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Introduction: Depression often co-occurs with chronic back pain (CBP). Internet and mobile-based interventions (IMIs) might be a promising approach for effectively treating depression in this patient group. In the present study, we will evaluate the effectiveness and cost-effectiveness of a guided depression IMI for individuals with CBP (eSano BackCare-D) integrated into orthopaedic healthcare., Methods and Analysis: In this multicentre randomised controlled trial of parallel design, the groups eSano BackCare-D versus treatment as usual will be compared. 210 participants with CBP and diagnosed depression will be recruited subsequent to orthopaedic rehabilitation care. Assessments will be conducted prior to randomisation and 9 weeks (post-treatment) and 6 months after randomisation. The primary outcome is depression severity (Hamilton Rating Scale for Depression-17). Secondary outcomes are depression remission and response, health-related quality of life, pain intensity, pain-related disability, self-efficacy and work capacity. Demographic and medical variables as well as internet affinity, intervention adherence, intervention satisfaction and negative effects will also be assessed. Data will be analysed on an intention-to-treat basis with additional per-protocol analyses. Moreover, a cost-effectiveness and cost-utility analysis will be conducted from a societal perspective after 6 months., Ethics and Dissemination: All procedures are approved by the ethics committee of the Albert-Ludwigs-University of Freiburg and the data security committee of the German Pension Insurance (Deutsche Rentenversicherung). The results will be published in peer-reviewed journals and presented on international conferences., Trial Registration Number: DRKS00009272; Pre-results., Competing Interests: Competing interests: JL, LS, SP, SS, JB, SN, OM, HR and HB report no conflict of interest. DE, MB and DL are stakeholders of the ’Institute for Online Health Trainings', a company aiming to transfer scientific knowledge related to the present research into routine healthcare. A committee of independent scientists has been formed (Data Safety and Monitoring Board (DSMB)) to supervise study-related decisions and prevent any influence of a potential conflict of interest., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Depression is a very common, severe, socio-economically highly relevant disorder and the main cause for approximately 10,000 suicides in Germany annually. There is capital room for improvement and optimization of the care for depressed patients, as effective and evidence-based treatment options are available. However, they are only used optimally by a minority of the people affected due to huge diagnostic and therapeutic deficits. The "Compentence Network on Depression and Suicidality" provided several evidence-based concepts to improve care for patients affected by depression and to prevent suicidal behaviour. Especially the four-level intervention approach of the Alliances Against Depression has been successfully adapted and implemented by more than 100 regions within Europe and globally as well. The infrastructure of the Competence Network could be efficiently sustained throughout the establishment of the German Depression Foundation and the European Alliance against Depression. Since 2014, all research activities have been extended nationally and internationally by the establishment of a Depression Research Centre with a special focus on various E‑Mental-Health-projects.

Background: Internet-based interventions produce comparable effectiveness rates as face-to-face therapy in treating depression. Still, more than half of patients do not respond to treatment. Machine learning (ML) methods could help to overcome these low response rates by predicting therapy outcomes on an individual level and tailoring treatment accordingly. Few studies implemented ML algorithms in internet-based depression treatment using baseline self-report data, but differing results hinder inferences on clinical practicability. This work compares algorithms using features gathered at baseline or early in treatment in their capability to predict non-response to a 6-week online program targeting depression. Methods: Our training and test sample encompassed 1270 and 318 individuals, respectively. We trained random forest algorithms on self-report and process features gathered at baseline and after 2 weeks of treatment. Non-responders were defined as participants not fulfilling the criteria for reliable and clinically significant change on PHQ-9 post-treatment. Our benchmark models were logistic regressions trained on baseline PHQ-9 sum or PHQ-9 early change, using 100 iterations of randomly sampled 80/20 train-test-splits. Results: Best performances were reached by our models involving early treatment characteristics (recall: 0.75–0.76; AUC: 0.71–0.77). Therapeutic alliance and early symptom change constituted the most important predictors. Models trained on baseline data were not significantly better than our benchmark. Conclusions: Fair accuracies were only attainable by involving information from early treatment stages. In-treatment adaptation, instead of a priori selection, might constitute a more feasible approach for improving response when relying on easily accessible self-report features. Implementation trials are needed to determine clinical usefulness. [ABSTRACT FROM AUTHOR]

Background: E‑mental health mainly plays a role in the outpatient treatment of patients with depressive disorders. The goal of this study was to implement and evaluate the web-based, therapist-guided self-management tool "iFightDepression" (iFD) to clarify if there is a benefit for inpatient use. Material and methods: In this study 78 inpatients with affective disorders (ICD-10 F32.0‑3, F33.0-3) or dysthymia (F34) were recruited. The intervention duration with the iFD tool went from admission until discharge, therapeutic support was granted by the ward staff. Symptom severity, intervention expectations and experience with therapy were processed in an online questionnaire before the intervention (T0) while intervention satisfaction was captured after the intervention shortly before discharge (T1) in a paper-pencil questionnaire. Results: Out of 78 participating inpatients 42 used the iFD tool at least once. Moderate to high levels of expectation regarding the iFD tool and mildly above-average level of satisfaction after the intervention were observed. Of the active users 67% indicated they would continue to use the iFD tool after discharge. The main reasons for not using the iFD tool were short duration of stay, severity of disease and lack of digital literacy. Conclusion: An implementation of the iFD tool is feasible on principle. Active users gave positive feedback concerning the intervention and most participants claimed to continue using the iFD tool after discharge; however, low usage rates among study participants (42/78, 54%) showed barriers of implementation that have to be addressed and underline the importance of adaptations regarding the use of the intervention in a clinical setting. [ABSTRACT FROM AUTHOR]

Abstract Background Depressive disorders often remain undiagnosed or are treated inadequately. Online-based programs may reduce the present treatment gap for depressive disorders and reduce disease-related costs. This study aimed to examine the potential of the internet intervention “deprexis” to reduce the total costs of statutory health insurance. Changes in depression severity, health-related quality of life and impairment in functioning were also examined. Method A total of 3805 participants with, at minimum, mild depressive symptoms were randomized to either a 12-week online intervention (deprexis) or a control condition. The primary outcome measure was statutory health insurance costs, estimated using health insurers’ administrative data. Secondary outcomes were: depression severity, health-related quality of life, and impairment in functioning; assessed on patient’s self-report at baseline, post-treatment, and three-months’ and nine-months’ follow-up. Results In both groups, total costs of statutory health insurance decreased during the study period, but changes from baseline differed significantly. In the intervention group total costs decreased by 32% from 3139€ per year at baseline to 2119€ in the study year (vs. a mean reduction in total costs of 13% in the control group). In comparison to the control group, the intervention group also showed a significantly greater reduction in depression severity, and impairment in functioning and a significantly greater increase in health-related quality of life. Conclusion The study underlines the potential of innovative internet intervention programs in treating depressive disorders. The results suggest that the use of deprexis over a period of 12 weeks leads to a significant improvement in symptoms with a simultaneous reduction in the costs of statutory health insurance.

Abstract Background Depression often remains undiagnosed or treated inadequately. Web-based interventions for depression may improve accessibility of treatment and reduce disease-related costs. This study aimed to examine the potential of the web-based cognitive behavioral intervention “deprexis” in reducing disease-related costs. Methods Participants with mild to moderate depressive symptoms were recruited and randomized to either a 12-week web-based intervention (deprexis) in addition to care as usual (intervention group) or care as usual (control group). Outcome measures were health-related resource use, use of medication and incapacity to work as well as relating direct health care costs. Outcomes were assessed on patients’ self-report at baseline, three months and six months. Results A total of 1013 participants were randomized. In both groups total direct health care costs decreased during the study period, but changes from baseline did not significantly differ between study groups. Numeric differences between study groups existed in outpatient treatment costs. They could be attributed to differences in changes of costs for psychotherapeutic treatment from baseline. Whereas costs for psychotherapeutic treatment decreased in the intervention group, costs increased in the control group (− 16.8% (€80) vs. + 14.7% (€60)) (tdf = 685 = 2.57; p = 0.008). Conclusion The study indicates the health economic potential of innovative e-mental-health programs. There is evidence to suggest that the use of deprexis over a period of 12 weeks leads to a decrease in outpatient treatment cost, especially in those related to different types of psychotherapeutic treatment.

Introduction: Internet- and mobile-based interventions (IMIs) and their integration into routine psychotherapy (i.e., blended therapy) can offer a means of complementing psychotherapy in a flexible and resource optimized way. Objective: The present study will evaluate the non-inferiority, cost-effectiveness, and safety of two versions of integrated blended psychotherapy for depression and anxiety compared to standard cognitive behavioral therapy (CBT). Methods: A three-armed multicenter cluster-randomized controlled non-inferiority trial will be conducted comparing two implementations of blended psychotherapy (PSYCHOnlineTHERAPYfix/flex) compared to CBT. Seventy-five outpatient psychotherapists with a CBT-license will be randomized in a 1:1:1 ratio. Each of them is asked to include 12 patients on average with depressive or anxiety disorders resulting in a total sample size of N = 900. All patients receive up to a maximum of 16 psychotherapy sessions, either as routine CBT or alternating with Online self-help sessions (fix: 8/8; flex: 0–16). Assessments will be conducted at patient study inclusion (pre-treatment) and 6, 12, 18, and 24 weeks and 12 months post-inclusion. The primary outcome is depression and anxiety severity at 18 weeks post-inclusion (post-treatment) using the Patient Health Questionnaire Anxiety and Depression Scale. Secondary outcomes are depression and anxiety remission, treatment response, health-related quality of life, patient satisfaction, working alliance, psychotherapy adherence, and patient safety. Additionally, several potential moderators and mediators including patient characteristics and attitudes toward the interventions will be examined, complemented by ecological day-to-day digital behavior variables via passive smartphone sensing as part of an integrated smart-sensing sub-study. Data-analysis will be performed on an intention-to-treat basis with additional per-protocol analyses. In addition, cost-effectiveness and cost-utility analyses will be conducted from a societal and a public health care perspective. Additionally, qualitative interviews on acceptance, feasibility, and optimization potential will be conducted and analyzed. Discussion: PSYCHOnlineTHERAPY will provide evidence on blended psychotherapy in one of the largest ever conducted psychotherapy trials. If shown to be non-inferior and cost-effective, PSYCHOnlineTHERAPY has the potential to innovate psychotherapy in the near future by extending the ways of conducting psychotherapy. The rigorous health care services approach will facilitate a timely implementation of blended psychotherapy into standard care. Trial Registration: The trial is registered in the German Clinical Trials Register (DRKS00023973; date of registration: December 28th 2020). [ABSTRACT FROM AUTHOR]

Background: Depressive disorders often remain undiagnosed or are treated inadequately. Online-based programs may reduce the present treatment gap for depressive disorders and reduce disease-related costs. This study aimed to examine the potential of the internet intervention "deprexis" to reduce the total costs of statutory health insurance. Changes in depression severity, health-related quality of life and impairment in functioning were also examined. Method: A total of 3805 participants with, at minimum, mild depressive symptoms were randomized to either a 12-week online intervention (deprexis) or a control condition. The primary outcome measure was statutory health insurance costs, estimated using health insurers' administrative data. Secondary outcomes were: depression severity, health-related quality of life, and impairment in functioning; assessed on patient's self-report at baseline, post-treatment, and three-months' and nine-months' follow-up. Results: In both groups, total costs of statutory health insurance decreased during the study period, but changes from baseline differed significantly. In the intervention group total costs decreased by 32% from 3139€ per year at baseline to 2119€ in the study year (vs. a mean reduction in total costs of 13% in the control group). In comparison to the control group, the intervention group also showed a significantly greater reduction in depression severity, and impairment in functioning and a significantly greater increase in health-related quality of life. Conclusion: The study underlines the potential of innovative internet intervention programs in treating depressive disorders. The results suggest that the use of deprexis over a period of 12 weeks leads to a significant improvement in symptoms with a simultaneous reduction in the costs of statutory health insurance. [ABSTRACT FROM AUTHOR]

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Hintergrund: Ziel der Studie ist es, die Wirkung eines smartphonegestützten kognitiv-behavioralen Rehabilitationsnachsorgeprogramms (eATROS) für Patienten mit depressiven Störungen zu überprüfen, die mit Erfolg an einer stationären psychosomatischen Rehabilitationsmaßnahme teilgenommen hatten. eATROS dient dazu, den Behandlungserfolg zu sichern und Rückfällen vorzubeugen. Die Smartphone-Anwendung soll die Patienten in den ersten 3 Monaten nach Entlassung bei der Umsetzung ihrer antidepressiven Verhaltensstrategien unterstützen. Methoden: Die Studie wurde als prospektive Kontrollgruppenstudie realisiert, mit ambulanter, poststationärer Regelversorgung (TAU) als Kontrollbedingung (KG) und einer Experimentalgruppe (EG), die zusätzlich Nachsorge mit eATROS erhielt. In die Studie aufgenommen und den beiden Versuchsgruppen in wochenweise gebildeten Kohorten zufällig zugewiesen wurden Patienten mit affektiven Störungen als Hauptbehandlungsdiagnose, die im Zuge der Behandlung eine einzelfallstatistisch signifikante Besserung ihrer depressiven Symptomatik erzielt hatten. Patienten der EG erhielten das Angebot, eATROS in den ersten 3 Monaten nach ihrer Entlassung in Anspruch zu nehmen. Am Anfang und Ende dieser poststationären Phase wurden die Depressivität und depressionsrelevante Selbstregulationskompetenzen als Zielgrößen erhoben. Ergebnisse: Im Vergleich zu den Patienten der KG (n = 42) gelang es den Patienten der EG (n = 50) ihre während der stationären Rehabilitationsmaßnahme erreichte Reduktion der Depressionssymptomatik besser aufrechtzuerhalten. Hinsichtlich der Selbstregulationskompetenzen ließ sich die Überlegenheit der eATROS-Nachsorge gegenüber der KG für 2 der 5 eingesetzten Skalen nachweisen: Die Patienten der eATROS-Nachsorge wiesen eine günstigere Entwicklung ihrer Kompetenzen auf, sich selbst zu motivieren und Absichten umzusetzen, als die Patienten der KG. Diskussion: Die Wirkkomponenten der eATROS-Intervention werden diskutiert und Möglichkeiten und Grenzen für den Transfer in die Versorgungspraxis erörtert. Schlussfolgerung: Die Ergebnisse sprechen - mit methodischen Einschränkungen - für die Überlegenheit der smartphonegestützten Rehabilitationsnachsorge gegenüber poststationärer Regelversorgung allein. [ABSTRACT FROM AUTHOR]