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Lancashire Care NHS Foundation Trust provides health and wellbeing services that includes community services such as community nursing, health visiting, podiatry, sexual health and dentistry, as well as inpatient and community mental health services. It is based in Preston, England.

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A Mindfulness-Based Brain-Computer Interface to Augment Mandala Coloring for Depression: Protocol for a Single-Case Experimental Design

Jan 18, 2021

June 01, 2020 . A Mindfulness-Based Brain-Computer Interface to Augment Mandala Coloring for Depression: Protocol for a Single-Case Experimental Design A Mindfulness-Based Brain-Computer Interface to Augment Mandala Coloring for Depression: Protocol for a Single-Case Experimental Design Authors of this article: Corresponding Author: Lancaster University Abstract Background: The regular practice of mindfulness has been shown to provide benefits for mental well-being and prevent depression relapse. Technology-mediated interventions can facilitate the uptake and sustained practice of mindfulness, yet the evaluation of interactive systems, such as brain-computer interfaces, has been little explored. Objective: The objective of this paper is to present an interactive mindfulness-based technology to improve mental well-being in people who have experienced depression. The system, Anima, is a brain-computer interface that augments mandala coloring by providing a generative color palette based on the unfolding mindfulness states during the practice. In addition, this paper outlines a multiple-baseline, single-case experimental design methodology to evaluate training effectiveness. Methods: Adult participants who have experienced depression in the past, have finished treatment within the last year, and can provide informed consent will be able to be recruited. The Anima system, consisting of 2 tablets and a nonintrusive mental activity headband, will be delivered to participants to use during the study. Measures include state and trait mindfulness, depression symptoms, mental well-being, and user experience, and these measures will be taken throughout the baseline, intervention, and monitoring phases. The data collection will take place in the form of a questionnaire before and after each mandala-coloring session and a semistructured interview every 2 weeks. Trial results will be analyzed using structured visual analysis, supplemented with statistical analysis appropriate to single-case methodology. Results: Study results will offer new insights into the deployment and evaluation of novel interactive brain-computer interfaces for mindfulness training in the context of mental health. Moreover, findings will validate the effectiveness of this training protocol to improve the mental well-being of people who have had depression. Participants will be recruited locally through the National Health Service. Conclusions: Evidence will assist in the design and evaluation of brain-computer interfaces and mindfulness technologies for mental well-being and the necessary services to support people who have experienced depression. International Registered Report Identifier (IRRID): PRR1-10.2196/20819 JMIR Res Protoc 2021;10(1):e20819 Data Analysis The most common method of data analysis in SCEDs consists of conducting a visual analysis to determine intervention effects, as long as the baseline phase has been stable [ 68 , 70 ]. In this case, the stability of a measure is assessed by the consistency in the pattern of change in a dependent measure in each phase of a design. The more stable or consistent changes in a dependent measure are in each phase, the higher the internal validity of the research design. Furthermore, a measure can have a change in level or a change in trend, and the larger the magnitude of change (ie, size of the change in a dependent measure observed between phases of design), the greater the internal validity of the research design. Although there are no specific guidelines for using statistical methods for analyzing SCED data, repeated measurements have been commonly used to evaluate the autocorrelation of sequential observations of the data. However, because of the nature of the SCED method, missing data can occur. Therefore, multilevel modeling and autoregressive moving average methods can be used to overcome these challenges. Results Ethics Approval This study is currently in the process of being submitted to the National Health Service (NHS) to be reviewed by a research ethics committee (Integrated Research Application System number: 262687). Given the current situation and the NHS dealing with a global pandemic, as of summer 2020, we understand that this process may be delayed. We now detail the sample and recruitment process for the study. Inclusion Criteria All adults in the community who (1) are aged between 18 and 60 years, (2) have been diagnosed with mild to moderate depression in the past, (3) have finished treatment within the last year, and (4) are not currently being treated or on a waiting list for psychotherapy for any kind of mental health problem will be initially selected for the study. Further, in order to be included in the study, people will need to (1) show readiness to change, (2) show willingness to engage in self-care, (3) have an interest in interactive mindfulness practices, (4) have internet at home, and (5) have basic knowledge of how to use interactive technology (eg, regular usage of a smartphone, knowing how to connect two devices using Bluetooth). Exclusion Criteria People with (1) motor impairments in the upper part of the body; (2) a major depressive disorder, bipolar disorder, or psychotic disorder based on the Diagnostic and Statistical Manual of Mental Disorders fifth edition criteria; (3) suicidal risk; or (4) a history of a major depressive disorder in the past 6 months according to Kupfer's model [ 96 ] will be excluded. It is also known that medication, drugs, and alcohol can highly affect brain activity [ 97 ]. Therefore, people with signs of alcohol misuse (ie, drinking more than 14 units a week) [ 64 ] and people undergoing a long-term medication treatment will be excluded. Finally, people who have actively engaged in mindfulness practices for the past year (ie, any type of meditation, yoga, tai chi, or qigong) or who score higher than 4 in the MAAS will be excluded from the study, as the number of years of meditation practice is positively related to the MAAS [ 32 ]. Likewise, people who have colored mandalas or adult coloring books more than once a week for the past 6 months will be excluded. Sampling The method followed in this study is the well-established purposeful sampling method [ 98 ], which involves identifying and selecting individuals from a specific population group. In our case, this is people who have recovered from a depressive episode recently and have an interest in mindfulness (detailed description in “Inclusion Criteria” section). Single-case experimental designs emphasize intensive repeated observations of a particular subject to demonstrate precise control over the targeted behavior [ 70 ]. Therefore, these designs usually select a limited number of individuals and collect a considerable amount of data per participant [ 67 ]. Based on previous work following SCED methodology [ 70 ], the estimated sample size for this study is 15 people. Recruitment Participants of this study will be recruited through the Lancashire Care NHS Foundation Trust and will be able to withdraw at any time without justification. This provider will pass the invitation on to eligible residents so they can consider whether they would like to release their contact details to the research group. This study will only include participants who can provide their own informed consent. The service provider handing on the invitation will know whether the person can provide his or her own consent to participate as part of their service agreement with the resident. Discussion This study follows the ethical guidelines and requirements by the European Union, Lancaster University, and the NHS. In terms of data collection and protection, Lancaster University will be the data controller for any personal information collected as part of this study under the General Data Protection Regulation. Further information about how Lancaster University processes personal data for research purposes and about individual data rights can be found on their webpage [ 99 ]. This protocol has been designed alongside a clinical psychologist with expertise in biofeedback from the AffecTech consortium. It was later iterated with the study support service from the National Institute for Health Research Clinical Research Network in the North West. The technology used in this study, Anima, has already been evaluated with the general population in 2 different settings: a public engagement event with mental health professionals in Lancashire and a workshop with people with experience coloring mandalas for mindfulness training and mental well-being (ie, they had been coloring mandalas at least monthly for the last year). 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