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A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©.

ABSTRACT: BACKGROUND:Epilepsy extends far beyond seizures; up to 80% of children with epilepsy (CWE) may have comorbid cognitive or mental health problems, and up to 50% of parents of CWE are at risk for major depression. Past research has also shown that family environment has a greater influence on children's and parents' health-related quality of life (HRQOL) and mental health than epilepsy-related factors. There is a pressing need for low-cost, innovative interventions to improve HRQOL and mental health for CWE and their parents. The aim of this randomized controlled trial (RCT) is to evaluate whether an interactive online mindfulness-based intervention program, Making Mindfulness Matter (M3), can be feasibly implemented and whether it positively affects CWE's and parents' HRQOL and mental health (specifically, stress, behavioral, depressive, and anxiety symptoms). METHODS:This parallel RCT was planned to recruit 100 child-parent dyads to be randomized 1:1 to the 8-week intervention or waitlist control and followed over 20?weeks. The intervention, M3, will be delivered online and separately to parents and children (ages 4-10?years) in groups of 4-8 by non-clinician staff of a local community epilepsy agency. The intervention incorporates mindful awareness, social-emotional learning skills, and positive psychology. It is modeled after the validated school-based MindUP program and adapted for provision online and to include a parent component. DISCUSSION:This RCT will determine whether this online mindfulness-based intervention is feasible and effective for CWE and their parents. The proposed intervention may be an ideal vector to significantly improve HRQOL and mental health for CWE and their parents given its low cost and implementation by community epilepsy agencies. TRIAL REGISTRATION:ClinicalTrials.gov NCT04020484 . Registered on July 16, 2019.

SUBMITTER: Puka K

PROVIDER: S-EPMC7657360 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©.

Puka Klajdi K Bax Karen K Andrade Andrea A Devries-Rizzo Margo M Gangam Hema H Levin Simon S Nouri Maryam N MN Prasad Asuri N AN Secco Mary M Zou Guangyong G Speechley Kathy N KN

Trials 20201111 1

<h4>Background</h4>Epilepsy extends far beyond seizures; up to 80% of children with epilepsy (CWE) may have comorbid cognitive or mental health problems, and up to 50% of parents of CWE are at risk for major depression. Past research has also shown that family environment has a greater influence on children's and parents' health-related quality of life (HRQOL) and mental health than epilepsy-related factors. There is a pressing need for low-cost, innovative interventions to improve HRQOL and men ...[more]

PMID: 33176853

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Project description:ObjectivesThe goal of the present study was to probe the effects of mindfulness practice in a naturalistic setting as opposed to a lab-based environment in the presence of continuous heart rate variability (HRV) measurements. The specific experimental goals were to examine the effects of a brief 10-day online-based mindfulness intervention on both chronic and acute HRV responses.MethodWe conducted a fully randomized 10-day longitudinal trial of mindfulness practice, explicitly controlling for practice effects with an active-control group (music listening) and a non-intervention control group. To assess chronic cardiovascular effects, we asked participants in the 3 groups to complete 2-day HRV pre- and post-intervention measurement sessions. Using this experimental setup enabled us to address training effects arising from mindfulness practice to assess physiological impact on daytime as well as nighttime (i.e. assessing sleep quality) on the underlying HRV response. To assess acute cardiovascular effects, we measured HRV in the 2 active intervention groups during each of the 10 daily mindfulness or music sessions. This allowed us to track the development of purported training effects arising from mindfulness practice relative to the active-control intervention in terms of changes in the HRV slope over the 10-day time-course.ResultsFirstly, for the acute phase we found increased HRV during the daily practice sessions in both the mindfulness and active-control group indicating that both interventions were effective in decreasing acute physiological stress. Secondly, for the chronic phase we found increased HRV in both the day- and nighttime indicating increased sleep quality, specifically in the mindfulness group.ConclusionThese results suggest causal effects in both chronic and acute phases of mindfulness practice in formerly naïve subjects and provides support for the argument that brief online-based mindfulness interventions exert positive impact on HRV.

Project description:BACKGROUND:Psychological distress during pregnancy is common: up to 20% of the childbearing women experience symptoms of depression and anxiety. Apart from the adverse effects on the woman herself, pregnancy distress can negatively affect pregnancy outcomes, infant health, postpartum mother-child interaction and child development. Therefore, the development of interventions that reduce pregnancy distress is very important. Mindfulness-based interventions (MBIs) show promising positive effects on pregnancy distress, but there is a need for randomized controlled trials with sufficient power. Trials on online MBIs, which are readily accessible and not expensive, also show positive effects on stress reduction in non-pregnant populations. Moreover, specific working mechanisms of MBIs remain unclear. The aim of the current study is to test the effectiveness of an online MBI in pregnant women with pregnancy distress, as well as exploring potential working mechanisms. METHODS:The current study is a randomized controlled trial with repeated measures. Consenting women with elevated levels of pregnancy distress will be randomized into an intervention group (MBI) or control group (care as usual) around 12?weeks of pregnancy, with an intended sample size of 103 women in each group. The primary outcome, pregnancy distress, will be assessed via questionnaires at baseline, halfway through the intervention and post intervention in both intervention and control group, and after 8 weeks follow-up in the intervention group. Secondary outcomes are mindfulness skills, rumination and self-compassion, which are also seen as potential working mechanisms, and will be assessed via questionnaires before intervention, halfway through the intervention, post intervention and after 8 weeks follow-up in the intervention group. Tertiary outcome variables are obstetric data and will be collected from the obstetric records for both intervention and control group. Analyses will be based on the intention-to-treat principle. Multilevel regression models for repeated measures (mixed models) will be used to evaluate changes in primary and secondary outcome variables. Tertiary outcomes will be compared between groups using independent t-tests and Chi Square analyses. DISCUSSION:The trial is expected to increase knowledge about the effectiveness of online MBIs during pregnancy in women with pregnancy distress and to evaluate potential working mechanisms. TRIAL REGISTRATION:ClinicalTrials.gov: NCT03917745, registered on 4 March 2019. Protocol Version 3.0., 20 February 2020.

Project description:BACKGROUND:Depression is common among persons with epilepsy (PwE), affecting roughly one in three individuals, and its presence is associated with personal suffering, impaired quality of life, and worse prognosis. Despite the availability of effective treatments, depression is often overlooked and treated inadequately in PwE, in part because of assumed concerns over drug interactions or proconvulsant effects of antidepressants. Internet-administered psychological interventions might complement antidepressant medication or psychotherapy, and preliminary evidence suggests that they can be effective. However, no trial has yet examined whether an Internet intervention designed to meet the needs of PwE can achieve sustained reductions in depression and related symptoms, such as anxiety, when offered as adjunct to treatment as usual. METHODS/DESIGN:This randomized controlled trial will include 200 participants with epilepsy and a current depressive disorder, along with currently at least moderately elevated depression (Patient Health Questionnaire (PHQ-9) sum score of at least 10). Patients will be recruited via epilepsy treatment centers and other sources, including Internet forums, newspaper articles, flyers, posters, and media articles or advertisements, in German-speaking countries. Main inclusion criteria are: self-reported diagnosis of epilepsy and a depressive disorder, as assessed with a phone-administered structured diagnostic interview, none or stable antidepressant medication, no current psychotherapy, no other major psychiatric disorder, no acute suicidality. Participants will be randomly assigned to either (1) a care-as-usual/waitlist (CAU/WL) control group, in which they receive CAU and are given access to the Internet intervention after 3 months (that is, a CAU/WL control group), or (2) a treatment group that may also use CAU and in addition immediately receives six-month access to the novel, Internet-administered intervention. The primary outcome measure is the PHQ-9, collected at three months post-baseline; secondary measures include self-reported anxiety, work and social adjustment, epilepsy symptoms (including seizure frequency and severity), medication adherence, potential negative treatment effects and health-related quality of life. Measurements are collected online at pre-treatment (T0), three months (T1), six months (T2), and nine months (T3). DISCUSSION:Results of this trial are expected to extend the body of knowledge with regard to effective and efficient treatment options for PwE who experience elevated depression and anxiety. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02791724 . Registered 01 June 2016.

Project description:Introduction: Many of the sleep problems experienced by children with epilepsy (CWE) have the same behavioural basis as common sleep problems seen in typically developing (TD) children. Behavioural sleep interventions (BSIs) are widely used to treat these sleep problems in TD children and are hypothesised to be effective for CWE. However, specific considerations need to be addressed and incorporated into a BSI for CWE to ensure the intervention is tailored to this population's needs. This paper details developing and tailoring an online BSI for parents of CWE, to be used in the CASTLE (Changing Agendas on Sleep, Treatment and Learning in Epilepsy) Sleep-E clinical trial. Method: In phase one, two existing theory-driven paediatric BSIs were adapted into a novel online behavioural sleep intervention (CASTLE Online Sleep Intervention or COSI) which specifically incorporated the needs and requirements reported by nine parents of CWE. Scoping their needs included conducting interviews with three CWE so that they could contribute to the overall intervention content. In phase two, six of these parents evaluated COSI, reviewing and feeding back on COSI until parental approval for content and functionality was achieved. Results: In phase one, a range of adaptations was made to the content and presentation of standardised intervention material to acknowledge and emphasise the key seizure-specific issues to ensure COSI best met parents of CWE's needs. Adaptations included embedding parent and child experiences in the intervention, including particular information requested by parents, such as the links between sleep and seizures and managing child and parental anxieties around sleep, as well as developing functionality to personalise the delivery of content. In phase two, parents confirmed that they found the final version of COSI to be functional and appropriate (after one round of review) for use by parents of CWE and that 100% would recommend it to other families who have CWE. Discussion: It is hoped that the use of evidence-based BSIs, adapted to consider salient epilepsy-specific factors, will increase parent-engagement, COSI's relevance for this particular patient group and overall efficacy in improving sleep in CWE. The effectiveness of COSI will be tested in the CASTLE Sleep-E clinical trial (https://castlestudy.org.uk/).

Dataset Information

A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©.

Publications

A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©.

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