Background: Eating disorders are serious conditions associated with an impaired health-related quality of life and increased healthcare utilization and costs. Despite the existence of evidence-based treatments, access to treatment is often delayed due to insufficient health care resources. Internet-based self-help interventions may have the potential to successfully bridge waiting time for face-to-face outpatient treatment and, thus, contribute to overcoming treatment gaps. However, little is known about the feasibility of implementing such interventions into routine healthcare. The aim of this study is to analyze the effects and feasibility of an Internet-based selfhelp intervention (everyBody Plus) specifically designed for patients with Bulimia Nervosa, Binge Eating Disorder and other specified feeding and eating disorders (OSFED) on a waiting list for outpatient face-to-face treatment. The aim of this paper is to describe the study protocol. Methods: A multi-country randomized controlled trial will be conducted in Germany and the UK. N=275 female patients awaiting outpatient treatment will be randomly allocated either to the guided online self-help intervention “everyBody Plus” or a waitlist control group condition without access to the intervention. everyBody Plus comprises eight weekly sessions that cover topics related to eating and exercise patterns, coping with negative emotions and stress as well as improving body image. Participants will receive weekly individualized feedback based on their self-monitoring and journal entries. Assessments will take place at baseline, post-intervention as well as at 6- and 12-months follow up. In addition, all participants will be asked to monitor core eating disorder symptoms weekly to provide data on the primary outcome. The primary outcome will be number of weeks after randomization until a patient achieves a clinically relevant improvement in core symptoms (BMI, binge eating, compensatory behaviors) for the first time. Secondary outcomes include frequency of core symptoms and eating disorder related attitudes and behaviors, as well as associated psychopathology. Additional secondary outcomes will be the participating therapists' confidence in treating eating disorders as well as perceived benefits of everyBody Plus for patients. Discussion: To the best of our knowledge, this is the first randomized controlled trial examining the effects of Internet-based self-help for outpatients with eating disorders awaiting face-to-face outpatient treatment. If proven to be effective and successfully implemented, Internet-based self-help programs might be used as a first step of treatment within a stepped-care approach, thus reducing burden and cost for both patients and health care providers.

Background: Depression is one of the most frequent and costly mental disorders. While there is increasing evidence for the efficacy of online self-help to improve depression or prevent relapse, there is little evidence in blended care settings, especially combined with inpatient face-to-face psychotherapy. Therefore, we evaluated whether an evidencebased online self-help program improves the efficacy of inpatient psychotherapy. Methods: A total of 229 depressed patients were randomly allocated either to an online selfhelp program (intervention group [IG]; Deprexis) or an active control group (CG; weekly online information on depression) in addition to inpatient psychodynamic psychotherapy. Both groups had access to their respective experimental intervention for 12 weeks, regardless of inpatient treatment duration. Reduction of depressive symptoms, as measured with the Beck Depression Inventory-II, was the primary outcome at the end of the intervention (T2). Results: Depressive symptoms were statistically significantly lower in the IG compared to the active CG at T2 with a moderate betweengroup effect size of d = 0.44. The same applied to anxiety ( d = 0.33), quality of life ( d = 0.34), and self-esteem ( d = 0.38) at discharge from inpatient treatment (T1). No statistically significant differences were found regarding dysfunctional attitudes ( d = 0.14) and work ability ( d = 0.08) at T1. Conclusions: This is the first evidence for blended treatment combining online self-help with inpatient psychotherapy. The study opens new and promising avenues for increasing the efficacy of inpatient psychotherapy. Future studies should determine how integration of online self-help into the therapeutic process can be developed further.

Background: Controversy surrounds the questions whether co-occurring depression has negative effects on cognitivebehavioral therapy (CBT) outcomes in patients with panic disorder (PD) and agoraphobia (AG) and whether treatment for PD and AG (PD/AG) also reduces depressive symptomatology. Methods: Post-hoc analyses of randomized clinical trial data of 369 outpatients with primary PD/AG (DSM-IV-TR criteria) treated with a 12-session manualized CBT (n = 301) and a waitlist control group (n = 68). Patients with comorbid depression (DSM-IV-TR major depression, dysthymia, or both: 43.2% CBT, 42.7% controls) were compared to patients without depression regarding anxiety and depression outcomes (Clinical Global Impression Scale [CGI], Hamilton Anxiety Rating Scale [HAM-A], number of panic attacks, Mobility Inventory [MI], Panic and Agoraphobia Scale, Beck Depression Inventory) at post-treatment and follow-up (categorical). Further, the role of severity of depressive symptoms on anxiety/depression outcome measures was examined (dimensional). Results: Comorbid depression did not have a significant overall effect on anxiety outcomes at post-treatment and follow-up, except for slightly diminished post-treatment effect sizes for clinician-rated CGI (p = 0.03) and HAM-A (p = 0.008) when adjusting for baseline anxiety severity. In the dimensional model, higher baseline depression scores were associated with lower effect sizes at post-treatment (except for MI), but not at follow-up (except for HAM-A). Depressive symptoms improved irrespective of the presence of depression. Conclusions: Exposure-based CBT for primary PD/AG effectively reduces anxiety and depressive symptoms, irrespective of comorbid depression or depressive symptomatology. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

Background: Evidence-based treatment algorithms, successfully established for asthma, are missing for atopic eczema (AE). Objectives: To investigate whether treatment according to an evidence-based algorithm is an effective and applicable concept for the management of AE. Methods: Based on a systematic literature review, we developed an evidence-based severity-score-oriented treatment algorithm for AE and compared its effectiveness to that of an individualised symptom-oriented treatment (individual therapy) in a randomised controlled trial. Sixty-three participants were randomised to algorithm (n = 32) or individual therapy (n = 31) and treated accordingly for 12 months. Study end points included difference between baseline SCORAD and mean SCORAD under treatment (primary end point), quality of life and treatment utilisation. Analysis was by intention to treat (registration: ClinicalTrials.gov:NCT00148746). Results: No statistically significant differences in clinical or subjective response were observed between groups. Treatment following the algorithm and individual treatment both effectively controlled AE. Mean SCORAD reductions were 47% (95% confidence interval, CI = 38–55; algorithm) and 42% (95% CI = 29–54; individual). Clinical response was paralleled by improved quality of life in both groups. Physicians adhered to the algorithm option in 93% of their treatment decisions. Conclusion: Treatment following an evidence-based algorithm is an effective and applicable concept for the management of AE but does not show clear advantages compared to individualised treatment in a dermatological setting. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

No description available.

Background: Regular physical activity (PA) is critical for children’s health and wellbeing. Despite the numerous health benefits, most Canadian children do not meet the Canadian PA guidelines. The emergence of the COVID-19 pandemic and social restrictions added new challenges to meeting the PA guidelines. Mobile health (mHealth) technology can be leveraged to promote PA among children. Combining gamification with mHealth interventions has the potential to further improve program effectiveness. Thus, “Draco” was developed as a virtual pet smartphone app to increase PA in children using self-determination theory as a framework to promote intrinsic motivation for PA. Objective: The primary objective is to evaluate the satisfaction and acceptability of the Draco app after four weeks. Secondary objectives include evaluating the preliminary effectiveness of the Draco app to improve average daily steps, average daily MVPA, perceived autonomy for PA, perceived competence for PA, and perceived relatedness to the app. Methods: 43 Canadian children, aged 8-14 years old, not meeting the Canadian PA guidelines of 60min of MVPA per day were randomly allocated to an intervention or control group. Participants in the control group used a step-tracking app for four weeks. Intervention participants were instructed to use the Draco app. Participants completed a baseline and follow-up questionnaire. PA outcomes were tracked using a Fitbit provided to each participant. Intrinsic PA motivation was assessed using an adapted version of the Intrinsic Motivation Inventory (IMI). Intrinsic motivation was assessed using the satisfaction subscale. Exit interviews were completed to determine app acceptability. Results: Participants demonstrated high levels of satisfaction and acceptability with the Draco app 2.83 (1.29). Intervention participants increased their average daily steps by 909 (1701). The control group increased their steps by 46 (1507). The Draco app had a small effect on promoting steps, MVPA, relatedness and small effects at increasing autonomy and competence. Conclusion: Participants demonstrated high levels of satisfaction and acceptability with the app. Participants in the intervention group showed greater increases in PA with small effect sizes. Preliminary evidence highlights the importance of tailoring game design to the users. Technical limitations impacted recruitment and user experiences. Additional development time should be taken to stabilize the app and add new game features for a definitive RCT. / Graduate

Le traumatisme craniocérébral léger (TCCL) s'accompagne d'une constellation de symptômes de nature variée, appelés symptômes post-commotionnels (SPC). La majorité des patients se rétablissent complètement et rapidement, à savoir dans le mois qui suit l'accident. Cependant, 10 à 20 % d'entre eux présentent un rétablissement prolongé avec des SPC persistants (SPCP), lesquels entravent la qualité de vie, l'intégration à la communauté et le retour aux activités. Pour la minorité de patients présentant des SPCP, il est donc nécessaire d'intervenir au-delà de la psychoéducation préventive aiguë recommandée par les guides de pratique. Or, il existe très peu d'interventions visant spécifiquement à outiller ces patients afin de diminuer les SPC et ainsi, accélérer le rétablissement. En effet, à l’heure actuelle, les interventions psychologiques et psychoéducatives développées spécifiquement pour la phase post-aiguë, qui prend place entre les phases aiguë (0-1 mois après le TCCL) et chronique (> 6 mois post-accident), sont particulièrement rares. Les quelques études existantes plaident en faveur d'une approche brève de quelques séances de psychoéducation et/ou de soutien. Cependant, il s'agit de données préliminaires et de nombreuses inconnues subsistent encore quant au format idéal (ex. : en personne vs par téléphone, individuel vs en groupe, nombre de séances, contenu précis). En outre, la pauvre qualité méthodologique des études complique significativement les interprétations possibles à ce sujet (ex. : absence de groupe contrôle, groupes non randomisés). L'objectif principal de cette thèse était donc de développer une nouvelle intervention de psychoéducation et de soutien destinée aux personnes en phase post-aiguë du rétablissement post-TCCL, et d’explorer sa faisabilité ainsi que son efficacité. L'objectif du premier article de la thèse (Chapitre 2) était de remédier à la pauvreté de la littérature en ce qui a trait, d'une part, à la description des protocoles d'intervention de psychoéducation et, d'autre part, relativement à leurs assises théoriques. Il avait donc pour objectif de présenter la démarche théorique et méthodologique associée au développement de l'intervention SAAM, un programme de quatre séances d'intervention individuelles d’une heure, données en personne, et visant chacune un type de SPC fréquent en phase post-aiguë : Sommeil/fatigue, Attention, Anxiété/humeur, Mémoire/organisation. Le programme offre de l'information au patient, le rassure sur son rétablissement et l'accompagne vers un retour graduel aux activités, en l'outillant à cet effet. Cette approche est ancrée dans un modèle théorique intégratif de persistance des symptômes (Hou et al., 2012), dont les composantes sont expliquées dans l'article. Celui-ci permet non seulement de mieux saisir les fondements théoriques associés à la création du nouvel outil d'intervention, mais en dévoile également son contenu. Il met donc en lumière une démarche qui s'inscrit parfaitement dans un effort de clarification et de transparence, essentiel au progrès de la recherche interventionnelle. Plus largement, ce travail permettra de faciliter la réplication scientifique et de soutenir le transfert de connaissances vers les milieux cliniques. Le deuxième article de la thèse (Chapitre 3) avait pour objectif d'estimer la faisabilité et d’explorer l'effet de l'intervention SAAM auprès de patients symptomatiques en phase post-aiguë de leur rétablissement. Une étude pilote d’essai contrôlé randomisé à deux groupes parallèles (expérimental, n = 13 et liste d'attente, n = 12) a permis de démontrer la faisabilité et la tolérance à l’intervention SAAM. Les données préliminaires suggèrent un effet de l’intervention sur la diminution des SPC en général. En ce qui a trait plus directement aux SPC visés par l'intervention SAAM, une amélioration des plaintes reliées aux symptômes dépressifs, à la fatigue et à la perception de la qualité du sommeil a été mise en évidence à la suite de l'intervention. Cependant, l’étude n'a pas montré d’effet bénéfique du programme SAAM en termes de plaintes somatiques ni de performance cognitive (attention, mémoire). De plus, aucun effet n'a été observé sur le plan de l'intégration à la communauté. Des analyses supplémentaires (Chapitre 4) suggèrent que l'intervention SAAM pourrait restaurer le besoin de compétence, un besoin psychologique fondamental intimement relié au bien-être des individus. Enfin, des analyses supplémentaires portant sur un questionnaire de satisfaction face à l'intervention confirment un haut taux de satisfaction des participants face à l'intervention, ce qui est de bon augure pour l'implémentation en milieux cliniques. Par son aspect novateur, son format standardisé bref et facilement accessible, ainsi que ses effets objectivés sur plusieurs SPCP particulièrement invalidants à la suite du TCCL, le programme d'intervention SAAM est prometteur. La portée clinique de cette thèse est donc particulièrement importante et est discutée, avec ses limites et les avenues de recherche futures, dans le dernier chapitre. Ces résultats soulignent l'importance de poursuivre la recherche dans le champ des interventions post-TCCL, afin d’outiller les cliniciens et d’offrir les meilleurs soins possibles aux patients ayant subi un TCCL. / Mild traumatic brain injury (mTBI) is accompanied by a constellation of manifestations known as post-concussive symptoms (PCS). The majority of patients recover completely and promptly, i.e. within one month of injury. However, 10-20 % experience prolonged recovery with persistent PCS (PPCS), which impact quality of life, community integration and resumption of activities. For the minority of patients who present PPCS, it is necessary to provide them with resources beyond the acute preventive psychoeducation recommended by practice guidelines. However, there are very few interventions available to reduce PCS and thus enhance recovery. To date, psychological and psychoeducational interventions developed specifically for the post-acute phase, which takes place between the acute (0-1 month after mTBI) and the chronic phase (> 6 months post-injury), are particularly rare. The scarce existing evidence suggests that the optimal intervention should be brief, including a few sessions of psychoeducation and/or counseling. Nevertheless, these are preliminary data and many open questions remain regarding the optimal format (e.g., in person vs. on the phone, individual vs. group, number of sessions, specific content). Moreover, the poor methodological quality of previous intervention studies significantly complicate interpretations (e.g., absence of control groups, non-randomized groups). The main objective of this thesis was therefore to develop and explore the feasibility and treatment effect of a novel psychoeducational and counseling intervention program for the post-acute phase after mTBI. The objective of the first article of the thesis (Chapter 2) was to overcome the paucity of work describing psychoeducational intervention protocols and their theoretical underpinnings. The article therefore aimed to present the theoretical and methodological approach associated with the development of the SAAM intervention. SAAM is a program including four 1-hour individual intervention sessions given in person, each targeting a type of common PCS in the post-acute phase: Sleep/fatigue, Attention, Anxiety/mood, Memory/organization. It informs the patient, provides reassurance about recovery, and supports the gradual resumption of activities by giving the patient the tools to do so. This approach is anchored in an integrative theoretical model of symptom persistence (Hou et al., 2012), the components of which are explained in the article. The latter provides a better understanding of the theoretical rationale behind the development of the SAAM intervention, and includes a detailed description of the protocol. The article is meant to align with efforts to clarify the theoretical underpinnings of the intervention program and enhance transparency in scientific reporting, an essential step in the advancement of interventional research. More broadly, this work will facilitate scientific replication and knowledge transfer in clinical settings. The second article (Chapter 3) aimed to estimate feasibility and explore the treatment effect of the SAAM intervention in symptomatic patients during the post-acute phase. A pilot randomized controlled trial with two parallel groups (experimental, n = 13 and wait list, n = 12) demonstrated the feasibility and tolerability of the intervention. Preliminary data suggest an effect of the intervention in reducing overall PCS. More specifically, regarding the PCS targeted by the SAAM intervention, an improvement in complaints related to depressive symptoms, fatigue, and sleep quality perception was observed post-intervention. However, the intervention failed to show a positive effect in addressing anxiety or somatic complaints, nor was it significantly impactful in improving cognitive performance (attention, memory). No effect was observed in terms of community integration either. Nonetheless, additional analyses (Chapter 4) suggest that SAAM intervention might restore the need for competence, a basic psychological need closely related to the individual's well-being. Finally, additional analyses pertaining to an intervention satisfaction questionnaire confirm that participants report a high level of satisfaction with the intervention, which bodes well for clinical implementation. The SAAM intervention holds promise because of its innovative aspect, its brief and easily accessible standardized format, and its demonstrated effects on several disabling PCS. The clinical significance of this thesis is notable and is discussed, along with study limitations and future avenues of research, in the final chapter. This work emphasizes the importance of pursuing research efforts in the field of post-mTBI interventions, in order to provide clinicians with the tools they need to offer the best possible care to patients who have sustained mTBI.

BACKGROUND: Tinnitus is a symptom that can be very distressing owing to hearing sounds not related to any external sound source. Managing tinnitus is notoriously difficult, and access to evidence-based care is limited. Cognitive behavioral therapy (CBT) is a tinnitus management strategy with the most evidence of effectiveness but is rarely offered to those distressed by tinnitus. The provision of internet-based CBT for tinnitus overcomes accessibility barriers; however, it is not currently readily available in the United States. OBJECTIVE: The aim of this study is to investigate the efficacy of internet-based CBT compared with that of weekly monitoring for the management of tinnitus in reducing tinnitus distress; reducing tinnitus-related comorbidities, including tinnitus cognitions, insomnia, anxiety, and depression; and assessing the stability of the intervention effects 2 months after the intervention. METHODS: A 2-arm randomized clinical trial comparing audiologist-guided internet-based CBT (n=79) to a weekly monitoring group (n=79) with a 2-month follow-up assessed the efficacy of internet-based CBT. Eligible participants included adults seeking help for tinnitus. Recruitment was conducted on the web using an open-access website. Participants were randomized via 1:1 allocation, but blinding was not possible. The study was undertaken by English or Spanish speakers on the web. The primary outcome was a change in tinnitus distress as measured using the Tinnitus Functional Index. Secondary outcome measures included anxiety, depression, insomnia, tinnitus cognition, hearing-related difficulties, and quality of life. RESULTS: Internet-based CBT led to a greater reduction in tinnitus distress (mean 36.57, SD 22) compared with that in weekly monitoring (mean 46.31, SD 20.63; effect size: Cohen d=0.46, 95% CI 0.14-0.77) using an intention-to-treat analysis. For the secondary outcomes, there was a greater reduction in negative tinnitus cognition and insomnia. The results remained stable over the 2-month follow-up period. No important adverse events were observed. Further, 16% (10/158) of participants withdrew, with low overall compliance rates for questionnaire completion of 72.3% (107/148) at T1, 61% (91/148) at T2, and 42% (62/148) at T3. CONCLUSIONS: This study is the first to evaluate and indicate the efficacy of audiologist-delivered internet-based CBT in reducing tinnitus distress in a US population. It was also the first study to offer internet-based CBT in Spanish to accommodate the large Hispanic population in the United States. The results have been encouraging, and further work is indicated in view of making such an intervention applicable to a wider population. Further work is required to improve compliance and attract more Spanish speakers. TRIAL REGISTRATION: ClinicalTrials.gov NCT04004260; https://clinicaltrials.gov/ct2/show/NCT04004260.

Background: In the treatment of diabetes mellitus, the challenge is to integrate adequate self-management into clinical care. Customization including goal setting, monitoring, and feedback could be achieved through digitization. Digital linking between different devices could simplify and promote self-management. The aim of this study is to evaluate the outcome of diabetes treatment assisted by a digital health application compared with standard diabetes therapy. - Methods: The DAVOS study is a 6-month-period prospective, multicentric, randomized controlled trial. In total, 154 diabetes patients (age ≥18; treated with insulin) will be recruited and randomized into control group or intervention group. Both groups will receive standard diabetes care. The intervention group will additionally use a diabetes app. HbA1c value will be monitored on three separate defined visits. Primary endpoint is the overall reduction of HbA1c value. Secondary endpoints (eg, usability of the app) will be determined through patient-reported outcome questionnaires. - Discussion: Through enhanced interaction of health care professionals, providers of the app, and patients, the study aims to demonstrate improvement in the self-management of diabetes. As part of the closure management, all patients will be invited to use the examined application after completion of the study. The DAVOS study will be conducted in accordance with the valid version of the present study protocol and the internationally recognized International Conference on Harmonization–Good Clinical Practice (ICH-GCP) Guidelines. Special attention will be paid to European, national, and regional requirements for the approval, provision, and use of medical devices. The study was registered in the German Register of Clinical Trials (DRKS) with number DRKS00025996.

Introduction: Quality improvement (QI) encompasses a wide range of healthcare studies and activities with the common goal of improving patient outcomes, healthcare system performance, and professional development. QI is characterized by a diversity of definitions, stakeholders, clinical fields and study designs, which creates challenges for rigorous reporting and evaluation of these studies. Understanding and addressing the methodological issues that arise from conducting QI studies from multiple clinical disciplines is critical for generating good evidence for healthcare improvement to tackle health system challenges. Objectives: This thesis addressed three independent objectives: (i) Determine the quality of reporting of QI studies in neonatology. (ii) Compare different statistical methods that can be used to analyze data from a cluster randomized controlled trial with repeated measures data and examine how the estimate of intervention effects varies between these approaches. (iii) Determine the cost-effectiveness of providing timely surgery or timely rehabilitation for patients with hip fracture. Methods: Objective 1: We conducted a systematic survey of quality improvement studies in neonatology to examine the extent to which these publications adhered to SQUIRE 2.0, the guidelines for reporting studies that sought to improve the quality, safety, and value of healthcare. Using the same set of articles, we examined how various methodological attributes, such as stakeholder engagement, outcome measures, and statistical process controls, are reported in these studies. Objective 2: To compare the differences in the statistical estimates of intervention effects between linear mixed models and Generalized Estimating Equations, for the CP@Clinic Program cluster randomized RCT, which contains routinely collected monthly outcome data aggregated at the cluster level. Objective 3: We constructed a Markov cohort model to estimate the cost-effectiveness of receiving timely surgery within 24 hours of admission to the emergency department, receiving immediate admission to inpatient rehabilitation following acute care discharge, receiving both, or none. Results: Objective 1: In our assessment of reporting quality, we found that adherence to SQUIRE 2.0 guidelines was inadequate and that journals should endorse the SQUIRE 2.0 guideline for improvement publications to alleviate this issue. We found that process measures was the most frequently reported methodological attribute (89%), while stakeholder engagement with leadership (32%) or caregivers (10%) were infrequently reported or conducted. Objective 2: In comparing statistical methods for analyzing a cluster randomized controlled trial with correlated data, we found that it was critical to apply a correction to the variance estimator of generalized estimating equations to produce robust estimates of the intervention effects. Objective 3: In our economic evaluation, both timely surgery alone and the combination of timely surgery and timely rehabilitation yielded cost-effective improvements in the quality-adjusted life-years of patients with hip fracture. However, the combination of receiving timely surgery and timely rehabilitation requires a high willingness-to-pay threshold, above $128,000 per quality-adjusted life-years, to be considered cost-effective. Conclusions: Overall, understanding the state of reporting and the broad spectrum of methods and methodologic issues for evaluating quality improvement initiatives will advance its rigorous research, evaluation, reporting, and contribution towards informed decision-making for tackling pressing healthcare issues. / Thesis / Doctor of Philosophy (PhD) / Quality improvement (QI) is a field of healthcare research that can be defined in many ways, and research in this field is conducted by researchers from various medical disciplines. Consequently, challenges may arise in reporting and evaluating QI interventions. Thus, it is important to examine how QI interventions are reported in academic literature and the methods used to evaluate their effectiveness in improving health. The current thesis aims to address these issues through three independent objectives: (1) examine the details reported in QI studies in neonatology, (2) compare different statistical methods that can be used to analyze data from a community paramedicine cluster randomized controlled trial, and (3) investigate whether providing timely surgery and timely hospital-based rehabilitation is a cost-effective way to improve the quality of life of patients who have experienced hip fracture. The findings of these studies will provide insights into the challenges of reporting and evaluating QI interventions, and suggest ways to improve them.