Short summary

Maze Out is a new serious game coproduced by patients and therapists.The aims of the present study are to: 1) evaluate the effectiveness of adding Maze Out to treatment as usual (TAU) in a randomised controlled trial; and 2) to explore in depth the potential of Maze Out by examining how it is perceived and used.It is a novel and theoretically well-grounded intervention that may significantly contribute to the healing process of ED. If found effective, the potential for wide-spread impact and dis

Rationale

Eating disorders (EDs) are severe mental health disorders with high mortality, in addition to being costly and associated with serious impairments in quality of life [3-6]. The lifetime prevalence of EDs in Western countries is high with rates of 1.89% across the general population and 2.58% among females [7]. Effective evidence-based treatment of ED is limited [6-9]. The currently recommended treatment for AN and BN in adults is a combination of nutritional care and different forms for psychological interventions and for binge eating disorder (BED) also psychopharmacological treatment [8-13]. The clinical presentation of EDs is complex and depends on both the duration and severity of the disorder, as well as the life circumstances of the patient. Challenges for clinicians include the patients' lack of insight into their own disorder, high dropout rates, ambivalence towards recovery, and weak treatment alliance [14]. Individuals with an ED often do not identify themselves with a diagnostic label or as having a mental disorder [15]. Ambivalence to recovery and lack of insight into their disorder can partly be explained by the ego-syntonic aspects of EDs. On the other hand, many patients develop a sense of helplessness and hopelessness. In such cases, the ambivalence towards recovery may center around having a need to recover from the eating disorder, but at the same time not having a sense of agency, of being able to do anything to get rid of it [16]. Self-efficacy is an individual's belief in his or her capacity to execute behaviors necessary to produce specific performance attainments [17]. Eating Disorders are associated with low self-efficacy and high perfectionism [18, 19]. Furthermore, self-efficacy had shown a negative significant relationship with perfectionism in patients with ED [20]. Self-efficacy has also been shown to be a robust predictor of outcome in several psychiatric disorders and an important predictor of outcome in BED [21] and short-term hospital treatment outcome in underweight eating disorder patients [18]. There is thus a need to develop attractive treatment interventions that can enhance patients' self-efficacy, insight and strengthen collaboration with clinicians and significant others[13, 22-24]. An engaging serious digital game that can augment treatment may be a way forward to improve patients self-perceived ability to create change and insight. Serious Games (SGs) are defined as "digital games created not with the primary purpose of pure entertainment, but with the intention of serious use as in training, education and health care." [25]. SGs are establishing a greater evidence-base in both somatic and mental health care [24, 26-29], probably due to their around-the-clock availability, their potential to motivate, and their ability to engage users in a challenging problem while exploring new solutions without experiencing real-life risks. A SG has the potential to become an intervention that patients can play with to help them meet and cope with the challenges of EDs. So far, serious video games (SVG) and virtual reality (VR) have been the most studied digital interventions in EDs. These have been used as therapeutic adjuncts and show promise [30, 31]. SGs that can be played on a smartphone and thus are easily available, have not been seen until now. Neither has SGs developed together with patients themselves been seen. To our knowledge only one study so far has used experience-based co-design to develop a cognitive behavioural therapy-based intervention for people with type 1 diabetes and disordered eating [32].To our knowledge the only SG produced with ED patients and clinicians, is Maze Out [24].

Aims The aims of the present project are twofold: to evaluate the effectiveness of Maze Out when added to treatment of ED patients receiving TAU (study 1); and to explore the experience and use of Maze Out (study 2).

Description of the cohort

Participants will be recruited from a broad set of treatment institutions, offering treatment and care to patients diagnosed with ED. The treatment institutions include psychiatric centres within the mental health care services, psychiatric clinics, municipal ED teams, mental health care institutions, and endocrinology services specialised in EDs, all situated in Denmark. All regions in Denmark will be invited to participate. Recruitment from a wide range of treatment institutions and locations is intended to reflect everyday practice and nuances in clinical approach to EDs in Denmark. To be eligible to participate, patients must: 1) agree to participate in the study and sign written informed consent; 2) be aged 18 or above; 3) speak Danish; 4) have a registered ED diagnosis according to ICD-10 (i.e., not only ED symptoms) and 5) receiving support or treatment for ED. The ability to speak Danish is necessary Maze Out so far only exists in Danish.

Data and biological material

questionnaire data and data from the patient journal.

Publications associated with the project

Guala, M. M., Bul, K., Skårderud, F., & Søgaard Nielsen, A. (2023). A Serious Game for Patients With Eating Disorders (Maze Out): Pilot User Experience and Acceptance Study. JMIR Formative Research, 7, e40594.