ 10, and a secondary analysis including all participants. The secondary outcome was change in Generalized Anxiety Disorder-7 (GAD-7) anxiety scores with corresponding primary and secondary analyses. Both BMI and HEP reduced depressive symptoms, with no difference between trial arms (PHQ-9 change = -7.0 vs. -6.1, p = 0.62). BMI was more effective than HEP in reducing anxiety (GAD-7 change = -8.7 vs. -1.4, p = 0.01). Secondary analyses revealed no differences between arms. For patients undergoing dialysis, both BMI and HEP may be helpful interventions for depression symptoms, and BMI may be superior to HEP for anxiety symptoms. Mindfulness-based and other psychosocial interventions may be further evaluated in those undergoing dialysis as treatment options for symptoms of depression and anxiety.

SUBMITTER: Nassim M

PROVIDER: S-EPMC8228217 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Brief Mindfulness Intervention vs. Health Enhancement Program for Patients Undergoing Dialysis: A Randomized Controlled Trial.

Nassim Marouane M Park Haley H Dikaios Elena E Potes Angela A Elbaz Sasha S Mc Veigh Clare C Lipman Mark M Novak Marta M Trinh Emilie E Alam Ahsan A Suri Rita S RS Thomas Zoe Z Torres-Platas Susana S Vasudev Akshya A Sasi Neeti N Gautier Maryse M Mucsi Istvan I Noble Helen H Rej Soham S

Healthcare (Basel, Switzerland) 20210601 6

<h4>Background</h4>Between 20-50% of patients undergoing maintenance dialysis for end-stage kidney disease experience symptoms of depression and/or anxiety, associated with increased mortality, greater health care utilization, and decreased quality of life. It is unknown whether mindfulness-based interventions can improve depression and anxiety symptoms in patients receiving this treatment.<h4>Methods</h4>We conducted an 8-week multicenter randomized controlled trial comparing a brief mindfulnes ...[more]

PMID: 34205915

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Project description:BackgroundDepression and anxiety affect approximately 50% of patients with kidney failure receiving hemodialysis and are associated with decreased quality of life and increased risk of hospitalization and mortality. A Brief Mindfulness Intervention (BMI) may be promising in treating depressive and anxiety symptoms in this population, but the long-term sustainability of the intervention's effects is unknown.ObjectiveWe previously conducted a randomized controlled trial (RCT; n = 55) comparing an 8-week BMI with an active control (Health Enhancement Program [HEP]) for patients receiving dialysis, with depression and/or anxiety. Here, we examine the 6-month follow-up data to determine the long-term sustainability of BMI versus HEP in reducing (1) depressive symptoms, (2) anxiety symptoms, and (3) the efficacy of BMI versus HEP in reducing the likelihood of hospitalization.DesignIn this study, we analyzed 6-month follow-up data from an 8-week assessor-blinded parallel RCT, which evaluated the efficacy of a BMI against an active control, HEP, in patients receiving hemodialysis with symptoms of depression and/or anxiety.SettingThe study took place at hemodialysis centers in 4 tertiary-care hospitals in Montreal, Canada.ParticipantsParticipants included adults aged ≥18 years who were receiving in-center hemodialysis 3 times per week and had symptoms of depression and/or anxiety as indicated by a score ≥6 on the Patient Health Questionnaire-9 (PHQ-9) and/or the General Anxiety Disorder-7 (GAD-7).MethodsParticipants were randomized to the treatment arm (BMI) or the active control arm (HEP) and completed assessments at baseline, 8 weeks, and 6-month follow-up. Depression was assessed using the PHQ-9, and anxiety was assessed by the GAD-7. Hospitalization rates were assessed using medical chart information.ResultsWe observed significant decrease in depression scores over 6 months in both BMI and HEP groups, with no significant difference between groups. Anxiety scores significantly decreased over 6 months, but only in the BMI group. Brief Mindfulness Intervention and Health Enhancement Program were comparable in terms of hospitalization rates.LimitationsThe limitations of our study include the modest sample size and lack of a third arm such as a waitlist control.ConclusionsOur results suggest that the beneficial effects of BMI and HEP for improving mood disorder symptoms in patients receiving dialysis persist at 6-month follow-up. Both interventions showed sustained effects for depressive symptoms, but BMI may be more useful in this population given its efficacy in reducing anxiety symptoms as well.Trial registrationPrior to recruitment, the trial had been registered (ClinicalTrials.gov Identifier: NCT03406845).

Project description:BackgroundThe COVID-19 pandemic has increased the level of anxiety among Indonesian senior high school teachers, who face challenges to treat their mental disorder symptoms that arise during their working hours, as mental health services in Indonesia are limited. Therefore, it is vital to equip schoolteachers in Indonesia with early interventions that are easily available, private, and affordable, and 1 feasible approach is to deploy a smartphone mobile app.ObjectiveThe objectives of this study are (1) to evaluate the feasibility of a brief mindfulness-based mobile app (BM-MA) for Indonesian senior high school teachers experiencing anxiety and stress and (2) to examine the effects of using the BM-MA on anxiety, stress, life satisfaction, self-efficacy, trait mindfulness, self-compassion, and physical and social dysfunction among the participants.MethodsWe followed the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement for this feasibility randomized controlled trial (RCT) protocol. A total of 60 Indonesian senior high school teachers were recruited for this study and randomly assigned to either the intervention group (BM-MA) or a wait-list control group (CG) in a 1:1 ratio. The BM-MA group was required to engage in mindfulness practices using the app for 10-20 minutes per day for 3 weeks. All participants were assessed with a battery of self-report measures at baseline, postintervention, and at 1-month follow-up. Validated scales used to measure the outcome variables of interest included the Satisfaction With Life Scale (SLS), the Teachers' Sense of Efficacy Scale (TSES), the Self-Compassion Scale-Short Form (SCS-SF), Generalized Anxiety Disorder-7 (GAD-7), General Health Questionnaire-12 (GHQ-12), and the Five Facet Mindfulness Questionnaire (FFMQ). The practicality and acceptability of the app will be evaluated using the Client Satisfaction Questionnaire-8 (CSQ-8) and structured qualitative interviews. Data from the interviews will be analyzed with the deductive thematic analysis framework as a process of qualitative inquiry. Repeated measures ANOVA with groups (intervention vs control) as a between-subject factor and time as a within-subject factor (baseline, postintervention, and 1-month follow-up) will be used to examine the effects of the BM-MA on the outcome variables. The data will be analyzed using an intent-to-treat approach and published in accordance with CONSORT (Consolidated Standards of Reporting Trials) recommendations.ResultsParticipants were recruited in December 2023, and this pilot RCT was conducted from January through March 2024. Data analysis was conducted from March through May 2024. The results of this study are expected to be published in December 2024. The trial registration of this protocol was submitted to the Chinese Clinical Trial Registry.ConclusionsThis study aims to determine the feasibility and efficacy of the BM-MA, a digital mental health intervention developed using an existing mindfulness-based app, and assess its potential for widespread use.Trial registrationChinese Clinical Trial Registry ChiCTR2300068085; https://tinyurl.com/2d2x4bxk.International registered report identifier (irrid)DERR1-10.2196/56693.

Project description:BackgroundPsychological distress in University settings has grown and became a public health concern. In this context, contemplative practices such as mindfulness have been proposed as a strategy to help students on stress management.MethodsForty university students (20 female), aged between 18 to 30 years (mean = 24.15; SD = 3.56), with no previous experience with meditation or yoga were recruited at the Federal University of Rio Grande do Norte and randomized to a mindfulness training (MT) or active control (AC) groups. We analyzed measures of anxiety, affect, stress, as well as state and trait mindfulness in order to evaluate the effects of trait mindfulness and a brief mindfulness intervention in forty healthy young students. Participants were classified as Low (n = 27, females = 13) or High (n = 13, females = 7) Trait Mindfulness by k-means clustering and compared between them using Wilcoxon sum rank test. Furthermore, the sample was randomly allocated to an AC (n = 20, females = 10) or a MT (n = 20, females = 10) group, and mixed analysis of variance was performed to analyze the effect of interventions. The mechanisms and role of trait mindfulness in the intervention was assessed by a moderated mediation analysis.ResultsWe found that High Trait individuals have lower anxiety trait, anxiety state and perceived stress levels. Only the MT group reduced their anxiety state and perceived stress after the intervention and increased their state mindfulness. Both groups reduced negative affect and cortisol, and no change was found in positive affect. Moderated mediation analysis showed that the training-induced change in state mindfulness mediated the increase in positive affect and the decrease in perceived stress and cortisol, regardless of trait mindfulness. For anxiety state the decrease only occurred in individuals with High Trait Mindfulness.ConclusionsTogether, these results suggest that higher trait mindfulness is associated with low levels of psychological distress and that a brief mindfulness-based intervention seems to be useful to reduce distress measures in university students.Trial registrationReBEC, U1111-1194-8661. Registered 28 March 2017-Retrospectively registered, http://www.ensaiosclinicos.gov.br/rg/RBR-7b8yh8.

Project description:ObjectivesAvoiding touching the eyes, nose, and mouth (T-zone) is a strategy to reduce the spread of COVID-19. This study evaluated the effectiveness of a brief mindfulness-based intervention (MBI) named "STOP (Stop, Take a Breath, Observe, Proceed) touching your face" for reducing face-touching behavior.MethodsIn this online-based, two-arm, wait-list, randomized controlled trial, eligible participants were randomly assigned to the intervention (n = 545) or control group (n = 545). The results of 60-min self-monitoring of face-touching behavior were reported before and after the intervention. Reduction of the percentage of T-zone touching was the primary outcome, and reduction of face-touching frequency was a key secondary outcome. Outcomes were analyzed on an intention-to-treat (ITT) basis with a complete case analysis (CCA).ResultsITT analysis revealed that the percentage of T-zone touching was significantly reduced by 8.1% in the intervention group (from 81.1 to 73.0%, RR = 0.901, OR = 0.631, RD = - 0.081, p = 0.002), and insignificantly reduced by 0.6% in the control group (from 80.0 to 79.4%, p = 0.821). Fewer participants performed T-zone touching in the intervention group than in the control group (73.0% vs. 79.4%, RR = 0.919, OR = 0.700, RD = - 0.064, p = 0.015) after the intervention, and there was a greater reduction of T-zone touching frequency in the intervention group than in the control group [mean ± SD: 1.7 ± 5.13 vs. 0.7 ± 3.98, mean difference (95% CI): 1.03 (0.48 to 1.58), p < 0.001, Cohen's d = - 0.218]. The above results were further confirmed by CCA.ConclusionsThis brief mindfulness-based intervention was potentially effective at reducing the spread of COVID-19 and could be further investigated as an intervention for preventing other infectious diseases spread by hand-to-face touching.Trial registrationClinicalTrials.gov NCT04330352.Supplementary informationThe online version contains supplementary material available at 10.1007/s12671-022-02019-x.

Dataset Information

Brief Mindfulness Intervention vs. Health Enhancement Program for Patients Undergoing Dialysis: A Randomized Controlled Trial.

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Brief Mindfulness Intervention vs. Health Enhancement Program for Patients Undergoing Dialysis: A Randomized Controlled Trial.

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