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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.
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.
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.
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.
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.
PRR1-10.2196/20819
Recent developments in interventions for depression and the prevention of its relapse have focused on applying mindfulness-based strategies, which aim to shift the focus of attention away from the negative content of thought to nonjudgmentally observe the mind processes [
MBAT is based on the self-regulation theory and integrates mindfulness skills and aspects of art therapy into an 8-week, gender-segregated, supportive group therapy format [
Our research draws from previous scientific investigation of the benefits of mandala coloring for mental health [
It has been shown that mindfulness practice and the development of mindfulness expertise is closely linked to increased awareness of the body and its sensations [
During the practice of mandala coloring, individuals need to focus on the coloring process, as the complex design provided by the mandalas requires a high concentration level. Small areas have to be colored with small and conscious movements [
Recently, brain-computer interfaces (BCIs) have also been used to support the self-regulation of attention during mindfulness practices. For instance, MeditAid is an interactive system that uses neurofeedback during mindfulness sitting meditation to support the self-regulation of attention [
The main objective of this research is to evaluate the impact of a novel mindfulness-based interactive technology (ie, Anima) on the mental well-being of people who have experienced depression.
The main research questions we seek to answer are the following: (1) To what extent can the materialization of brain activity using Anima facilitate the training of a mindfulness state for people who have depression? (2) To what extent does exposure to the training program positively influence the training of acceptance, self-awareness, and regulation of attention and emotions? (3) Does the use of Anima decrease depressive symptoms and increase mental well-being for people who have experienced depression?
The primary outcome is increased mental well-being after the study in comparison to baseline. The secondary outcomes are improved acceptance, self-awareness, and self-regulation of attention and emotional strategies and increased trait mindfulness at the end of the study.
According to Jung, the psychotherapist that introduced mandala coloring to Western culture, the anima represents the inner personality, which allows the individual to bring attention toward unconscious parts of the self [
Anima consists of 3 main components that have been carefully designed to fulfill a specific goal during its use (
Second, the adaptive color palette is used as a peripheral interface to monitor the practice, as it provides new colors that are generated based on the current mindfulness state. The color palette is a hybrid object consisting of a tablet enclosed in a bespoke, wooden painter palette that adaptively provides a generative set of 22 colors from the user’s brain activity via an Android app we developed. The palette aims to subtly reflect the mental states involved in the unfolding mandala-coloring practice and to explore the ways that such materializations of mental states support mindfulness practice. When a color is selected from Anima’s generative palette (by tapping it), the canvas automatically loads it to color the digital mandala.
Finally, the canvas aims to recreate the traditional practice of mandala coloring to train focused attention. The canvas used to color the mandala consists of a tablet that displays a mandala from a website we developed and can be colored using a stylus. The color selected from the palette's Android app is automatically sent to the mandala canvas using web sockets, and it becomes available for coloring immediately.
This diagram shows an overview of the system by describing the 3 components of Anima (ie, brain activity headband, adaptive color palette, and mandala-coloring canvas) and their integration. EEG: electroencephalogram; MF: mindfulness; RGB: red, green, and blue; SDK: software development kit.
In this study, we will follow the well-established methodology of a single-case experimental design (SCED). A SCED is an experimental research design in which an individual case serves as its own control, and the dependent variable measured is analyzed for each individual case and is not averaged across groups or across participants. This methodology emphasizes intensive repeated observations of a particular participant to demonstrate precise control over targeted behavior and includes a family of methods in which each participant serves as his or her own control [
The multiple-baseline experimental design is a SCED in which a treatment is successively administered over time to different participants for different behaviors or in different settings. That is, in multiple-baseline designs, multiple AB data series are compared, and the introduction of the intervention is staggered across time. Comparisons are made both between and within data series. Adding phase repetitions increases the power of the statistical test, similar to adding participants in a traditional group design [
The changing criterion design is a SCED in which a baseline phase is followed by successive treatment phases in which some criterion or target level of behavior is changed from one treatment phase to the next. The participant must meet the criterion of the treatment phase before the next treatment phase is administered. Thus, the changing criterion design is used to determine the effects of an independent variable when the final version of the target behavior cannot be emitted initially. Experimental control is demonstrated by the repeated changes in the dependent measure as the criterion is changed [
To sum up, the flexibility of SCED allows for greater freedom to ask innovative questions about novel treatments and has been widely used as an initial research design for testing innovative research in, for example, behavioral sciences [
This training intervention will be carried out in the homes of eligible consenting participants. Participants will be asked to color a mandala using Anima (
A person using Anima. While wearing the electroencephalography headband, colors based on the current mental states are generated on the wooden palette and can be used to color the digital mandala.
Following previous studies evaluating the effect of mindfulness-based programs for health in general and depression in particular [
Mindfulness
For state mindfulness [
For trait mindfulness [
Research has shown that the MAAS taps into a unique quality of consciousness that is related to and predictive of a variety of self-regulation and well-being constructs. It has also been found that the greater the change in mindfulness, the greater the reduction in depressed mood and the extent to which participants deal with difficulties through rumination and avoidance [
The Beck Depression Inventory second edition (BDI-II) is a 21-item scale and one of the most widely used self-report measures of depression [
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) [
Private self-consciousness and the subordinate constructs of self-reflection and insight are key factors in the self-regulatory process underpinning the creation of behavior change in both clinical and nonclinical environments, and they can be assessed with the Self-Reflection and Insight Scale (SRIS) [
The Self-Assessment Manikin (SAM) is a widely used nonverbal pictorial assessment technique used to obtain self-assessments of emotional state on the dimensions of affective valence, arousal, and dominance [
User experience will be measured indirectly by how often participants use the prototype and directly during the interviews and using the User Experience Questionnaire (UEQ) after each session [
The study will have 3 phases (as shown in
The intervention phase will last 8 weeks for all participants, starting at different points in time. Every week, they will be asked to practice mandala coloring using Anima 3 times. Each session will last between 70 and 75 minutes, as shown in
Further, a short face-to-face semistructured interview will take place every 2 weeks with each participant to check that the technology is working and to gather qualitative data on their experience, both for the evaluation of user experience with Anima and for their mandala-coloring practice evolution.
Timeline of the protocol, starting with N weeks of baseline per participant, followed by 8 weeks of intervention and 4 weeks of postintervention monitoring.
Triweekly mandala-coloring sessions during the intervention phase (in blue in Figure 3). To evaluate the effect of mandala coloring, data collection in each session will include pre- and post-EEG and measurements of emotional state (ie, SAM), mindfulness state (ie, TMS), and user experience (ie, UEQ-S). Trait measurements will be collected once a week. Hence, questionnaires will be distributed during the 3 sessions: BDI-II for depression symptoms in the first session, MAAS for trait mindfulness and WEMWBS for mental well-being in the second session, and SRIS for acceptance and reflection in the third session. BDI-II: Beck Depression Inventory second edition; EEG: electroencephalography; MAAS: Mindful Attention Awareness Scale; SAM: Self-Assessment Manikin; SRIS: Self-Reflection and Insight Scale; TMS: Toronto Mindfulness Scale; UEQ-S: User Experience Questionnaire short version; WEMWBS: Warwick-Edinburgh Mental Well-being Scale.
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 [
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.
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.
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).
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 [
The method followed in this study is the well-established purposeful sampling method [
Single-case experimental designs emphasize intensive repeated observations of a particular subject to demonstrate precise control over the targeted behavior [
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.
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 [
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).
Peer-review reports (1).
Peer-review reports (2).
brain-computer interface
Beck Depression Inventory second edition
electroencephalography
Mindful Attention Awareness Scale
mindfulness-based art therapy
National Health Service
Self-Assessment Manikin
single-case experimental design
Self-Reflection and Insight Scale
Toronto Mindfulness Scale
User Experience Questionnaire
Warwick-Edinburgh Mental Well-being Scale
This work has been supported by AffecTech: Personal Technologies for Affective Health, Innovative Training Network, which is funded by the H2020 People Programme (Marie Skłodowska-Curie GA No. 722022).
None declared.