"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.

Improvement in quality of life among women and men aged 60 years and older following treatment for alcohol use disorder.

BACKGROUND: Previous studies have yielded mixed results on the association between gender and alcohol use disorder (AUD) treatment outcomes. Thus, additional research is needed to determine the effect of gender on AUD treatment outcomes, including quality of life (QoL), particularly among older adults. AIMS: In a clinical sample of older adults with DSM-5 AUD, we examined changes in QoL from the beginning of AUD treatment through 1 year of follow-ups. We also examined the effect of gender and explored interaction effects with gender on QoL. METHODS: We utilized data from the "Elderly Study," a multi-national, single-blind, randomized, controlled trial of 693 adults aged 60+ with DSM-5 AUD. Alcohol use was assessed with the Form-90, and QoL with the brief version of the World Health Organization QoL measure. Information was collected at treatment initiation and at 4-, 12-, 26-, and 52-week follow-ups. Multilevel mixed-effects logistic and linear regression models were used to examine QoL changes and the effect of gender on changes in QoL. RESULTS: Following treatment, small, but significant improvements were seen over time in overall perceived health (p < 0.05). Improvements that persisted over the 1-year follow-up period were seen in the QoL domains of physical health (ß: 2.6, 95% CI: 1.4-3.9), psychological health (ß: 3.5, 95% CI: 3.3-3.8), social relationships (ß: 4.0, 95% CI: 2.5-5.6), and environmental health (ß: 1.4, 95% CI: 0.4-2.4). No significant changes were seen over time in overall perceived QoL (p = 0.58). Gender was not associated with changes in any of the QoL outcome measures (all p ≥ 0.05). CONCLUSIONS: Among 60+ year-old adults receiving treatment for DSM-5 AUD, improvements in QoL were achievable and maintained over time, but were not associated with gender.

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.

The Danish RESPEKT Campaign: Impact of a National Mass Media Campaign Aiming to Increase Treatment Seeking for Alcohol Use Disorders.

Background: A minority of all with alcohol use disorders seek treatment. In Denmark, a media campaign, "RESPEKT," has been broadcast nationwide since 2015. The campaign is unique from an international perspective and aims to increase treatment-seeking. Similar interventions have, up until now, not been scientifically evaluated.Aim: To investigate campaign awareness, understanding, attitudes, and information-seeking pre- and post the campaign period. Also, associations to demographic factors and year of campaign will be investigated.Method: Study design: Repeated cross-sectional studyParticipants: Adults aged 30-70 years, in total n = 9169.Data: Pre- and post the campaign period between 2017 and 2020, an online questionnaire was administered by a market research company. The questionnaire covered demographic data, campaign awareness, understanding, attitudes, and information-seeking about treatment for alcohol use disorders. In addition, complete-case logistic regression was performed to model dichotomous outcomes, and odds ratios were calculated.Results: Campaign awareness varied between 8 and 40% over the different years. Understanding of the main message was high and received higher endorsements over the study period. A majority expressed positive attitudes toward the campaign and support for the main message regarding free treatment. However, very few self-reported seeking information about AUD treatment. Female sex was associated with higher awareness of the campaign, higher understanding and more positive attitudes toward the campaign.Conclusion: The campaign evoked positive attitudes and had an impact on increasing knowledge and changing attitudes. However, no effect on self-reported information seeking about treatment was found.

Personality traits and alcohol consumption: Secondary analysis of the Self-Match Study.

BACKGROUND: This secondary analysis of the Self-Match Study explores whether personality traits affect the treatment outcome for alcohol use disorders (AUD). We designed the Self-Match Study to investigate whether clients choosing between treatment options improves treatment outcomes. The primary outcome report revealed no difference in the outcome, whether treatment allocation was based on clinician matching or self-matching. Because willingness to choose, choice of treatment method, and compliance with treatment may be related to personality, this exploratory sub-study investigated the influence of personality traits on treatment outcome. METHOD: We enrolled 402 consecutive clients (female 46.7%, mean age 47.4) seeking treatment at the outpatient alcohol treatment center in Odense, Denmark. Clients were randomized to treatment by expert-match or self-matching. Data on alcohol consumption (Timeline Follow Back), personality traits (NEO-FFI-3), and retention in care were collected at baseline and 6-month follow-up. Outcomes were compliance, sensible drinking (alcohol intake below National Recommendations), and the number of heavy drinking days at follow-up. RESULTS: A high neuroticism score was negatively associated with treatment completion. Further, clients with a high score on neuroticism, openness, and extraversion, or a low score on conscientiousness were less likely to reduce their drinking to a sensible level at follow-up. We also found that low scores on conscientiousness were associated with having more heavy drinking days at follow-up. The personality traits neuroticism and openness were associated with treatment preferences. CONCLUSIONS: Personality traits influence 6 months drinking outcomes for people receiving AUD treatment.

Differences in the delivery of motivational interviewing across three countries.

We do not know if the delivery of Motivational Interviewing (MI) differs across countries. In an international study targeting Elderly people with Alcohol Use Disorder, The Elderly Study, MI was part of the treatment applied. Treatment delivery was measured by means of the Motivational Interviewing Treatment Integrity code version 4 (MITI 4). Mixed effects models explored potential differences in delivery of MI between the countries. Delivery of MI differed significantly between participating countries: Denmark, Germany and the US. These findings are important to consider when comparing measures of MI integrity across studies from different cultures.

Residual alcohol use disorder symptoms after treatment predict long-term drinking outcomes in seniors with DSM-5 alcohol use disorder.

BACKGROUND: Risk of relapse within the first months after alcohol use disorder (AUD) interventions is substantial among older adults. For this vulnerable group, little information exists on how this risk is associated with residual DSM-5 AUD symptoms after treatment. AIMS: To investigate among older adults who received short-term treatment for DSM-5 AUD (1) the prediction of drinking behaviors and quality of life 12 months after treatment initiation by 6-month DSM-5 AUD symptoms, AUD severity, and AUD remission, and (2) whether these DSM-5 AUD indicators provide prognostic information beyond that gained from 6-month alcohol use (AU) status. METHODS: The international multicenter RCT "ELDERLY-Study" enrolled adults aged 60+ with DSM-5 AUD. We used data from the subsample of 323 German and Danish participants with complete DSM-5 AUD criterion information 6 months after treatment initiation (61% male; mean age = 65.5 years). AU was assessed with Form 90, DSM-5 AUD with the M.I.N.I., and quality of life with the WHOQOL-BREF. Generalized linear models were applied to investigate the associations between 6-month AUD indicators and 12-month AU and quality of life. RESULTS: Independent of AU at 6 months, having 1 (vs. no) residual AUD symptom at 6 months predicted a 12-month "slip," defined as exceeding a blood alcohol concentration of 0.05% at least once during that time (OR: 3.7, 95% CI: 1.5 to 9.0), heavy episodic drinking, and hazardous use (p < 0.05). AUD remission was associated with a lower risk of a "slip" at 12 months (p < 0.05). Failed reduction/cessation was associated with poorer physical health (Coef.: -0.4, 95% CI -0.7 to -0.1). CONCLUSION: For older adults, residual AUD symptoms in the first months after short-term treatment predict problematic AU outcomes during the first 12 months after treatment entry. Thus, residual symptoms should be addressed in this patient population during posttreatment screenings.

Distinct health-related risk profiles among middle-aged and older adults with risky alcohol use from the Danish general population.

BACKGROUND: Knowledge is lacking on distinct health-related risk profiles among the substantial group of middle-aged and older adults with risky alcohol use (AU). Such profiles could inform the planning of interventions and prevention. AIMS: To 1) identify distinct health-related profiles based on different types of health-related functioning limitations and distress and 2) assess associations between these profiles and age, sex, and health-relevant behaviors (e.g., smoking). METHODS: Cross-sectional nation-wide Danish health survey with n = 6630 adults aged 55-64 and n = 7605 aged 65-74 with at least risky AU (>84 g ethanol/week in women, >168 in men). Health-related risk profiles were identified with Latent Class Analysis (LCA). Multinomial regression was applied for the association between risk profiles and auxiliary variables. RESULTS: A six-class LCA solution was found among 55-64 year-olds (classes: 'Normative' [61%], 'Distress' [6%], 'Mental health limitations [5%]', 'Pain-related distress [10%]', 'Broad limitations and pain distress [7%]', 'High overall burden' [11%]) and a five-class solution among 65-74 year-olds. Most classes were comparable across age groups. The 'Distress'-class characterized by pain-distress, tiredness-distress, and sleep-related distress (6%) only showed in the younger group. In both age groups, auxiliary covariates (high-risk AU, possible alcohol use disorder, weekly smoking) were positively associated with problematic profile membership (vs. normative class membership). CONCLUSION: Middle-aged and older adults with risky AU have distinct health-related profiles relevant for the form and content of prevention and interventions. Despite their distinct features, almost all problematic health profiles warrant careful attention regarding high-risk AU and probable alcohol use disorder.

Consistency between self-reported alcohol consumption and biological markers among patients with alcohol use disorder - A systematic review.

BACKGROUND: No systematic review has yet examined the consistency between self-reports of alcohol consumption and alcohol biomarkers among patients in treatment for alcohol use disorders (AUD). Therefore, we aimed to provide an overview of the consistency between self-reported alcohol intake and biomarkers among patients in treatment for AUD. METHODS: The electronical databases MEDLINE, PsycINFO, EMBASE, Cochrane Database of Systematic Reviews (CDSR) and CENTRAL were searched for all original studies that examined the validity of self-reported alcohol consumption using a biological marker in samples of patients with AUD. Eligible studies were included in a qualitative synthesis of the outcomes. Quality assessment was conducted with the quality assessment tool for Observational Cohort and Cross-sectional studies, developed by The National Heart, Lung and Blood Institute. RESULTS: The search identified 7672 hits, and 11 papers comprising 13 eligible studies were included. All the identified studies revealed inconsistencies between self-reporting and biomarkers. Under-reporting was the most common type of inconsistency across short-, intermediate- and long-term biomarkers. For short-term markers, under-reporting was indicated in 7 studies (n = 15-585) in a range from 5.5%-56.0% of the patients, and over-reporting in 2 studies (n = 34-65) in a range from 5.9%-74.1%. Only under-reporting was reported for intermediate-term, direct markers and was indicated in 2 studies (n = 18-54) in a range from 5.0%-50.0% of the patients. Although the results for long-term biomarkers were not reported consistently across the studies, under-reporting was indicated in 3 studies (n = 73-1580) in a range from 0.1%-40.0% of the patients, and over-reporting in 2 studies (n = 15-1580) in a range from 13.0%-70.6%. Correlations between self-reported alcohol consumption and biological markers were strongest for the intermediate-term direct markers, ranging from moderate to strong. For short-term and long-term markers, the correlations were mostly weak. Most of the studies were quality rated as fair. CONCLUSION: The findings indicate that inconsistency between self-reported alcohol consumption and biomarkers may occur in a considerable proportion of patients with AUD. However, further studies applying more sensitive, specific, and easily assessable biological markers are warranted to confirm this preliminary synthesis. PROSPERO registration no.: CRD42018105308.

Stability of Posttreatment Reductions in World Health Organization (WHO) Drinking Risk Levels and Posttreatment Functioning in Older Adults with DSM-5 Alcohol Use Disorder: Secondary Data Analysis of the Elderly Study.

BACKGROUND: Studies have found that reductions in World Health Organization (WHO) drinking risk levels may be a stable outcome of treatment for alcohol use disorder (AUD) and associated with functional improvements. The aim of this study was to investigate whether posttreatment reductions in WHO drinking risk levels are stable over time among older adults and associated with a decrease in consequences of drinking and AUD symptoms and improved quality of life. METHODS: Participants. Individuals 60+ years old, suffering from DSM-5 AUD (n = 693), and seeking outpatient treatment. MEASUREMENTS: WHO drinking risk levels, prior to treatment and at all follow-up points up to 1 year after treatment start, were assessed with Form 90. Outcomes at follow-up included consequences of drinking (Drinker Inventory of Consequences), quality of life (WHOQOL-BREF), and DSM-5 AUD symptoms (Mini International Neuropsychiatric Interview). Logistic regression and linear mixed models were used to examine the probability of maintaining risk-level reductions at follow-up and the association between risk-level reductions and outcomes, respectively. RESULTS: Reductions in risk levels were maintained over time (at least 1 level: OR 5.39, 95% CI 3.43, 8.47; at least 2 levels: OR 9.30, 95% CI 6.14, 14.07). Reductions were associated with reduced consequences of drinking and number of AUD symptoms, and minor, but statistically significant, improvements in quality of life. CONCLUSIONS: Maintaining reductions in WHO risk levels appears achievable for older adults seeking treatment for AUD. The small reduction of AUD symptoms and improvement of quality of life indicates that these reductions may not be adequate as the only treatment goal.

The effect of exercise as adjunctive treatment on quality of life for individuals with alcohol use disorders: a randomized controlled trial.

BACKGROUND: A physically active lifestyle contributes to the prevention of lifestyle diseases, promotion of physical health, and reduction of pain, among other benefits. Being physically active also promotes mental health for many individuals, in the form of improved mood, increased self-efficacy and reduced risk of depression. Alcohol-dependent individuals may experience a better quality of life when supplementing their treatment with physical exercise. This study aimed to evaluate the effect of exercise on Quality of Life among patients with alcohol use disorder in a large randomized controlled trial. METHODS: The study had three arms: Patients were allocated to (A) treatment as usual, (B) treatment as usual and supervised group exercise two days a week of one hour each, (C) treatment as usual and individual physical exercise minimum two days a week. Duration of the intervention was six months. Data on values of Quality of Life were collected at baseline (before treatment start and at time of enrollment in the study), and at follow-up (at six months after enrollment in the study) using the EQ-5D questionnaire and the EQ-VAS. The sample consisted of 117 consecutive patients, and the follow-up rate was 66.6%. Intention-to-treat analyses were conducted to evaluate the effect of exercise on quality of life. RESULTS: Although not statistically significant, a substantial portion of the participants in the individual exercise condition reported that they had no pain or discomfort (one of the five quality of life dimensions measured by EQ-5D questionnaire) compared to the controls at follow-up. No difference was found between the groups regarding the EQ-VAS. CONCLUSION: The exercise intervention had no effect on quality of life for patients with alcohol use disorder, nor was quality of life improved across the total sample. More research in how to improve quality of life for patients with alcohol use disorder is needed. TRIAL REGISTRATION: ISRCTN74889852 (retrospectively registered, date: 16/05/2013).

Making a bridge between general hospital and specialised community-based treatment for alcohol use disorder-A pragmatic randomised controlled trial.

AIM: To investigate if more patients in the intervention group attended specialized alcohol treatment compared with a treatment-as-usual group (TAU). METHODS: Pragmatic randomized controlled trial where consecutive patients, admitted to somatic hospitals, filled out a lifestyle questionnaire with the Alcohol Use Disorder Identification Test (AUDIT) embedded. Patients scoring 8+ on AUDIT were included in the study. Included patients were randomized to either a Danish screening brief intervention and referral to treatment (SBIRT) called the Relay model or TAU depending on date of admission. The Relay group was offered a brief alcohol intervention by an outreach alcohol therapist. Patients scoring 16 points and above on the AUDIT test also received referral to alcohol treatment. Outcome was attendance at specialized outpatient alcohol treatment centres after discharge from hospital. Information on patients was gathered from municipal databases at 18 months follow-up. RESULTS: A total of 3534 patients completed the questionnaire, and 609 patients (17%) scored AUDIT 8+. 48 patients were lost to follow-up, and the final sample had 561 patients. Only 33 patients (6%) attended outpatient treatment at 18-months follow-up, but significantly more patients in the Relay group sought alcohol treatment than in the TAU group (OR = 2.5 [1.2;5.2] (p = 0.017)). Number needed to treat (NNT) was 20 [95% CI 11.2;112.3]. CONCLUSION: The Relay intervention was associated with more patients attending specialized treatment, but further research is needed to establish if general hospitals are an excellent platform for performing SBIRT.

Comorbid social phobia does not predict the outcome in alcohol use disorder outpatient treatment.

BACKGROUND: Social phobia (SP) is one of the most prevalent anxiety disorders among patients entering treatment for alcohol use disorders (AUD). However, few studies have examined the association between SP and alcohol-related treatment outcomes in naturalistic settings. AIMS: The aims of this study were to estimate the prevalence of co-morbid SP and to investigate the impact of the co-morbidity on the treatment course, dropout rates and treatment outcomes in a large sample of AUD patients treated in an outpatient alcohol treatment clinic. METHODS: The study was conducted as an observational cohort study. A consecutive sample of 3.197 treatment-seeking outpatients, with an AUD diagnosis according to the ICD-10 Diagnostic Criteria for Research, was assessed by means of the Addiction Severity Index at treatment start and at treatment conclusion. RESULTS: Approximately 15% of the patients suffered from SP when entering treatment and patients with and without SP did not differ on the treatment course, compliance or dropout rates. SP did not predict any alcohol-related treatment outcomes either, where no association was found on change scores for abstinence, drinking days and days with excessive drinking relative to AUD patients without co-morbidity. CONCLUSION: AUD patients with and without co-morbid SP were equally likely to achieve benefits when treated similarly with evidence-based pharmacological and psychosocial approaches in a naturalistic setting.

Exercise as adjunctive treatment for alcohol use disorder: A randomized controlled trial.

AIMS: To examine whether physical activity as an adjunct to outpatient alcohol treatment has an effect on alcohol consumption following participation in an exercise intervention of six months' duration, and at 12 months after treatment initiation. METHODS: The study is a randomized controlled study with three arms: Patients allocated to (A) treatment as usual, (B) treatment as usual and supervised group exercise, (C) treatment as usual and individual physical exercise. The primary outcome measure was excessive drinking six months after treatment start and completion of the intervention. A logistic regression model was used to evaluate the odds of excessive drinking among the three groups, based on intention-to-treat. Changes in level of physical activity in all three groups were tested by using a generalized linear mixed model. A multiple linear model was used to test if there was an association between amount of performed physical activity and alcohol consumption. RESULTS: A total of 175 patients (68.6% male) participated. Response rates were 77.7% at six months and 57.1% at 12 months follow-up. OR 0.99 [95% CI: 0.46; 2.14], p = 0.976 for excessive drinking in the group exercise condition, and 1.02 [95% CI: 0.47; 2.18], p = 0.968 in the individual exercise condition, which, when compared to the control group as reference, did not differ statistically significantly. Participants with moderate level physical activity had lower odds for excessive drinking OR = 0.12 [0.05; 0.31], p<0.001 than participants with low level physical activity. Amount of alcohol consumption in the intervention groups decreased by 4% [95% CI: 0.03; 6.8], p = 0.015 for each increased exercising day. CONCLUSIONS: No direct effect of physical exercise on drinking outcome was found. Moderate level physical activity was protective against excessive drinking following treatment. A dose-response effect of exercise on drinking outcome supports the need for implementing physically active lifestyles for patients in treatment for alcohol use disorder.

The RESCueH Programme: Testing New Non-Pharmacologic Interventions for Alcohol Use Disorders: Rationale and Methods.

Excessive alcohol consumption is one of the most important lifestyle factors affecting the disease burden in the Western world. The results of treatment in daily practice are modest at best. The aim of the RESCueH programme is to develop and evaluate methods, which are as practice-near as possible, and therefore can be implemented quickly and easily in everyday clinical practice. It is the first clinical alcohol programme to be transatlantic in scope, with implementation in treatment centers located in Denmark, Germany and the US. The RESCueH programme comprises 5 randomized controlled trials, and the studies can be expected to result in (1) more patients starting treatment in specialized outpatient clinics, (2) a greater number of elderly patients being treated, (3) increased patient motivation for treatment and thus improved adherence, (4) more patients with stable positive outcomes after treatment and (5) fewer patients relapsing into harmful drinking. The aim of this paper is to discuss the rationale for the RESCueH programme, to present the studies and expected results.

Influence of pretreatment coping strategies on the outcome of outpatient treatment of Danish alcohol abusers.

An important issue regarding treatment for alcohol abuse is the high rate of relapse following treatment. In the research on treatment of alcohol abuse, the concept of coping has been proposed as a relevant factor in the relationship between relapse crises and treatment outcome. The present study investigated the role of pretreatment coping strategies in outcome of outpatient treatment for alcohol abuse. The pretreatment coping strategies of 136 clients receiving outpatient treatment for alcohol abuse were examined as a predictor of drinking pattern after treatment. The pretreatment coping strategies were assessed by the COPE questionnaire. Drinking pattern after treatment was assessed at follow-up one year after treatment was entered. Results indicated that some pretreatment coping strategies are identifiable as adaptive and maladaptive coping strategies, respectively, regarding successful treatment for alcohol abuse. Restraint coping was found predictive of a positive drinking pattern at follow-up while the use of alcohol to cope was found predictive of a negative drinking pattern. Furthermore, the results showed tendencies towards the possibility that some coping strategies co-operated differently with types of treatment methods.