"Maze Out": a study protocol for a randomised controlled trial using a mix methods approach exploring the potential and examining the effectiveness of a serious game in the treatment of eating disorders.

BACKGROUND: Eating Disorders (ED) are severe and costly mental health disorders. The effects of existing treatment approaches are limited and there is a need to develop novel interventions, including digital strategies that can increase engagement and effectiveness. Maze Out is a new serious game coproduced by patients and ED therapists, which allows patients to "play" with the reality of an ED and reflect on associated challenges. OBJECTIVES: The present study has two main objectives: (1) to evaluate the effectiveness of adding Maze Out to treatment as usual (TAU) in a randomised controlled trial (RCT); and (2) to examine in depth the potential of Maze Out by examining how it is perceived and used in the context of an RCT. METHODS: Participants will be recruited from mental health care services, endocrinology departments or Community Centres offering treatment for ED. Patients suffering from ED (N = 94) will be randomised to either TAU or TAU plus Maze Out. Primary outcome will be measured in terms of changes in self-efficacy, measured by a 5-item self-efficacy questionnaire (5-item SE_ED). Secondary outcome measures will include feelings of ineffectiveness and self-image, as measured by Eating Disorder Inventory, version 3 (EDI-3), Brief INSPIRE-O and Structural Analysis of Social Behaviour Intrex Questionnaire (SAS-B). Data will be collected at baseline (enrolment in the study), and subsequently 8 and 15 weeks after inclusion. Experiences of playing Maze Out will be examined in a sub-sample of participants, utilising both quantitative user analytics and qualitative interview data of patients, interview data of significant others, and healthcare professionals to explore the possible impact of Maze Out on disorder insight, communication patterns between patients and therapists and understanding of their disorder. DISCUSSION: To our knowledge Maze Out is the first serious game coproduced by patients and therapists. It is a novel and theoretically grounded intervention that may significantly contribute to the healing process of ED. If found effective, the potential for wide-spread impact and scalability is considerable. Trial registration ClinicalTrials.gov NCT05621018.

A Serious Game for Patients With Eating Disorders (Maze Out): Pilot User Experience and Acceptance Study.

BACKGROUND: Eating disorders (EDs) are severe mental disorders associated with notable impairments in the quality of life. Despite the severity of the disorders and extensive research in the field, effective treatment for EDs is lacking. Digital interventions are gaining an evidence-based position in mental health, providing new perspectives in psychiatric treatment. Maze Out is a serious game coproduced by patients and therapists that focuses on supporting patients with EDs. OBJECTIVE: The aim of this study was to investigate the experiences of engaging in and acceptability of Maze Out among patients with EDs and therapists. METHODS: This study is a qualitative pilot study involving data collected through focus groups and individual interviews and user analytics collected through the game. The participants were recruited from the Odense Mental Health Service of the Region of Southern Denmark. Qualitative interviews analyzed by thematical analysis and interpreted by interpretative phenomenological analysis were used to evaluate the acceptance and experience of Maze Out among patients and therapists. The mobile health evidence reporting and assessment checklist was used to describe the content, context, and technical features of the game in a standardized manner for mobile health apps. RESULTS: The participants found Maze Out to be engaging, easy to use, and a good platform for reflecting on their disorder. They primarily used Maze Out as a conversational tool with their close relationships, giving them insights into the experiences and daily life struggles of someone with EDs. CONCLUSIONS: Maze Out seems to be a promising tool supplementing the current ED treatment. Further research should focus on evaluating the effectiveness of the game and its potential to support patients with different types of EDs.

Eating disorders and subsequent risk of substance use disorders involving illicit drugs: a Danish nationwide register-based cohort study.

PURPOSE: No study has investigated the ongoing risk of substance use disorders involving illicit drugs (ISUD) after first eating disorder (ED) and whether the pattern of risk differs according to types of ED and ISUD. Therefore, we aimed to longitudinally assess the risk of a subsequent diagnosis of any ISUD (pooled category) and specific ISUD after a first-time diagnosis of anorexia nervosa (AN), bulimia nervosa (BN), or unspecified ED (USED). METHODS: A retrospective cohort study using data from Danish nationwide registers identified 20,759 ED patients and 83,038 matched controls (1:4 ratio). Risk of any ISUD diagnosis after first ED diagnosis was estimated by generating hazard ratios (HR). Logistic regression was applied to assess associations between each ED and specific ISUD. RESULTS: Patients with AN, BN, and USED (without a prior ISUD diagnosis) exhibited an increased relative risk of a subsequent diagnosis of any ISUD compared with respective controls, and the elevated risk persisted over 10 years (AN, adjusted HRs ranging from 1.60 [99% CI 1.15-2.24] to 5.16 [3.14-8.47]; BN, 2.35 [1.46-3.79] to 14.24 [6.88-29.47]; USED, 2.86 [1.35-3.79] to 8.56 [3.31-29.47]). The highest estimates were observed during the first year of follow-up. Each ED type was associated with an increased likelihood of all types of ISUD. AN and USED were most strongly associated with sedatives/hypnotics, BN with other illegal substances (e.g., ecstasy and hallucinogens). CONCLUSIONS: ED patients have a considerable risk for subsequent ISUD. Prevention efforts and treatment targeting ISUD are likely required to improve ED treatment prognosis.

The Impact of Alcohol and Other Substance Use Disorders on Mortality in Patients With Eating Disorders: A Nationwide Register-Based Retrospective Cohort Study.

OBJECTIVE: Research is lacking on the contribution of different types of substance use disorders (SUDs) to excess mortality across the full spectrum of eating disorders. The authors assessed the association of alcohol use disorders and other SUDs with mortality in anorexia nervosa, bulimia nervosa, and unspecified eating disorder compared with matched control subjects. METHODS: A retrospective cohort study was conducted using Danish nationwide registers. The study included 20,759 patients with eating disorders and 83,036 matched control subjects. Hazard ratios were calculated to compare all-cause mortality risk between eating disorder patients and control subjects both with and without a lifetime SUD diagnosis (abuse or dependence of alcohol, cannabis, or hard drugs). RESULTS: For patients with each type of eating disorder, a higher risk of all-cause mortality was observed relative to control subjects without SUDs among those who abused alcohol and/or cannabis (adjusted hazard ratios for the anorexia nervosa, bulimia nervosa, and unspecified eating disorder patients, respectively, were 11.28 [95% CI=7.01, 18.16], 5.86 [95% CI=3.37, 10.1], and 10.86 [95% CI=6.74, 17.50]), or hard drugs alone or in combination with alcohol and/or cannabis (adjusted hazard ratios, respectively, were 22.34 [95% CI=15.13, 33.00], 11.43 [95% CI=7.14, 18.28], and 15.53 [95% CI=10.15, 23.78]), than in those without SUDs (adjusted hazard ratios, respectively, were 3.21 [95% CI=2.43, 4.23], 1.24 [95% CI=0.88, 1.77], and 4.75 [95% CI=3.57, 6.31]). Control subjects with SUDs also exhibited an elevated risk of all-cause mortality relative to control subjects without SUDs, although to a much lesser extent than eating disorder patients with SUDs. CONCLUSIONS: SUDs have an additive effect on excess mortality in patients with eating disorders. The prevention and treatment of SUDs in this patient group is thus imperative to reduce mortality.

Does receiving an eating disorder diagnosis increase the risk of a subsequent alcohol use disorder? A Danish nationwide register-based cohort study.

BACKGROUND AND AIM: No large-scale, longitudinal clinical study has examined whether patients with different types of eating disorders (ED) have an increased risk of a subsequent alcohol use disorder (AUD). This study aimed to assess the ongoing risk of receiving a diagnosis of AUD following a first-time diagnosis of anorexia nervosa (AN), bulimia nervosa (BN), or unspecified ED (USED). DESIGN: Retrospective cohort study. SETTING: Danish nationwide registries, January 1994 to December 2018. PARTICIPANTS: A total of 20 759 ED patients and 83 036 controls were followed from the date of first ED diagnosis (index date) until the date of first AUD diagnosis, death, emigration, or the end of the study. Controls were selected in a 1:4 ratio and matched on month and year of birth, gender and ethnicity. MEASUREMENTS: We obtained data on ED (AN, BN, USED; exposure) and AUD (abuse/dependence; outcome) diagnoses as well as sociodemographics and other psychiatric diagnoses. Time to AUD was generated from the index date. Risk of AUD after the index date was assessed among those without a prior AUD diagnosis while adjusting for sociodemographics and prior psychiatric diagnoses. FINDINGS: Compared with controls, an increased relative risk of AUD after the index date was observed in AN patients throughout the study lasting 15 + years (adjusted hazard ratios [HRs] ranging from 2.49 [99% CI = 1.46, 4.25] to 6.83 [2.84, 16.41]), in BN patients during the first year of follow-up and from 2 years onward (2.72 [1.66, 4.44] to 17.44 [6.01, 50.63]), and in USED patients during the first year and 2-15 years of follow-up (2.52 [1.54, 4.14] to 14.17 [5.86, 34.27]). In all three groups, estimates were highest during the first year, particularly among BN patients. CONCLUSIONS: Patients with anorexia nervosa, bulimia nervosa, or unspecified eating disorders appear to have an increased ongoing risk of receiving a diagnosis of alcohol use disorder following their first eating disorder diagnosis compared with controls.

The Impact of Alcohol and Other Substance Use Disorders on Mortality in Patients With Eating Disorders: A Nationwide Register-Based Retrospective Cohort Study.

OBJECTIVE: Research is lacking on the contribution of different types of substance use disorders (SUDs) to excess mortality across the full spectrum of eating disorders. The authors assessed the association of alcohol use disorders and other SUDs with mortality in anorexia nervosa, bulimia nervosa, and unspecified eating disorder compared with matched control subjects. METHODS: A retrospective cohort study was conducted using Danish nationwide registers. The study included 20,759 patients with eating disorders and 83,036 matched control subjects. Hazard ratios were calculated to compare all-cause mortality risk between eating disorder patients and control subjects both with and without a lifetime SUD diagnosis (abuse or dependence of alcohol, cannabis, or hard drugs). RESULTS: For patients with each type of eating disorder, a higher risk of all-cause mortality was observed relative to control subjects without SUDs among those who abused alcohol and/or cannabis (adjusted hazard ratios for the anorexia nervosa, bulimia nervosa, and unspecified eating disorder patients, respectively, were 11.28 [95% CI=7.01, 18.16], 5.86 [95% CI=3.37, 10.1], and 10.86 [95% CI=6.74, 17.50]), or hard drugs alone or in combination with alcohol and/or cannabis (adjusted hazard ratios, respectively, were 22.34 [95% CI=15.13, 33.00], 11.43 [95% CI=7.14, 18.28], and 15.53 [95% CI=10.15, 23.78]), than in those without SUDs (adjusted hazard ratios, respectively, were 3.21 [95% CI=2.43, 4.23], 1.24 [95% CI=0.88, 1.77], and 4.75 [95% CI=3.57, 6.31]). Control subjects with SUDs also exhibited an elevated risk of all-cause mortality relative to control subjects without SUDs, although to a much lesser extent than eating disorder patients with SUDs. CONCLUSIONS: SUDs have an additive effect on excess mortality in patients with eating disorders. The prevention and treatment of SUDs in this patient group is thus imperative to reduce mortality.