Feasibility and potential efficacy of a guided internet- and mobile-based CBT for adolescents and young adults with chronic medical conditions and comorbid depression or anxiety symptoms (youthCOACHCD): a randomized controlled pilot trial.

BACKGROUND: Adolescents and young adults (AYA) with a chronic medical condition show an increased risk for developing mental comorbidities compared to their healthy peers. Internet- and mobile-based cognitive behavioral therapy (iCBT) might be a low-threshold treatment to support affected AYA. In this randomized controlled pilot trial, the feasibility and potential efficacy of youthCOACHCD, an iCBT targeting symptoms of anxiety and depression in AYA with chronic medical conditions, was evaluated. METHODS: A total of 30 AYA (Mage 16.13; SD= 2.34; 73% female), aged 12-21 years either suffering from cystic fibrosis, juvenile idiopathic arthritis or type 1 diabetes, were randomly assigned to either a guided version of the iCBT youthCOACHCD (IG, n=15) or to a waitlist control group (CG, n=15), receiving an unguided version of the iCBT six months post-randomization. Participants of the IG and the CG were assessed before (t0), twelve weeks after (t1) and six months after (t2) randomization. Primary outcome was the feasibility of the iCBT. Different parameters of feasibility e.g. acceptance, client satisfaction or potential side effects were evaluated. First indications of the possible efficacy with regard to the primary efficacy outcome, the Patient Health Questionnaire Anxiety and Depression Scale, and further outcome variables were evaluated using linear regression models, adjusting for baseline values. RESULTS: Regarding feasibility, intervention completion was 60%; intervention satisfaction (M = 25.42, SD = 5.85) and perceived therapeutic alliance (M = 2.83, SD = 1.25) were moderate and comparable to other iCBTs. No patterns emerged regarding subjective and objective negative side effects due to participation in youthCOACHCD. Estimates of potential efficacy showed between group differences, with a potential medium-term benefit of youthCOACHCD (ß = -0.55, 95%CI: -1.17; 0.07), but probably not short-term (ß = 0.20, 95%CI: -0.47; 0.88). CONCLUSIONS: Our results point to the feasibility of youthCOACHCD and the implementation of a future definitive randomized controlled trial addressing its effectiveness and cost-effectiveness. Due to the small sample size, conclusions are premature, however, further strategies to foster treatment adherence should be considered. TRIAL REGISTRATION: The trial was registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (ID: DRKS00016714 , 25/03/2019).

[Psychotherapy of depressive disorders : Procedures, evidence and perspectives]. / Psychotherapie depressiver Störungen : Verfahren, Evidenz und Perspektiven.

BACKGROUND: Depressive disorders are associated with a high burden of suffering and significantly reduce the well-being and the self-esteem of affected patients. Psychotherapy is one of the main treatment options for depressive disorders. OBJECTIVE: The aim of this article is to present the current evidence for antidepressive psychotherapeutic treatments. MATERIAL AND METHODS: During the revision of the German S3- and National Disease Management Guideline (NDMG) on unipolar depression in 2015, a comprehensive and systematic evidence search was conducted. The results of this search along with a systematic update are summarized. RESULTS: The most intensively investigated psychotherapeutic method is cognitive behavioral therapy (CBT), which proved to be effective in many trials. Evidence also exists for psychodynamic psychotherapy and interpersonal therapy (IPT), followed by systemic therapy and client-centered psychotherapy; however, the evidence is less robust. CONCLUSION: Psychotherapy alone or in combination with pharmacotherapy was shown to be an effective treatment option. Psychotherapy represents a key element in the treatment of depressive disorders.

[Psychotherapy of depressive disorders: Evidence in chronic depression and comorbidities]. / Psychotherapie depressiver Störungen: Evidenz bei chronischer Depression und bei Komorbidität.

BACKGROUND: Psychotherapy has been shown to be an effective treatment option for depressive disorders; however, its effectiveness varies depending on patient and therapist characteristics and the individual form of the depressive disorder. OBJECTIVES: The aim of this article is to present the current evidence for psychotherapeutic antidepressive treatments for patients with chronic and treatment-resistant depression as well as for patients with mental and somatic comorbidities. MATERIAL AND METHODS: During the revision of the currently valid German S3- and National Disease Management Guideline (NDMG) on unipolar depression published in 2015, a comprehensive and systematic evidence search including psychotherapy for specific patient groups was conducted. The results of this search along with a systematic update are summarized. RESULTS: Psychotherapy has been shown to be effective in reducing depressive symptoms in patients suffering from chronic and treatment-resistant depression and in patients with mental and somatic comorbidities. The evidence is insufficient particularly for patients with mental comorbidities. CONCLUSION: Based on the current evidence and clinical expertise the NDMG recommends psychotherapy alone or in combination with pharmacotherapy to treat most of these depressive patient groups. Evidence gaps were identified, which highlight the need for further research.

The 6-month effectiveness of Internet-based guided self-help for depression in adults with Type 1 and 2 diabetes mellitus.

AIM: The aim of this research is to examine the 6-month effects of an Internet-based guided self-help intervention for comorbid depressive symptoms in people with diabetes. METHODS: Participants (n = 260) with Type 1 or 2 diabetes and elevated depressive symptoms [Center for Epidemiological Studies Depression Scale (CES-D) ≥ 23] were randomly assigned to a guided Internet-based self-help intervention or a control condition (treatment as usual + online psychoeducation about depression). The primary outcome was a change in depressive symptom severity (CES-D) from baseline to 6-month follow-up. The secondary outcomes included numbers of people achieving treatment response (reliable change of depressive symptoms) and remission (CES-D ≤ 16), as well as the effects on glycaemic control, diabetes-related emotional distress and diabetes acceptance. Repeated measures analysis of variance examined between-group differences using intent-to-treat principles. RESULTS: Both conditions showed improvements in depression severity: intervention condition, d = 1.48 [95% confidence interval (95% CI): 1.21 to 1.76]; control condition d = 0.55 (95% CI: 0.30 to 0.80). Changes were significantly greater in the intervention condition with a large between-group effect size (d = 0.83, 95% CI: 0.57 to 1.08). Accordingly, effects on response [relative risk (RR) = 2.60 (95% CI: 2.01 to 3.36), P < 0.001] and remission [RR = 3.36 (95% CI: 2.98 to 5.44), P < 0.001] were in favour of the intervention group, as were differences in change in diabetes emotional distress (d = 0.50, 95% CI: 0.04 to 0.54), and physical and mental functioning [Short Form Health Survey (SF-12) Physical d = 0.27 (95% CI: 0.01 to 0.51) and SF-12 Mental d = 0.68 (95% CI: 0.11 to 0.40)]. The intervention group was not superior with regard to glycaemic control, diabetes self-management and diabetes acceptance. CONCLUSIONS: The trial indicates that Internet-based guided self-help treatments for depression in people with diabetes can have sustained effects on depressive symptoms, well-being and emotional distress associated with diabetes.

Effectiveness and cost-effectiveness of a guided Internet- and mobile-based intervention for the indicated prevention of major depression in patients with chronic back pain-study protocol of the PROD-BP multicenter pragmatic RCT.

BACKGROUND: Reducing the disease burden of major depressive disorder (MDD) is of major public health relevance. The prevention of depression is regarded as one possible approach to reach this goal. People with multiple risk factors for MDD such as chronic back pain and subthreshold depressive symptoms may benefit most from preventive measures. The Internet as intervention setting allows for scaling up preventive interventions on a public mental health level. METHODS: This study is a multicenter pragmatic randomized controlled trial (RCT) of parallel design aiming to investigate the (cost-) effectiveness of an Internet- and mobile-based intervention (IMI) for the prevention of depression in chronic back pain patients (PROD-BP) with subthreshold depressive symptoms. eSano BackCare-DP is a guided, chronic back pain-specific depression prevention intervention based on cognitive behavioral therapy (CBT) principles comprising six weekly plus three optional modules and two booster sessions after completion of the intervention. Trained psychologists provide guidance by sending feedback messages after each module. A total of 406 patients with chronic back pain and without a depressive disorder at baseline will be recruited following orthopedic rehabilitation care and allocated to either intervention or treatment-as-usual (TAU). Primary patient-relevant endpoint of the trial is the time to onset of MDD measured by the telephone-administered Structured Clinical Interview for DSM (SCID) at baseline and 1-year post-randomization. Key secondary outcomes are health-related quality of life, depression severity, pain intensity, pain-related disability, ability to work, intervention satisfaction and adherence as well as side effects of the intervention. Online assessments take place at baseline and 9 weeks as well as 6 and 12 months post-randomization. Cox regression survival analysis will be conducted to estimate hazard ratio at 12-month follow-up. Moreover, an economic analysis will be conducted from a societal and public health perspective. DISCUSSION: This is the first study examining an IMI for depression prevention in a sample of chronic pain patients. If this implementation of a depression prevention IMI into orthopedic aftercare proves effective, the intervention could be integrated into routine care with minimal costs and extended for use with other chronic diseases. Results will have implications for researchers, health care providers and public health policy makers. TRIAL REGISTRATION: The trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (DRKS): DRKS00007960 . Registered 12 August 2015.

[Screening for Anxiety in Cardiovascular Rehabilitation Patients: Concurrent Validity and Cut-off Values of the ACAT-cardio]. / Angst-Screening bei kardiologischen Rehabilitanden: Übereinstimmungsvalidität und Cut-Off-Werte des ACAT-cardio.

OBJECTIVE: The computer adaptive test ACAT-cardio has been developed in order to screen cardiovascular rehabilitation patients for anxiety. This study aims at investigating the criterion validity, and identifying appropriate cut-off values for its use in cardiac rehabilitation. METHODS: 106 cardiovascular rehabilitation patients were tested for anxiety disorders using the instruments ACAT-cardio and SKID-I. Receiver operating characteristics were employed to analyse the results of 3 stopping rules of the ACAT-cardio. RESULTS: ROC analyses for the stopping rules yielded areas under the curve (AUC) between 0.80 and 0.84. The ideal cut-off values of the ACAT-cardio (theta scores) were - 0.20 (sensitivity: 86%),-0.23 (sensitivity: 71%) and - 0.35 (sensitivity: 86%). CONCLUSIONS: The ACAT-cardio has proven to be a valid instrument that can be used for screening anxiety disorders in cardiac rehabilitation.

Panic disorder and incident coronary heart disease: a systematic review and meta-regression in 1131612 persons and 58111 cardiac events.

BACKGROUND: Substantial healthcare resources are devoted to panic disorder (PD) and coronary heart disease (CHD); however, the association between these conditions remains controversial. Our objective was to conduct a systematic review of studies assessing the association between PD, related syndromes, and incident CHD. METHOD: Relevant studies were retrieved from Medline, EMBASE, SCOPUS and PsycINFO without restrictions from inception to January 2015 supplemented with hand-searching. We included studies that reported hazard ratios (HR) or sufficient data to calculate the risk ratio and 95% confidence interval (CI) which were pooled using a random-effects model. Studies utilizing self-reported CHD were ineligible. Twelve studies were included comprising 1 131 612 persons and 58 111 incident CHD cases. RESULTS: PD was associated with the primary incident CHD endpoint [adjusted HR (aHR) 1.47, 95% CI 1.24-1.74, p < 0.00001] even after excluding angina (aHR 1.49, 95% CI 1.22-1.81, p < 0.00001). High to moderate quality evidence suggested an association with incident major adverse cardiac events (MACE; aHR 1.40, 95% CI 1.16-1.69, p = 0.0004) and myocardial infarction (aHR 1.36, 95% CI 1.12-1.66, p = 0.002). The risk for CHD was significant after excluding depression (aHR 1.64, 95% CI 1.45-1.85) and after depression adjustment (aHR 1.38, 95% CI 1.03-1.87). Age, sex, length of follow-up, socioeconomic status and diabetes were sources of heterogeneity in the primary endpoint. CONCLUSIONS: Meta-analysis showed that PD was independently associated with incident CHD, myocardial infarction and MACE; however, reverse causality cannot be ruled out and there was evidence of heterogeneity.

Psychological and pharmacological interventions for depression in patients with diabetes mellitus: an abridged Cochrane review.

AIMS: To summarize and critically evaluate the effectiveness of psychological and pharmacological interventions for depression in patients with both diabetes and depression. METHODS: Randomized controlled trials investigating psychological and pharmacological interventions for depression in adults with diabetes and depression were included. A comprehensive search of primary studies according to Cochrane were conducted. Primary outcomes were depression and glycaemic control. Further, treatment adherence, diabetes complications, mortality, healthcare costs and quality of life were investigated. Two reviewers identified primary studies and extracted data independently. Random-effects model meta-analyses were conducted to compute overall estimates of treatment outcomes. RESULTS: The database search resulted in 3963 references, of which 19 trials were included. Randomized controlled trials of psychological interventions showed positive effects on short- and medium-term depression severity [standardized mean difference short-term range -1.47; -0.14, n = 7; medium-term standardized mean difference -0.42 (95% CI -0.70 to -0.14), n = 3] and depression remission [odds ratio short term 2.88 (95% CI 1.58-5.25), n = 4; odds ratio medium term 2.49 (95% CI 1.44-4.32), n = 2]. Effects on glycaemic control in psychological intervention trials varied substantially (standardized mean difference range -0.97 to 0.47, n = 4). Selective serotonin reuptake inhibitors showed a moderate beneficial effect on short-term depression severity [standardized mean difference -0.39 (95% CI -0.64 to -0.13], n = 5) and depression remission [odds ratio 2.52 (95% CI 1.11-5.75), n = 2]. Glycaemic control improved in randomized controlled trials comparing selective serotonin reuptake inhibitors with placebo at the end of treatment [standardized mean difference -0.38 (95% CI -0.64 to -0.12), n = 5]. CONCLUSIONS: Psychological and pharmacological interventions positively affect depression outcomes in patients with diabetes at the end of treatment. Furthermore, short-term glycaemic control improved moderately in pharmacological trials. Most outcomes have not been investigated sufficiently. Moreover, there is a lack of follow-up data for pharmacological trials limiting the evidence on the sustainability of treatment effects.

[Intention to use and use of treatment due to psychological distress of patients in somatic rehabilitation]. / Inanspruchnahmebereitschaft und Inanspruchnahmeverhalten von Behandlungen aufgrund psychischer Belastungen bei Patienten der somatischen Rehabilitation.

BACKGROUND AND OBJECTIVES: Somatically ill patients in somatic rehabilitation often show comorbid psychological distress and mental disorders. In the framework of the implementation of a stepwise psychodiagnostic procedure, the present study investigated the intention to use and the use of treatment due to psychological distress. METHODOLOGY: Cohort study with a 6-months follow-up in 5 orthopedic, cardiologic and oncologic inpatient rehabilitation clinics (n=1 374). Psychological distress, sociodemographic data, intention to use psychotherapeutic or psychiatric treatments and the use of health care offers due to psychological distress were assessed by means of questionnaires. RESULTS: Every third patient (34%) was psychologically distressed at the beginning of rehabilitation. A positive intention to use psychotherapeutic or psychiatric treatment was reported by 79% of the psychologically distressed patients. 6 months after the end of rehabilitation, 26% of the patients who were psychologically distressed at the beginning of rehabilitation, had received treatment for mental health reasons. Reasons for non-utilization of treatment included lack of subjective need (45%) and lack of interest in treatment despite a perceived need (30%). Further 25% were considering treatment or were seeking appropriate treatment. CONCLUSIONS: Psychologically distressed rehabilitation patients show a high intention to undergo treatment. However, they show a clearly diminished use of post-rehabilitative treatments due to mental health problems. Hence, the promotion of motivation as well as the management of treatment barriers for improving post-rehabilitative use in psychologically distressed rehabilitants are of particular importance.

[Effectiveness of web-based psychological interventions for weight loss--a systematic review]. / Wirksamkeit web-basierter psychologischer Interventionen zur Gewichtsreduktion--ein systematisches Review.

Weight reduction is a core objective in the rehabilitation of somatic diseases. This systematic review aims to investigate the effectiveness of web-based psychological interventions for weight loss.Included were randomized controlled trials comparing web-based psychological interventions for weight loss with waiting list or usual care. Outcomes were body mass index (BMI), weight and waist circumference. Effect sizes were analyzed in random-effects meta-analyses.The search identified 5 trials. Subjects of the intervention group reduced their BMI (weighted mean difference--WMD = -0.49 [95%--CI: -0.95; -0.03]), weight (WMD = -1.32 [-2.59; -0.06]) and waist circumference (WMD = -2.35 [-3.18; -1.52]) significantly more than controls.Web-based psychological interventions are effective weight loss interventions. However, the effects are small and their clinical importance is limited.

[Internet based cognitive behavioral interventions: state of the art and implementation possibilities in rehabilitation]. / Internetbasierte kognitiv-behaviorale Behandlungs-ansätze: State of the Art und Einsatzmöglichkeiten in der Rehabilitation.

Internet-based health interventions (IHIs) provide a way to treat people via the Internet. The spectrum is wide, comprising interventions for mental disorders and somatic diseases as well as health and risk behavior change interventions. Numerous international studies have demonstrated the efficacy of IHIs for the aforementioned areas. Through the resource-saving applications IHIs are cost-efficient, not least suggesting their usefulness for medical rehabilitation. The present overview starts with a description of IHIs with a differentiation of technical-formal and thematic aspects. In doing so, the focus lies primarily on cognitive-behavioral treatment approaches, as the best scientifically investigated IHIs to date. An overview of the empirical evidence of IHIs is given, followed by a discussion of the implementation possibilities in medical rehabilitation.

[Examination of calibrated item banks for the assessment of work capacity in an outpatient sample of cardiological patients]. / Überprüfung kalibrierter Itembanken zur Erfassung der beruflichen Funktionsfähigkeit an einer Stichprobe ambulanter kardiologischer Rehabilitanden.

BACKGROUND: Work capacity is a major outcome variable in cardiological rehabilitation. However, there is a lacks of capacious and economic assessment instruments for work capacity. By developing item response theory based item banks a first step to close this gap is done. The present study aims to validate the work capacity item banks for cardiovascular rehabilitation inpatients (WCIB-Cardio) in a sample of cardiovascular rehabilitation outpatients. Additionally, we examined differences between in- and outpatients with regard to their work capacity. METHODS: Data of 283 cardiovascular rehabilitation inpatients and 77 cardiovascular rehabilitation outpatients were collected in 15 rehabilitation centres. The WCIB-Cardio contains the 2 domains of "cognitive work capacity"(20 items) and "physical work capacity"(18 items). Validation of the item bank for cardiological outpatients was conducted with separate Rasch analysis for each domain. RESULTS: For the domain of cognitive work capacity 10 items showed satisfying quality criteria (Rasch reliability=0.71; overall model fit=0.07). For the domain of physical work capacity good values for Rasch-reliability (0.83) and overall -model fit (0.65) could be proven after exclusion of 3 items. Unidimensionality and a broad ability spectrum could be covered for both domains. With regard to content, outpatients evaluate themselves less burdened than inpatients for the domain of cognitive work capacity (‾X outpatient =-2.06 vs. ‾X inpatient =-2.49; p<0.07) similarly for the domain of physical work capacity (‾X outpatient =-3.68 vs. ‾X inpatient =-2.88; p<0.01). DISCUSSION: With the WCIB-Cardio II there is a precondition to develop self-report instruments of work capacity in cardiological in- and outpatients.

StudiCare procrastination - Randomized controlled non-inferiority trial of a persuasive design-optimized internet- and mobile-based intervention with digital coach targeting procrastination in college students.

BACKGROUND: Academic procrastination is widespread among college students. Procrastination is strongly negatively correlated with psychological well-being, thus early interventions are needed. Internet- and mobile-based cognitive behavioral therapy (iCBT) could provide a low-threshold treatment option. Human guidance seems to be a decisive mechanism of change in iCBT. Persuasive design optimization of iCBT and guidance by a digital coach might represent a resource-saving alternative. The study evaluated the non-inferiority of a digital coach in comparison to human guidance with regard to the primary outcome procrastination. METHODS: The iCBT StudiCare procrastination was optimized by principles of the Persuasive System Design (PSD). A total of 233 college students were randomly assigned to either StudiCare procrastination guided by a digital coach (intervention group, IG) or by a human eCoach (control group, CG). All participants were assessed at baseline, 4-, 8- and 12-weeks post-randomization. Symptom change and between-group differences were assessed with latent growth curve models and supported by effect size levels. The non-inferiority margin was set at Cohen's d = - 0.3. RESULTS: The primary outcome procrastination measured by the Irrational Procrastination scale (IPS) significantly decreased across groups (γ = - 0.79, p < .001, Cohen's d = -0.43 to -0.89) from baseline to 12-weeks post-randomization. There were no significant differences between groups (γ = -0.03, p = .84, Cohen's d = -0.03 to 0.08). Regarding symptoms of depression, no significant time x group effect was found (γ = 0.26, p = .09; Cohen's d = -0.15 to 0.21). There was also no significant time x group effect on the improvement of symptoms of anxiety (γ = 0.25, p = .09). However, Cohen's ds were above the non-inferiority margin 8-weeks (Cohen's d = 0.51) and 12-weeks post-randomization (Cohen's d = 0.37), preferring the CG. Of the IG, 34% and of the CG, 36% completed 80% of the modules. CONCLUSIONS: The PSD optimized version of StudiCare procrastination is effective in reducing procrastination. The digital coach was not inferior to human guidance. Guidance by a digital coach in iCBT against procrastination for college students could be a resource-saving alternative to human guidance. TRIAL REGISTRATION: The trial was registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trial Register (ID: DRKS00025209, 30/04/2021).

A (Sub)field Guide to Quality Control in Hippocampal Subfield Segmentation on Highresolution T2-weighted MRI.

Inquiries into properties of brain structure and function have progressed due to developments in magnetic resonance imaging (MRI). To sustain progress in investigating and quantifying neuroanatomical details in vivo, the reliability and validity of brain measurements are paramount. Quality control (QC) is a set of procedures for mitigating errors and ensuring the validity and reliability of brain measurements. Despite its importance, there is little guidance on best QC practices and reporting procedures. The study of hippocampal subfields in vivo is a critical case for QC because of their small size, inter-dependent boundary definitions, and common artifacts in the MRI data used for subfield measurements. We addressed this gap by surveying the broader scientific community studying hippocampal subfields on their views and approaches to QC. We received responses from 37 investigators spanning 10 countries, covering different career stages, and studying both healthy and pathological development and aging. In this sample, 81% of researchers considered QC to be very important or important, and 19% viewed it as fairly important. Despite this, only 46% of researchers reported on their QC processes in prior publications. In many instances, lack of reporting appeared due to ambiguous guidance on relevant details and guidance for reporting, rather than absence of QC. Here, we provide recommendations for correcting errors to maximize reliability and minimize bias. We also summarize threats to segmentation accuracy, review common QC methods, and make recommendations for best practices and reporting in publications. Implementing the recommended QC practices will collectively improve inferences to the larger population, as well as have implications for clinical practice and public health.

[Transfer of research findings into medical practice]. / Transfer von Forschungsergebnissen in die medizinische Praxis.

AIM: Description of central factors for a successful implementation of research findings into practice. METHODOLOGY: A comprehensive literature search on "research transfer" was undertaken in the databases PSYNDEX, PsycINFO, MEDLINE, CINHAHL and EBMR for the years 1980-2009. RESULTS: The transfer process is influenced by a variety of factors across four levels: Level 1) the implementation strategy, 2) the individual, 3) the organisation as well as 4) the society, respectively, the politics. The factors and levels interact with one other. A detailed description of each factor is provided. CONCLUSION: For optimal patient care, the timely transfer of research findings on the effectiveness of interventions and measures into clinical practice is of central importance. To advance this process, research and practice should be increasingly interlinked with each other. The consideration of the factors referred to in the present review increase the likelihood of a successful implementation.

[Documentation of comorbid mental disorders in medical rehabilitation: an analysis of discharge reports]. / Dokumentation komorbider psychischer Störungen in der medizinischen Rehabilitation: Eine Analyse ärztlicher Entlassungsberichte.

OBJECTIVES: Patients with chronic somatic -diseases often suffer from psychological distress and mental disorders, which remain unrecognized in somatic rehabilitation. The present -study aimed to investigate whether the implementation of a stepwise psychodiagnostic procedure improves the documentation of psychological distress and mental disorders as well as of the -related inpatient treatments and aftercare recommendations. METHODOLOGY: Implementation of a stepwise psychodiagnostic procedure in 5 orthopaedic, cardiologic and oncologic inpatient rehabilitation clinics. The 4 steps comprised (1) screening, (2) in-depth psychodiagnostic assessment, (3) diagnosis and treatment, (4) documentation. Implementation efficacy in terms of a better documentation was evaluated by comparing the discharge reports of every fifth screening-positive and screening-negative patient (n=146) with historical discharge reports of the last 3 months preceding baseline assessment (n=161). RESULTS: Mental disorders (26,0% vs. 21,7%), general psychological treatment (75,3% vs. 66,5%), specific psychological treatment (32,9% vs. 31,7%), as well as psychologically relevant aftercare recommendations (41,1% vs. 34,8%) were more frequently documented in the current post-implementation discharge reports compared to the historical discharge reports. A significant difference was found only for the documentation of general psychological treatment. CONCLUSION: The results suggest that the implementation of a stepwise psychodiagnostic procedure improves the documentation of psychological distress and mental disorders as well as related inpatient treatments and aftercare recommendations. Continuous staff training and quality assurance relative to the discharge reports may contribute to further enhancing the documentation of psychological distress and mental disorders.

Standardized evaluation of the quality and persuasiveness of mobile health applications for diabetes management.

This study evaluates diabetes self-management mobile health applications available from European app stores with respect to quality, concordance with recommended self-management tasks and implementation of persuasive system design principles. The European Play Store and Apple App Store were systematically searched and relevant apps were tested. Two raters independently assessed app quality using the Mobile Application Rating Scale and conducted a content analysis of provided persuasive system design principles and self-management tasks. A total of 2,269 mobile health applications were identified and 120 could be included in the evaluation. The overall quality was rated as moderate M = 3.20 (SD = 0.39, min = 2.31, max = 4.62), with shortcomings in the subcategories of engagement (M = 2.80, SD = 0.67) and information quality (M = 2.26, SD = 0.48). Scientific evidence is available for 8% of the apps. The reviewed apps implemented a median of three persuasive system design principles (range 0-15) and targeted a median of 4.5 (range 1-8) self-management tasks, however, with a lack of information about psychosocial coping strategies. Most available diabetes self-management apps lack a scientific evidence base. Persuasive system design features are underrepresented and may form a promising tool to improve app quality. Furthermore, the interaction of physical and behavioral health should be improved in existing diabetes self-management mobile health applications.

Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors.

BACKGROUND: The phase I GATTO study (NCT03360734) explored the feasibility, tolerability and preliminary activity of combining gatipotuzumab, a novel humanized monoclonal antibody binding to the tumor-associated epitope of mucin 1 (TA-MUC1) and an anti-epidermal growth factor receptor (anti-EGFR) antibody in refractory solid tumors. PATIENTS AND METHODS: Initially the study enrolled primary phase (PP) patients with EGFR-positive metastatic solid tumors, for whom no standard treatment was available. Patients received gatipotuzumab administered at 1400 mg every 2 weeks, 6 weeks after the start of the glyco-optimized anti-EGFR antibody tomuzotuximab at 1200 mg every 2 weeks. As this regimen was proven safe, enrollment continued in an expansion phase (EP) of patients with refractory metastatic colorectal cancer, non-small-cell lung cancer, head and neck cancer and breast cancer. Tomuzotuximab and gatipotuzumab were given at the same doses and gatipotuzumab treatment started 1 week after the first dose of the anti-EGFR antibody. Additionally, investigators could use a commercial anti-EGFR antibody in place of tomuzotuximab. RESULTS: A total of 52 patients were enrolled, 20 in the PP and 32 in the EP. The combined treatment was well tolerated and no dose-limiting toxicity was observed in the whole study, nor related serious adverse event or death. Preliminary activity of the combination was observed, with one and four RECIST partial responses in the PP and EP, all in colorectal cancer patients. The trial was accompanied by a comprehensive translational research program for identification of biomarkers, including soluble TA-MUC1 (sTA-MUC1) in serum. In the EP, patients with baseline sTA-MUC1 levels above the median appeared to have improved progression-free survival and overall survival. CONCLUSIONS: Combination of a TA-MUC1-targeting antibody and an EGFR-targeting antibody is safe and feasible. Interesting antitumor activity was observed in heavily pretreated patients. Future studies should test this combination together with chemotherapy and explore the potential of sTA-MUC1 as a companion biomarker for further development of the combination.

Maintenance therapy of patients with recurrent epithelial ovarian carcinoma with the anti-tumor-associated-mucin-1 antibody gatipotuzumab: results from a double-blind, placebo-controlled, randomized, phase II study.

BACKGROUND: Gatipotuzumab is a humanized monoclonal antibody recognizing the carbohydrate-induced epitope of the tumor-associated mucin-1 (TA-MUC1). This study aimed to evaluate the efficacy and safety of switch maintenance therapy with gatipotuzumab in patients with TA-MUC1-positive recurrent ovarian, fallopian tube, or primary high-grade serous peritoneal cancer. PATIENTS AND METHODS: In this double-blind, randomized, placebo-controlled, phase II trial, patients with at least stable disease (SD) following chemotherapy were randomized 2:1 to receive intravenous gatipotuzumab (500 mg followed by 1700 mg 1 week later) or placebo every 3 weeks until tumor progression or unacceptable toxicity occurred. Stratification factors were the number of prior chemotherapy lines (2 versus 3-5), response versus SD after the most recent chemotherapy, and progression-free survival (PFS) <6 versus 6-12 months following the prior therapy. Primary endpoint was PFS according to modified immune-related RECIST 1.1 response criteria. Secondary endpoints were PFS at 6 months, safety, overall response rate, CA-125 progression, overall survival, quality of life, and pharmacokinetics. RESULTS: Overall, 216 patients were randomized to gatipotuzumab (n  = 151) or placebo (n  = 65). Median PFS with gatipotuzumab was 3.5 months as compared with 3.5 months with placebo (hazard ratio 0.96, 95% confidence interval 0.69-1.33, P  = 0.80). No advantage for gatipotuzumab over placebo was seen in the secondary efficacy endpoints or in any stratified subgroups. Gatipotuzumab was well tolerated, with mild to moderate infusion-related reactions being the most common adverse events. CONCLUSIONS: Gatipotuzumab switch maintenance therapy does not improve outcome in TA-MUC1-positive ovarian cancer patients. TRIAL REGISTRATION: ClinicalTrials.govNCT01899599; https://clinicaltrials.gov/ct2/show/NCT01899599.

[Psychological comorbidity in patients with musculoskeletal diseases]. / Psychische Komorbidität bei muskuloskelettalen Erkrankungen.

The present review summarizes the evidence on epidemiology, etiology, and treatment of comorbid mental disorders in patients with musculoskeletal diseases. Epidemiological studies highlight a significantly increased risk of comorbid mental disorders in patients with musculoskeletal diseases compared to patients without musculoskeletal diseases and physically healthy persons. With regard to the question of the causal link between these comorbidities, specific musculoskeletal disease-mental disorder combinations show specific pathogenetic pathways. Using the example of arthritis-depression comorbidity, a causality model is presented. This model describes depression as following arthritis and, in turn, aggravating the course of arthritis. Treatment studies emphasize the effectiveness of both psychotherapeutic and psychopharmacological interventions for the treatment of patients with musculoskeletal diseases and comorbid mental disorders. In particular, collaborative care interventions are promising approaches to improve the routine care of comorbid patients.