Short summary

Eating Disorders (EDs) are mental disorders with long recovery time and high mortality. Despite the importance and extensive research in the field, an effective treatment for EDs has yet to be found. In co-production with ED patients, clinicians, and technology experts a Serious Game called "Maze out" was developed and initially evaluated through a feasibility study. Maze out is an innovative first player tool focusing on improving self-efficacy, mutual understanding, and family functioning.

Rationale

Eating disorders (EDs) - anorexia nervosa, bulimia nervosa, and binge eating disorder - are serious mental disorders characterized by symptoms with several behavioral features, such as: purging, bingeing, restricting, and cognitive-affective (e.g., feelings of fatness, fear of weight gain). Among European women <1-4% suffer from anorexia nervosa, <1-2% from bulimia nervosa, and <1-4% of binge eating disorder during their lifetime. In men, 0.3-0.7% report eating disorders (Keski-Rahkonen & Mustelin, 2016).

EDs are complex disorders associated with notable impairment to quality of life, impacting personal, and social life (Jenkins, Hoste, Meyer, & Blissett, 2011; Mitchison, Hay, Slewa-Younan, & Mond, 2012; Mond, Hay, Rodgers, & Owen, 2012). They are characterized by high comorbidity such as anxiety disorders (>50%), mood disorders (>40%), and self-harm (>20%) (Keski-Rahkonen & Mustelin, 2016). Hilde Bruch (1904-1984), a German-born American psychiatrist and psychoanalyst, and probably the most influential and important figure in the field of EDs (Skårderud, 2013), describes the main psychopathological phenomena of ED as lack of awareness of inner experiences and failure to rely on feelings, thoughts and bodily sensations to guide behavior, which may contribute to the experience of a sense of not living one's own life (Bruch, 1962). Therefore, many individuals with ED describe a powerful experience of stress and inner unrest, or "chaos" (Robinson, Skårderud, & Sommerfeldt, 2019)

1.1 Treatment for ED Despite the importance and extensive research in the field, an effective treatment for EDs has yet to be found. The current recommended treatment worldwide is a combination of nutritional treatment with different forms for supportive therapy or psychotherapy (Hilbert, Hoek, & Schmidt, 2017; National Institute for Care end Excellence (NICE), 2017; Resmark, Herpertz, Herpertz-Dahlmann, & Zeeck, 2019; Yager et al., 2014). Up to half of the patients with EDs never fully recover after treatment, and there is thus an urgent need for improved treatment outcomes across the field of EDs (Murray, 2019; Steinhausen, 2002). Evidence-based practice in EDs incorporates three essential components: research evidence, clinical expertise, and patients' perspective (Peterson, Becker, Treasure, Shafran, & Bryant-Waugh, 2016; Sackett, Rosenberg, Gray, Haynes, & Richardson, 1996). These components of evidence-based practice are considered essential for providing optimal care in the treatment of EDs (Peterson et al., 2016). However, in academic research focusing on EDs input from patients and clinicians, is often missing (Treasure, 2019). The biggest challenges for clinicians in the treatment of EDs, is the patients' lack of insight into their own disorder, ambivalence towards recovery, high dropout rates, and weak working alliances (Robinson et al., 2019). Ambivalence to recovery and lack of insight into their own disorder can partly be explained by the ego-syntonic aspects of EDs. Individuals who are undiagnosed and diagnosed with an ED, do not, often, identify themselves with a clinical label or as having a mental illness (Lavis, 2011; Warin, 2009). Furthermore, people suffering from ED face significant barriers to treatment such as stigma, access, and affordability depending on the healthcare system and government support (Kazdin, Fitzsimmons-Craft, & Wilfley, 2017). Patients suffering from EDs present a large variation in the clinical presentation in those in the early phase of onset compared to those with a more severe lasting form of ED. This among other things implies the need for a personalized treatment approach (Treasure, 2019). Overall, the complexity of EDs and the diversity of human circumstances and preference thus calls for a range of well-designed tools that practitioners and other health care professionals can choose from (Murray, 2019). Playing and tools that involve playing may contribute to find new perspectives and insight that cannot be reached in a therapeutic seance. Playing provide a context for learning in a fun way. Games appeal to aspects that render learning effective, that stimulate association and use of multiple senses (de Wit-Zuurendonk & Oei, 2011). Serious games are therefore interesting from a clinical perspective.

1.2 Serious games Serious games (SG) are digital games and simulating tools that are created for non-entertainment use, but with the primary purpose to improve skills and performance of play-learners through training and instruction (Loh, Sheng, & Ifenthaler, 2015). SG are gaining acknowledgment in health and mental health treatment (Botella et al., 2011; Bul et al., 2016; DeSmet et al., 2014; Fleming et al., 2016; Li, Theng, & Foo, 2014), probably because of factors like play which is inheritably fun. It also permits to look at a troublesome matter with curiosity while trying new paths without too much risk. The most important perceived advantages of SG are 1) they are perceived as fun with optimal flow-state balance functioning as drivers for motivation, 2) a safe environment to perform high-stake actions, 3) immediate, unbiased system feedback, especially well-suited to learn knowledge and partial tasks (but not complex operations) (Teschner, 2016). The main challenges of SG are validation issues, high development costs, lack of multi-stakeholder approach and institutional, professional, and individual barriers/fears towards implementing a new, innovative learning method, with accompanied high costs for preparation and training (Teschner, 2016). In theory, SG may influence learning in two ways: by changing the cognitive processes and by affecting the motivation (Malone, 1981).

1.3 Digital treatment technologies Overall, digital technologies enable new insights to be gained into the lived experience of mental disorder. This enables current treatments to be refined and personalized, as well as generating new targets for future treatment development (Griffin & Saunders, 2020). Serious games by means of digital technology have been used in mental health care in various formats. Albeit not considered as a game as such, the use of Virtual reality (VR) as a therapeutic tool has been shown to be acceptable for patients with EDs (Clus, Larsen, Lemey, & Berrouiguet, 2018). One pilot study was examined as a complementary tool in EDs and impulse control disorders, but without patient active involvement in the production of the game. The short terms effects after using this video game strategy for 12-14 weekly sessions, showed that patients started to show new ways of coping with negative emotions in normal stress life situations. Additionally, more generalization patterns and more self-control strategies were shown when confronted with them. The conclusion was that games may be a positive option to complement treatment of EDs (Fernandez-Aranda et al., 2012). Mobile apps for health (MH apps) also have the potential to expand access to information and support, especially for people who are unable to access face-to-face care. The role of these apps is becoming especially salient during the ongoing COVID-19 crisis (Wasil, Gillespie, Schell, Lorenzo-Luaces, & DeRubeis, 2021). Although apps are a relatively recent invention in the field of health, there are a huge number of them (Fairburn & Rothwell, 2015; Melbye, Kessing, Bardram, & Faurholt-Jepsen, 2020), however, evaluating the effectiveness and potential usability of MH apps is poorly studied (Melbye et al., 2020). The most studied app is a self-monitoring app, Recovery Record (Tregarthen, Lock, & Darcy, 2015), where results suggest that such an intervention is highly accepted by patients with anorexia nervosa and that it could support symptom stabilization or continued improvement as an add-on therapy to treatment as usual, if used therapist-guided (Keshen et al., 2020; Neumayr, Voderholzer, Tregarthen, & Schlegl, 2019). As far as we know no smartphone app for EDs, involving serious games, has been developed, tested, or evaluated for its effectiveness, alone or in addition to TAU.

1.4 The aspect of playing Using digital games in mental health invites patients to play. Although playing games is a typical activity amongst children, it is also an expression of an inner drive that can give patients the opportunity to contact their potential. Playing is "as if", the playful element of games, allows patients to prepare for something they both want and fear - to get well. According to Winnicott, a well-known English pediatrician and psychoanalyst, it is in playing and in playing only that the individual child or adult is able to be creative and to use the whole personality, and it is only in being creative that the individual discovers the self (Winnicott, 1971). In the landscape that Winnicott draws, the toy is manufactured inside the playful process; it means that although we give the child toys, he or she can only activate them and make them work as such. Winnicott also postulate it is creative apperception more than anything else that makes the individual feel that life is worth living. In contrast with this is the relationship with external reality, which is one of compliance, the world and its details being recognized but only as something to be fitted in with or demanding adaptation (Winnicott, 1971).

1.5 User involvement in the development of the technologies Whilst the impact of digital technologies is likely to be positive, actively seeking to involve patients in the development of such technologies to fit their needs and providing adequate training and support for those using the devices and apps is likely to be key to the success of digital approaches (Griffin & Saunders, 2020). As far as we know none of the current available apps for people with EDs has involved patients in the development of it. Serious games by means of mobile applications has not been tried in EDs, and neither have these games been developed in close collaboration with the patients themselves. Since patient and clinician involvement may increase the feasibility and appropriateness for the patients (Kazdin et al., 2017; Treasure, 2019), we decided to involve patients suffering from ED and clinicians working with ED, in developing a serious game that could be added to TAU.

1.6 Mobile Health Game: Maze out Developing an evidence based serious game to complement treatment for ED involves four steps: 1) development in close collaboration with the patients themselves, 2) feasibility and pilot testing of the game, 3) testing the game's effectiveness, and 4) implementing Maze out across EDs care settings. First step of the process was performed in 2020. The result of this process was Maze Out (Guala, 2021); the first serious game aimed to be a support tool for ED patients and was co-produced with 4 patients suffering from ED, ED specialists, a private gaming production company and one specialist from the center of tele psychiatry. Patients and staff participated in a total of six co-production workshops. The game was constructed as a maze where from it is possible to escape, depending on how a series of situations are solved. The situations and tasks were suggested by the patients involved in the co-production, representing a series of common situations that are hard to tackle when suffering from ED. Maze out is thus supposed to help patients become aware of the contents of the world of ED and experience links between different feelings and behavior choices, and thereby the possibility to gain insight in their inner experiences. In Maze Out, patients are also invited to play with their ambivalence to recover from ED, without investing too much of themselves, exploring the consequences of different choices and behaviors. Maze out can be played on phones or tablets no older than 5 years, running Android or iOS. Maze out can downloads from a link and the player can afterwards save it as an icon in the smartphone/tablet.

Second step in the process was performed primo 2021. When the first prototype of Maze Out was finalized, 20 patients suffering from ED, recruited from the Outpatient Mental Health hospital in Odense were invited to test the feasibility of the game. The patients were asked to fill in a self-efficacy questionnaire at baseline (pre-playing), encouraged to play the game regularly for 8 weeks, and thereafter fill in a self-efficacy questionnaire again (post-playing). After 8 weeks, the patients were also invited to a focus-group or individual interview about how they experienced Maze Out, whether they considered the game to be helpful and if so, in what way. Of the 20 patients, 18 patients filled out pre- and post-playing questionnaire, and 14 participated in the qualitative semi-structured interviews, either in focus-group (10 patients) format or individually (4 patients). In addition, staff members (therapists) were interviewed about their experiences of Maze-out's usability. The conclusion on the feasibility study was that the patients found Maze out easy to use, meaningful and informative in addition to being fun. Most of the patients were thus excited about the game and considered it to be a helpful tool that encouraged reflection. It gave them insight into their coping strategies and made it clear to them that, the only way to avoid being caught up in the same situations again and again was to try-out different coping strategies. The patients also found that Maze Out encouraged contemplation in a different way than did therapy. They appreciated how the game continuously affirmed them and encouraged autonomy. The patients also noted that the game could be used to allow family and network gain insight in the dilemmas that the patients face, and thus became a possible bridge to understanding and improved communication (Guala, 2021). The patients only had a few suggestions on how to improve Maze Out. They suggested adding a function of sending out notifications, to remind patients that it was time for playing. They also suggested adding an algorithm, allowing for personalized versions aimed of specific sub-groups of EDs rather than ED in a broader sense. Similar suggestions for the ideal digital tool was also retrieved from the Randomized control trial on Recovery Record (Tregarthen et al., 2015).

2. AIM OF STUDY The purpose of the present study RCT is to: A) By quantitative methods evaluate the effectiveness of Maze Out on patient self-efficacy (primary outcome), family functioning, perceived help from staff, health literacy, ED symptoms and weight (secondary outcomes). B) By means of qualitative and qualitative methods, investigate further potentials of implementing Maze Out, in particular potential to improve communication and understanding between patients and their network, e.g. family or staff at mental health care homes.

Description of the cohort

3.1.4 Inclusion and exclusion criteria

1) Patients of both sexes aged 18+. 2) A diagnosis of anorexia nervosa, bulimia nervosa, other eating disorders and eating disorders unspecified (ICD-10 codes: F.50.0-F.50.9), 3) The patient is receiving treatment from one of psychiatry centers in the Mental Health Services of Region South Denmark or living in a mental health care institution (psykiatrisk bosted) in Region of Southern Denmark.

2) There are no exclusion criteria. The qualitative study will be performed partly in the Mental Health Services of Region South Denmark, including mental health care homes (psykiatriske bosteder), run by the municipalities in Region South Denmark and partly with significant others of patients suffering from ED.

3.2.2 Study procedure Fifteen staff members and care giving staff, who work with patients suffering from ED, who participate in the effectiveness study (A) and identified by the patients, will be invited to participate in qualitative individual/focus group interviews. Fifteen significant others of patients suffering from ED, who participate in the effectiveness study and identified by the patients, will likewise be invited to participate in qualitative individual/focus group interviews.

Data and biological material

Data collection At baseline, data on age, gender, height, employment, kids, comorbidity, length of illness and previous treatment participation in addition to data on weight, height, ED symptoms, BMI (Body Mass Index), EDI 3 (Eating Disorders Inventory) GAF-score (Global Assessment of Functioning), , MHLS (The Mental Health Literacy Scale), The General Self-Efficacy Scale (GSE), Brief INSPIRE (measuring perceived help received from staff), Family APGAR (family function), and SABS (Structural Analysis of Social Behavior Questionnaire) will be collected. Except the socio-demographic data, the same data will be collected after 15 weeks and again after 6 months. Data on time spend playing during the 15 weeks will be collected from the game back end. Patients will complete the questionnaires virtually by e-boks, or on a tablet in the information meeting if they prefer that Questionnaires in paper format will be offered as an alternative if the patients wish. Questionnaires will be collected and managed using RedCap (Research Electronic Data Capture). RedCap is a secure, web-based application designed to support data capture for research studies. RedCap complies with Danish legislation on processing personal data. Access to study data will only be available for data managers. Interview-based data will be written directly into RedCap by the researcher. Information on diagnosis, hospital admissions, treatment duration and adherence to treatment appointments will be collected retrospectively and retrieved from the patient case notes.

Data collection and analysis for the qualitative part: Thematic content analysis will be conducted within a realist methodological framework (Braun & Clarke, 2006). The analysis will be theoretical as it will be driven explicitly by the analyst from specific research questions, in contrast to questions evolving during the coding (i.e. an inductive approach). A theme in thematic content analysis represents both patterned responses and meanings which captures something important to the research questions, but is not dependent on quantifiable measures (Braun & Clarke, 2006). In line with the theoretical approach, the identification of themes will be done on a semantic level with grouping of explicit meanings and statements (Boyatzis, 1998). This implies, that a unidirectional relationship is assumed between the statements of the participants and their meaning and/or motivations (Potter & Wetherell, 1987; Widdicombe & Wooffitt, 1995). The semantic patterns, or themes, will thus be summarized based on their surface meaning and the interpretation of these themes will be done focusing both on their explicit meaning but also on their implications and broader importance (Patton, 1990). Coding will be conducted using a concept map encompassing the topics of interview guide relating to the overall research questions. Codes will then be grouped into semantic themes and organized according to the overall topics during the analysis process.