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Early investigations of subjective well-being responses to the COVID-19 pandemic indicated average deterioration but also high variability related to vulnerability of population groups and pandemic phase. Thus, we aimed to gain new insights into the characteristics of certain groups and their differences in subjective well-being response patterns over time. First, we performed Latent Class Analyses with baseline survey data of 2,137 adults (mean age = 40.98, SD = 13.62) derived from the German CORONA HEALTH APP Study to identify subgroups showing similarity of a comprehensive set of 50 risk and protective factors. Next, we investigated the course of quality of life (QoL) as an indicator of subjective well-being grouped by the identified latent classes from July 2020 to July 2021 based on monthly and pandemic phase averaged follow-up survey data by means of Linear Mixed-Effects Regression Modeling. We identified 4 latent classes with distinct indicators and QoL trajectories (resilient, recovering, delayed, chronic) similar to previous evidence on responses to stressful life events. About 2 out of 5 people showed a resilient (i.e., relative stability) or recovering pattern (i.e., approaching pre-pandemic levels) over time. Absence of depressive symptoms, distress, needs or unhealthy behaviors and presence of adaptive coping, openness, good family climate and positive social experience were indicative of a resilient response pattern during the COVID-19 pandemic. The presented results add knowledge on how to adapt and enhance preparedness to future pandemic situations or similar societal crises by promoting adaptive coping, positive thinking and solidary strategies or timely low-threshold support offers.

The high global prevalence of depression, together with the recent acceleration of remote care owing to the COVID-19 pandemic, has prompted increased interest in the efficacy of digital interventions for the treatment of depression. We provide a summary of the latest evidence base for digital interventions in the treatment of depression based on the largest study sample to date. A systematic literature search identified 83 studies (N = 15,530) that randomly allocated participants to a digital intervention for depression versus an active or inactive control condition. Overall heterogeneity was very high (I2 = 84%). Using a random-effects multilevel metaregression model, we found a significant medium overall effect size of digital interventions compared with all control conditions (g = .52). Subgroup analyses revealed significant differences between interventions and different control conditions (WLC: g = .70; attention: g = .36; TAU: g = .31), significantly higher effect sizes in interventions that involved human therapeutic guidance (g = .63) compared with self-help interventions (g = .34), and significantly lower effect sizes for effectiveness trials (g = .30) compared with efficacy trials (g = .59). We found no significant difference in outcomes between smartphone-based apps and computer- and Internet-based interventions and no significant difference between human-guided digital interventions and face-to-face psychotherapy for depression, although the number of studies in both comparisons was low. Findings from the current meta-analysis provide evidence for the efficacy and effectiveness of digital interventions for the treatment of depression for a variety of populations. However, reported effect sizes may be exaggerated because of publication bias, and compliance with digital interventions outside of highly controlled settings remains a significant challenge. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Obgleich die Wirksamkeit internet- und „mobile“-basierter Interventionen fur verschiedene psychische Storungen zwischenzeitlich als gut belegt anzusehen ist, existiert bislang wenig gesichertes Wissen zu spezifischen Wirkungsweisen digitaler Psychotherapie. Im vorliegenden Beitrag werden zunachst zentrale Begriffe und Methoden der Psychotherapieprozessforschung erortert (u. a. allgemeine und spezifische Wirkfaktoren, Komponentenstudien, Mediatoren und Veranderungsmechanismen), um darauf aufbauend ein integratives psychologisches Modell uber die moglichen Wirkungsweisen digitaler Psychotherapie vorzustellen. Die einzelnen Bestandteile des Modells werden anhand der empirischen Evidenz beispielhaft zu depressiven Storungen diskutiert, mit einem Ausblick hinsichtlich zentraler Forschungsdesiderate.

Versorgungsforschung im Feld der seelischen Gesundheit ist von zunehmender Bedeutung. Angesichts dieser Entwicklung hat die im Oktober 2017 gegrundete DNVF Fachgruppe „Seelische Gesundheit“ ein Diskussionspapier verfasst, welches zentrale Besonderheiten, Herausforderungen und Ziele der Versorgungsforschung im Bereich der seelischen Gesundheit zusammenfasst. Im Einzelnen werden forschungsrelevante Besonderheiten des Versorgungsfeldes, pragmatische Probleme bei der Forschungsorganisation, ethische Herausforderungen und fur dieses Feld besondere Themenstellungen vorgestellt und diskutiert.

Within the healthcare environment, mobile health (mHealth) applications (apps) are becoming more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the COVID-19 pandemic has led to an enormous amount of app releases. In most countries, mHealth applications have to be compliant with several regulatory aspects to be declared a “medical app”. However, the latest applicable medical device regulation (MDR) does not provide more details on the requirements for mHealth applications. When developing a medical app, it is essential that all contributors in an interdisciplinary team—especially software engineers—are aware of the specific regulatory requirements beforehand. The development process, however, should not be stalled due to integration of the MDR. Therefore, a developing framework that includes these aspects is required to facilitate a reliable and quick development process. The paper at hand introduces the creation of such a framework on the basis of the Corona Health and Corona Check apps. The relevant regulatory guidelines are listed and summarized as a guidance for medical app developments during the pandemic and beyond. In particular, the important stages and challenges faced that emerged during the entire development process are highlighted., publishedVersion

IntroductionThe integration of a web-based computer-adaptive patient-reported outcome test (CAT) platform with persuasive design optimised features including recommendations for action into routine healthcare could provide a promising way to translate reliable diagnostic results into action. This study aims to evaluate the effectiveness and cost-effectiveness of such a platform for depression and anxiety (RehaCAT+) compared with the standard diagnostic system (RehaCAT) in cardiological and orthopaedic health clinics in routine care.Methods and analysisA two-arm, pragmatic, cluster-randomised controlled trial will be conducted. Twelve participating rehabilitation clinics in Germany will be randomly assigned to a control (RehaCAT) or experimental group (RehaCAT+) in a 1:1 design. A total sample of 1848 participants will be recruited across all clinics. The primary outcome, depression severity at 12 months follow-up (T3), will be assessed using the CAT Patient-Reported Outcome Measurement Information System Emotional Distress-Depression Item set. Secondary outcomes are depression at discharge (T1) and 6 months follow-up (T2) as well as anxiety, satisfaction with participation in social roles and activities, pain impairment, fatigue, sleep, health-related quality of life, self-efficacy, physical functioning, alcohol, personality and health economic-specific general quality of life and socioeconomic cost and benefits at T1-3. User behaviour, acceptance, facilitating and hindering factors will be assessed with semistructured qualitative interviews. Additionally, a smart sensing substudy will be conducted, with daily ecological momentary assessments and passive collection of smartphone usage variables. Data analysis will follow the intention-to-treat principle with additional per-protocol analyses. Cost-effectiveness analyses will be conducted from a societal perspective and the perspective of the statutory pension insurance.Ethics and disseminationThe study will be conducted according to the Declaration of Helsinki. The Ethics Committee of Ulm University, has approved the study (on 24 February 2021 ref. 509/20). Written informed consent will be obtained for all participants. Results will be published via peer-reviewed journals.Trial registration numberDRKS00027447

Introduction: Evidence on effects of Internet-based interventions to treat subthreshold depression (sD) and prevent the onset of major depression (MDD) is inconsistent. Objective: We conducted an individual participant data meta-analysis to determine differences between intervention and control groups (IG, CG) in depressive symptom severity (DSS), treatment response, close to symptom-free status, symptom deterioration and MDD onset as well as moderators of intervention outcomes. Methods: Randomized controlled trials were identified through systematic searches via PubMed, PsycINFO, Embase and Cochrane Library. Multilevel regression analyses were used to examine efficacy and moderators. Results: Seven trials (2,186 participants) were included. The IG was superior in DSS at all measurement points (posttreatment: 6–12 weeks; Hedges’ g = 0.39 [95% CI: 0.25–0.53]; follow-up 1: 3–6 months; g = 0.30 [95% CI: 0.15–0.45]; follow-up 2: 12 months, g = 0.27 [95% CI: 0.07–0.47], compared with the CG. Significantly more participants in the IG than in the CG reached response and close to symptom-free status at all measurement points. A significant difference in symptom deterioration between the groups was found at the posttreatment assessment and follow-up 2. Incidence rates for MDD onset within 12 months were lower in the IG (19%) than in the CG (26%). Higher initial DSS and older age were identified as moderators of intervention effect on DSS. Conclusions: Our findings provide evidence for Internet-based interventions to be a suitable low-threshold intervention to treat individuals with sD and to reduce the incidence of MDD. This might be particularly true for older people with a substantial symptom burden.

OBJECTIVE To analyze the independent associations of depression and diabetes distress with self-management and glycemic outcome in Type I (T1DM) and Type 2 diabetes (T2DM). METHOD Six hundred six people with T1DM or T2DM participated in a cross-sectional survey including measures of depression (PHQ-9), diabetes distress (PAID-5), self-management behavior (DSMQ), and glycemic outcome (HbA1c). Structural equation modeling was performed to analyze the independent linear associations (standardized coefficients) between these variables. RESULTS In those with T1DM (n = 339), both depressive symptoms and diabetes distress were associated with lower self-management (-0.34, p < .001, and -0.16, p = .007, respectively) and thereover (indirectly) with higher HbA1c (0.20, p < .001, and 0.10, p = .016, respectively); direct associations with HbA1c were not observed. In those with T2DM (n = 267), only depressive symptoms were associated with lower self-management (-0.41, p < .001) and thus (indirectly) with higher HbA1c (0.17, p < .001). Diabetes distress, by contrast, was directly associated with higher HbA1c (0.20, p = .003) but not with self-management. CONCLUSIONS The results are consistent with the hypothesis that depression is linked to less optimal diabetes self-management, thus leading to less optimal glycemic outcome. The associations were relatively consistent across diabetes types. Diabetes distress was additionally associated with higher glycemic levels, suggesting that people with both depression and diabetes distress might have the least optimal outcome. The conclusions are limited by the cross-sectional study design, self-report assessment of behavior, and potential bias arising from questionnaire measures. Further research is needed to support these findings. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

The efficacy of Internet- and mobile-based interventions (IMIs) for depression in adults is well established. Yet, comprehensive knowledge on the mediators responsible for therapeutic change in these interventions is pending. Therefore, we conducted the first systematic review on mediators in IMIs for depression, investigating mechanisms of change in interventions with different theoretical backgrounds and delivery modes (PROSPERO CRD42019130301). Two independent reviewers screened references from five databases (i.e., Cochrane Library, Embase, MEDLINE/PubMed, PsycINFO and ICTRP), selected studies for inclusion and extracted data from eligible studies. We included 26 RCTs on mediators in IMIs for depression (6820 participants), rated their risk of bias and adherence to methodological quality criteria for psychotherapy process research. Primary studies examined 64 mediators, with cognitive variables (e.g., perceived control, rumination or interpretation bias) being the largest group of both examined (m = 28) and significant mediators (m = 22); followed by a range of other mediators, including mindfulness, acceptance and behavioral activation. Our findings might contribute to the empirically-informed advancement of interventions and mental health care practices, enabling optimized treatment outcomes for patients with depression. Furthermore, we discuss implications for future research and provide methodological recommendations for forthcoming mediation studies with more pertinent designs, allowing for inferences with higher causal specificity.

Mental health problems are becoming more common while access to treatment is often not available to everyone who needs help. Recent advances in information technology, the wide availability of the internet, the emergence of smartphones and their common usage worldwide raise hope for more treatment options for mental health disorders. Many mobile phone apps that claim to assist in treating a variety of mental health disorders are already available, and the number of such apps continues to increase. The availability of such apps raises many questions about their effectiveness, suitable treatment methods, possibilities for use alongside traditional treatment methods, possible risks and other uncertainties. Beside mobile apps, internet-based apps are also being introduced with similar sets of challenges and ambiguities. One area of research that is gaining a lot of attention recently is Persuasive System Design and Behavior Change. Persuasive System Design is considered one solution that has the potential to help solve the challenges of lack of user motivation and adherence when utilizing mental health applications. The goal of this paper is to perform a literature review, in order to determine the most essential requirements for a persuasively designed mental health application. As part of this process, the challenges and requests of the end-user will be taken into account in order to make recommendations for the future design of such applications.

Digital phenotyping represents a new powerful tool to implement psychodiagnostics in many areas of psychology and medicine. The basic idea behind digital phenotyping is that digital footprints of a person left on social media, smartphones, or other sources of the Internet of Things can be used to get fine grained insights into psychological trait and state variables. Although digital phenotyping has tremendous potential to shed new light on human nature, it naturally comes with risks in the domains of privacy. Therefore, the present article reflects on necessary prerequisites on societal, scientific, and individual level to reduce harm and increase benefits of digital phenotyping.

A large number of mobile health applications claiming to target insomnia are available in commercial app stores. However, limited information on the quality of these mobile health applications exists. The present study aimed to systematically search the European Google Play and Apple App Store for mobile health applications targeting insomnia, and evaluate the quality, content, evidence base and potential therapeutic benefit. Eligible mobile health applications were evaluated by two independent reviewers using the Mobile Application Rating Scale-German, which ranges from 1 – inadequate to 5 – excellent. Of 2236 identified mobile health applications, 53 were included in this study. Most mobile health applications (68%) had a moderate overall quality. Concerning the four main subscales of the Mobile Application Rating Scale-German, functionality was rated highest (M = 4.01, SD = 0.52), followed by information quality (M = 3.49, SD = 0.72), aesthetics (M = 3.31, SD = 1.04) and engagement (M = 3.02, SD = 1.03). While scientific evidence was identified for 10 mobile health applications (19%), only one study employed a randomized controlled design. Fifty mobile health applications featured sleep hygiene/psychoeducation (94%), 27 cognitive therapy (51%), 26 relaxation methods (49%), 24 stimulus control (45%), 16 sleep restriction (30%) and 24 sleep diaries (45%). Mobile health applications may have the potential to improve the care of insomnia. Yet, data on the effectiveness of mobile health applications are scarce, and this study indicates a large variance in the quality of the mobile health applications. Thus, independent information platforms are needed to provide healthcare seekers and providers with reliable information on the quality and content of mobile health applications., publishedVersion

Background Mindfulness-based interventions show positive effects on physical and mental health. For a better integration of mindfulness techniques in daily life, the use of apps may be promising. However, only a few studies have examined the quality of mindfulness apps using a validated standardized instrument. This review aims to evaluate the content, quality, and privacy features of mindfulness-focused apps from European commercial app stores. Methods An automated search engine (webcrawler) was used to identify mindfulness-focused apps in the European Apple App- and Google Play store. Content, quality, and privacy features were evaluated by two independent reviewers using the Mobile Application Rating Scale (MARS). The MARS assesses the subscales engagement, functionality, aesthetics, and information quality. Results Out of 605 identified apps, 192 met the inclusion criteria. The overall quality was moderate (M = 3.66, SD = 0.48). Seven apps were tested in a randomized controlled trial (RCT). Most of the apps showed a lack of data security and no privacy policy. The five apps with the highest ratings are from a credible source, include a privacy policy, and are also based on standardized mindfulness and behavior change techniques. Conclusions The plethora of often low-quality apps in commercial app stores makes it difficult for users to identify a suitable app. Above that, the lack of scientific verification of effectiveness and shortcomings in privacy protection and security poses potential risks. So far, the potential of mindfulness-focused apps is not exploited in commercial app stores., publishedVersion

Background There is no meta-analysis that specifically evaluates the effectiveness of Internet- and mobile-based interventions (IMIs) in adults with diagnosed panic disorder and/or agoraphobia (PD/A) so far. The current meta-analysis aims to fill this gap (PROSPERO CRD 42016034016). Methods Systematic literature searches in six databases for randomised and controlled clinical trials investigating IMIs in adults, who met diagnostic criteria for PD/A. Study selection and data extraction were conducted independently by two reviewers. Random-effects meta-analyses, pre-planned subgroup and sensitivity analyses were conducted when appropriate. Primary outcomes were PD and A symptom severity. In addition, adherence, response, remission, quality of life, anxiety and depression symptom severity were examined. Results A total of 16 trials (1015 patients), with 21 comparisons (9 IMI vs. waitlist; 7 IMI vs. IMI; 5 IMI vs. active treatment condition), were included. IMIs revealed beneficial effects on panic (Hedges’ g range −2.61 to −0.25) and agoraphobia symptom severity when compared to waitlist (pooled g = −1.15, [95%-CI = −1.56; −0.74]). Studies comparing IMIs to active controls (i.e., face-to-face CBT and applied relaxation) did not find significant differences for reductions in panic (g = −0.02, [95%-CI = −0.25; 0.21]) and agoraphobia symptom severity (g = −0.10, [95%-CI = −0.39; 0.19]). Furthermore, IMIs were superior to waitlist controls regarding anxiety and depression symptom severity and quality of life. Limitations Tests for publication bias were not feasible due to the limited number of trials per comparison, and the risk of bias assessment indicated some methodological shortcomings. Conclusions Findings from this meta-analytic review provide support for the effectiveness of IMIs in patients with verified PD/A. However, before IMIs can be included in treatment guidelines for PD/A, future high quality research is needed that substantiates and extends the evidence base, especially in regard to intervention safety.

ZusammenfassungJugendliche und junge Erwachsene mit Typ-1-Diabetes sind häufig von komorbiden psychischen Störungen betroffen. Dabei zeigt die Studienlage zur Verbreitung ein heterogenes und inkonsistentes Bild. Diagnose und Behandlung der somatopsychischen Begleiterkrankungen beeinflussen den Behandlungs- und Krankheitsverlauf sowie die Lebensqualität der Betroffenen. Trotzdem wird dies in der klinischen Praxis selten frühzeitig berücksichtigt. Das multizentrische Verbundprojekt COACH verfolgt das Ziel, die Erkennung und Behandlung psychischer Komorbidität für diese Zielgruppe in der bundesweiten Routineversorgung zu optimieren.

Digital offerings provide a multitude of possibilities for psychotherapeutic care and receive increasing attention in the media and on the part of therapists. Despite substantial evidence of efficacy, frequently voiced concerns interfere with their implementation. As the therapeutic relationship is almost unanimously considered to be the central factor determining the effectiveness of classical psychotherapy, one recurrent query concerns the extent to which such a relationship can be established via digital communication channels. Patients report that a resilient and positive work-related therapeutic relationship can indeed be established in digital therapy. Little is known about the degree to which the therapeutic relationship is an operative mechanism of change in digital interventions with minimal therapeutic contact. Specific varieties of communication and behaviour offer helpful support for therapists endeavouring to build up a good working relationship via digital channels. (PsycInfo Database Record (c) 2021 APA, all rights reserved) Abstract (German) Digitale Angebote bieten eine Vielzahl an Moglichkeiten zur psychotherapeutischen Versorgung und erfahren zunehmend mediale sowie therapeutenseitige Aufmerksamkeit. Trotz zahlreicher Wirksamkeitsnachweise stehen haufig geauserte Bedenken der Implementierung im Wege - v.a. die Frage, inwiefern auch uber digitale Kommunikationskanale eine therapeutische Beziehung aufgebaut werden kann, zumal diese als zentraler Wirkmechanismus der klassischen Psychotherapie gilt. Patient*innen berichten, dass sie es auch in digitalen Therapien erleben, dass eine tragfahige und positive arbeitsbezogene therapeutische Beziehung aufgebaut werden kann. Unklar bleibt, inwiefern die therapeutische Beziehung in Interventionen mit minimalem therapeutischen Kontakt zur Wirksamkeit beitragt. Spezifische Kommunikations- und Verhaltenshinweise bieten hilfreiche Unterstutzung, damit Therapeut*innen auch uber digitale Kommunikationskanale eine gute Arbeitsbeziehung aufbauen konnen. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Importance: Depression is a frequent comorbid condition in patients with persistent back pain and is associated with substantial adverse consequences, including the risk of developing opioid use disorders. Shifting the focus from depression treatment to preventing depression might be a viable way to reduce the disease burden. Objective: To evaluate the effectiveness of a web-based self-help intervention to reduce the incidence of major depressive episode (MDE) in patients with persistent back pain. Design, Setting, and Participants: Prevention of Depression in Back Pain Patients (PROD-BP) was a pragmatic, observer-blinded randomized clinical trial with a parallel design conducted in Germany. Eligible adults with a diagnosis of persistent back pain and subclinical depressive symptoms, but who were depression free, were recruited either on-site or after discharge from 82 orthopedic clinics between October 1, 2015, and July 31, 2017. All analyses were conducted according to the intention-to-treat principle from October 31, 2018, to April 30, 2019. Interventions: The intervention group received an e-coach-guided, web-based self-help intervention that was based on cognitive behavioral therapy and tailored to the needs of patients with persistent back pain. The intervention included 6 obligatory modules and 3 optional modules to be completed by participants as well as feedback from e-coaches. Both the intervention and control groups had unrestricted access to treatment as usual. Main Outcomes and Measures: Primary outcome was time to onset of an MDE over a 12-month period as assessed by blinded diagnostic raters using the Structured Clinical Interview for DSM-5. Secondary outcomes included depression severity, quality of life, pain intensity, pain-related disability, pain self-efficacy, work capacity, and user satisfaction assessed with a variety of instruments. Results: A total of 295 participants (mean [SD] age, 52.8 [7.7] years; 184 women [62.4%]) were recruited and randomized to either the intervention group (n = 149) or control group (n = 146). The intervention reduced the risk of MDE onset by 52% (hazard ratio, 0.48; 95% CI, 0.28-0.81; P

Purpose of review Internet and mobile-based interventions (IMI) can be used as online delivered forms of psychotherapeutic mental health treatments. These interventions can be an effective as well as time and cost-efficient treatment with the potential to scale up mental healthcare. In this review, we map implementation possibilities into routine mental healthcare settings and provide the most recent evidence. Recent findings Fourteen articles on digital mental healthcare approaches published in the last 18 months were included. Despite the limited number, the studies provide evidence for the effectiveness of IMI in treating inpatients and outpatients with various disorders in different mental healthcare settings. IMI were investigated as stand-alone interventions, in combination with other treatment forms (blended-care), or as aftercare. Summary Although there is encouraging evidence for the effectiveness of IMI in mental healthcare settings, several limitations have to be considered. The small number of studies conducted within the healthcare system, especially with inpatient samples, calls for more collaboration between researchers and clinical practitioners to unravel barriers and develop efficient protocols for the integration into routine care. Nonetheless, IMI are a promising tool for the endeavour of closing the treatment gap and should, therefore, be further explored in varying settings.

BackgroundPrevious studies show that university students experience higher psychological stress than the general population, resulting in increased vulnerability for mental disorders for the student population. Online mindfulness interventions will be delivered to students as a potentially promising and more flexible approach compared to face-to-face interventions with the aim of improving their mental health. This study purposes to investigate the effectiveness of a guided online mindfulness-focused intervention for university students by using both self-reported and psychobiological measures.Methods and analysesIn this multicentre, two-armed randomised controlled trial with a parallel design, a guided version of the online mindfulness-focused intervention ‘StudiCare Mindfulness’ will be compared with a waitlist control group. In total, 120 participants will be recruited at different universities (of Applied Sciences) in (Neu-) Ulm. Data will be assessed prior to randomisation, after eight weeks (post-intervention) and six months after randomisation (follow-up). The primary outcome measure is mindfulness. The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia. Psychobiological parameters comprise interoceptive accuracy, hair cortisol and FKBP5 genotype. Sociodemographic variables, treatment expectations, side and adverse side effects, as well as intervention satisfaction and adherence will be assessed. All data analyses will be conducted according to the intention-to-treat principle.Ethics and disseminationAll study procedures have been approved by the Ethics Committee of Ulm University (application No. 48/18). The findings will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration numberDRKS00014701.

Abstract. This meta-review integrates the current meta-analysis literature on the efficacy of internet- and mobile-based interventions (IMIs) for mental disorders and somatic diseases in children and adolescents. Further, it summarizes the moderators of treatment effects in this age group. Using a systematic literature search of PsycINFO and MEDLINE/PubMed, we identified eight meta-analyses (N = 8,417) that met all inclusion criteria. Current meta-analytical evidence of IMIs exists for depression (range of standardized mean differences, SMDs = .16 to .76; 95 % CI: –.12 to 1.12; k = 3 meta-analyses), anxiety (SMDs = .30 to 1.4; 95 % CI: –.53 to 2.44; k = 5) and chronic pain (SMD = .41; 95 % CI: .07 to .74; k = 1) with predominantly nonactive control conditions (waiting-list; placebo). The effect size for IMIs across mental disorders reported in one meta-analysis is SMD = 1.27 (95 % CI: .96 to 1.59; k = 1), the effect size of IMIs for different somatic conditions is SMD = .49 (95 % CI: .33 to .64; k = 1). Moderators of treatment effects are age (k = 3), symptom severity (k = 1), and source of outcome assessment (k = 1). Quality ratings with the AMSTAR-2-checklist indicate acceptable methodological rigor of meta-analyses included. Taken together, this meta-review suggests that IMIs are efficacious in some health conditions in youths, with evidence existing primarily for depression and anxiety so far. The findings point to the potential of IMIs to augment evidence based mental healthcare for children and adolescents.

The ubiquity of smart mobile devices facilitates data collection in the healthcare domain. Two of the concepts, which can be applied in this context, are mobile crowdsensing (MCS) and ecological momentary assessment (EMA). TrackYourTinnitus (TYT) is an advanced mobile healthcare platform that combines both concepts enabling the monitoring and evaluation of the users’ individual variability of tinnitus symptoms. This paper describes the underlying data set and structure of the TYT mobile platform and highlights selected issues whose investigation provides advanced insights into the users of this mobile platform as well as their data.

Partners of cancer patients are the primary supporters and burdened at the same time. Support for partners is hitherto scarce and existing offers are rarely used. The PartnerCARE online intervention was specifically developed to address the caregiving partners' needs. This two-arm parallel randomized controlled trial (RCT) evaluates the feasibility, acceptability, and potential efficacy of PartnerCARE.Sixty German-speaking partners of patients with various cancer entities were randomized into two conditions: intervention group (IG) with PartnerCARE (N = 30) or waitlist-control group (N = 30). Participants completed online questionnaires at baseline (T0), post-treatment (T1) and 4-months follow-up (T2). Feasibility and acceptability outcomes included dropout rates, use and acceptance of PartnerCARE, individual user/e-coach feedback as well as negative effects. Relevant efficacy outcomes were assessed to test for potential intervention effects.Recruitment success illustrates demand for and acceptability of PartnerCARE. Satisfaction with the intervention was high (Client Satisfaction Questionnaire adapted to Internet-based interventions, T1: M = 24.66, SD = 6.42) and 73.3% of participants completed the intervention. Study dropout rate was low (T1: 17%, T2: 29%). More positive than negative side effects of the intervention were identified, and negative ones were mainly related to "intrapersonal change". For efficacy outcomes we found effects over time, with strongest effects within the IG from T0 to T1 in psychological distress (d = 0.73, 95%-CI: [0.34; 1.12]) and anxiety (0.66, [0.26; 1.04]), but no group effects were significant at T1 and T2.PartnerCARE is feasible, acceptable and potentially efficacious. Based on received feedback, PartnerCARE is currently undergoing further development and subsequently efficacy will be investigated in a RCT.German Clinical Trial Registration: DRKS00017019. Registered on 08 April 2019.

Objectives College is an exhilarating but stressful time often associated with mental distress. The StudiCare project offers Internet- and mobile-based interventions (IMI) for college student mental health promotion. Within this framework, we evaluated the IMI StudiCare Mindfulness, and examined potential moderators and mediators of effectiveness. Methods In this randomized controlled trial, 150 college students with low to moderate mindfulness were randomly assigned to StudiCare Mindfulness or a waitlist control group (WL). StudiCare Mindfulness comprises 5 weekly online modules based on Acceptance Commitment Therapy and stress management. Assessments took place before (t0) and 6 weeks after (t1) randomization. Primary outcome was mindfulness. Secondary outcomes were stress, depression, anxiety, quality of life, intervention satisfaction, and adherence. Sociodemographic variables, pre-intervention symptomatology, personality traits, and attitudes towards IMI were examined as potential moderators. Results Intention-to-treat analyses (N = 149) showed a large effect of StudiCare Mindfulness on mindfulness (d = 1.37; 95% CI: 1.01–1.73) compared to WL at t1 (β = 1.18; 95% CI: 0.96–1.40). Effects on secondary outcomes were significant in favor of the intervention group except for physical quality of life. Mindfulness was found to mediate intervention effectiveness on depression, anxiety, and stress. Moderation analysis was non-significant except for baseline openness to experience, with lower openness associated with larger intervention effects on mindfulness. Conclusions This trial suggests that StudiCare Mindfulness may enhance mindfulness and reduce mental health problems. Its potential applicability as low-threshold prevention and treatment option on a population level should be subject to future trials. Trial Registration German Clinical Studies Trial Register TRN: DRKS00012559., publishedVersion

IntroductionBehavioural activation is a highly effective treatment for depression. However, there is considerable heterogeneity of interventions grouped under the term ‘behavioural activation’. A main reason for the heterogeneity is the lack of a unified theory in the intervention development: few of the established intervention manuals give a theoretical rationale for their intervention techniques. For the first time, this study will examine the effectiveness of a theory-based behavioural activation intervention (InterAKTIV) based on the Health Action Process Approach. The intervention is implemented online to ensure broad dissemination and standardisation.Methods and analysisIn a two-arm randomised controlled trial, the effectiveness of a guided web-based behavioural activation intervention for people with depression will be evaluated. Participants are recruited via the print and online media of a large German healthcare insurance company. Individuals (age 18–65), who meet criteria for major depressive episode in a clinical interview and no exclusion criteria are eligible for inclusion. A target sample of 128 participants is randomly allocated to either the intervention group (immediate access to InterAKTIV) or treatment as usual (access after follow-up assessment). The primary outcome of depressive symptom severity (Quick Inventory of Depressive Symptomatology Clinician Rating) and secondary outcomes, including behavioural activation, physical activity and motivational and volitional outcomes are assessed at baseline, post treatment and 6-month follow-up. Data will be analysed on an intention-to-treat basis with additional per-protocol analyses.Ethics and disseminationThis trial is approved by the ethics committee of the Albert-Ludwigs-University of Freiburg (no.: 20-1045). All participants are required to submit their informed consent online before study inclusion. The results will be submitted for publication in a peer-reviewed journal and presented at conferences.Trial registration numberThis trial was registered in the German Clinical Trials Register (DRKS): DRKS00024349 (date of registration: 29 January 2021)., publishedVersion

Psychische Erkrankungen wie Depression und Angst beginnen haufig im Jugend- und jungen Erwachsenenalter. Heranwachsende mit einer chronischen rheumatischen Erkrankung haben hierfur ein besonderes Risiko. In Untersuchungen zur psychischen Gesundheit gaben in der Regel uber 10 % der Jugendlichen mit juveniler idiopathischer Arthritis (JIA) depressive Symptome an. Die fruhzeitige Erkennung von psychischen Belastungen ist notwendig, um Betroffenen rechtzeitig adaquate Unterstutzung anbieten zu konnen. Geschieht das nicht, werden Moglichkeiten, die Langzeitprognose und Lebensqualitat der Betroffenen zu verbessern, verpasst. Psychische Storungen werden in der klinischen Praxis oft nur am Rande berucksichtigt. Wie gros das Problem unter den bundesweit kinder- und jugendrheumatologisch betreuten Patienten mit JIA ist, wird in diesem Jahr im Rahmen des interdisziplinaren Forschungsverbundes COACH untersucht. Mental disorders such as depression and anxiety often begin in adolescence and young adulthood. Young people with a chronic rheumatic disease are particularly at risk. More than 10 % of young people with juvenile idiopathic arthritis reported depressive symptoms in most mental health studies. Early recognition of mental health problems is necessary in order to be able to support those affected in a timely and adequate manner. If this does not happen, opportunities to improve the long-term prognosis and quality of life of the young people affected are missed. Psychological stress is often only marginally considered in clinical practice. In order to improve this, the interdisciplinary research network COACH will, starting this year, investigate the extent of mental health problems in adolescents and young adults with JIA, who are receiving nationwide paediatric rheumatological care.

BACKGROUND: Depression occurs frequently in individuals with coronary artery disease (CAD) and is associated with a poor prognosis. OBJECTIVES: To determine the effects of psychological and pharmacological interventions for depression in CAD patients with comorbid depression. SEARCH METHODS: We searched the CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL databases up to August 2020. We also searched three clinical trials registers in September 2021. We examined reference lists of included randomised controlled trials (RCTs) and contacted primary authors. We applied no language restrictions. SELECTION CRITERIA: We included RCTs investigating psychological and pharmacological interventions for depression in adults with CAD and comorbid depression. Our primary outcomes included depression, mortality, and cardiac events. Secondary outcomes were healthcare costs and utilisation, health‐related quality of life, cardiovascular vital signs, biomarkers of platelet activation, electrocardiogram wave parameters, non‐cardiac adverse events, and pharmacological side effects. DATA COLLECTION AND ANALYSIS: Two review authors independently examined the identified papers for inclusion and extracted data from the included studies. We performed random‐effects model meta‐analyses to compute overall estimates of treatment outcomes. MAIN RESULTS: Thirty‐seven trials fulfilled our inclusion criteria. Psychological interventions may result in a reduction in end‐of‐treatment depression symptoms compared to controls (standardised mean difference (SMD) −0.55, 95% confidence interval (CI) −0.92 to −0.19, I(2) = 88%; low certainty evidence; 10 trials; n = 1226). No effect was evident on medium‐term depression symptoms one to six months after the end of treatment (SMD −0.20, 95% CI −0.42 to 0.01, I(2) = 69%; 7 trials; n = 2654). The evidence for long‐term depression symptoms and depression response was sparse for this comparison. There is low certainty evidence that psychological interventions may result in little to no difference in end‐of‐treatment depression remission (odds ratio (OR) 2.02, 95% CI 0.78 to 5.19, I(2) = 87%; low certainty evidence; 3 trials; n = 862). Based on one to two trials per outcome, no beneficial effects on mortality and cardiac events of psychological interventions versus control were consistently found. The evidence was very uncertain for end‐of‐treatment effects on all‐cause mortality, and data were not reported for end‐of‐treatment cardiovascular mortality and occurrence of myocardial infarction for this comparison. In the trials examining a head‐to‐head comparison of varying psychological interventions or clinical management, the evidence regarding the effect on end‐of‐treatment depression symptoms is very uncertain for: cognitive behavioural therapy compared to supportive stress management; behaviour therapy compared to person‐centred therapy; cognitive behavioural therapy and well‐being therapy compared to clinical management. There is low certainty evidence from one trial that cognitive behavioural therapy may result in little to no difference in end‐of‐treatment depression remission compared to supportive stress management (OR 1.81, 95% CI 0.73 to 4.50; low certainty evidence; n = 83). Based on one to two trials per outcome, no beneficial effects on depression remission, depression response, mortality rates, and cardiac events were consistently found in head‐to‐head comparisons between psychological interventions or clinical management. The review suggests that pharmacological intervention may have a large effect on end‐of‐treatment depression symptoms (SMD −0.83, 95% CI −1.33 to −0.32, I(2) = 90%; low certainty evidence; 8 trials; n = 750). Pharmacological interventions probably result in a moderate to large increase in depression remission (OR 2.06, 95% CI 1.47 to 2.89, I(2) = 0%; moderate certainty evidence; 4 trials; n = 646). We found an effect favouring pharmacological intervention versus placebo on depression response at the end of treatment, though strength of evidence was not rated (OR 2.73, 95% CI 1.65 to 4.54, I(2) = 62%; 5 trials; n = 891). Based on one to four trials per outcome, no beneficial effects regarding mortality and cardiac events were consistently found for pharmacological versus placebo trials, and the evidence was very uncertain for end‐of‐treatment effects on all‐cause mortality and myocardial infarction. In the trials examining a head‐to‐head comparison of varying pharmacological agents, the evidence was very uncertain for end‐of‐treatment effects on depression symptoms. The evidence regarding the effects of different pharmacological agents on depression symptoms at end of treatment is very uncertain for: simvastatin versus atorvastatin; paroxetine versus fluoxetine; and escitalopram versus Bu Xin Qi. No trials were eligible for the comparison of a psychological intervention with a pharmacological intervention. AUTHORS' CONCLUSIONS: In individuals with CAD and depression, there is low certainty evidence that psychological intervention may result in a reduction in depression symptoms at the end of treatment. There was also low certainty evidence that pharmacological interventions may result in a large reduction of depression symptoms at the end of treatment. Moderate certainty evidence suggests that pharmacological intervention probably results in a moderate to large increase in depression remission at the end of treatment. Evidence on maintenance effects and the durability of these short‐term findings is still missing. The evidence for our primary and secondary outcomes, apart from depression symptoms at end of treatment, is still sparse due to the low number of trials per outcome and the heterogeneity of examined populations and interventions. As psychological and pharmacological interventions can seemingly have a large to only a small or no effect on depression, there is a need for research focusing on extracting those approaches able to substantially improve depression in individuals with CAD and depression.

Introduction Farmers, forest workers and gardeners have a higher risk of developing depression compared to other occupational populations. As part of the German pilot project “With us in balance”, the potential of six guided internet- and mobile-based interventions (IMIs) to prevent depression among their insurants is examined. The IMI program is tailored to various risk factors of depression, individual symptoms, and needs. Although IMIs have been shown to be effective in reducing depressive symptoms, there is little qualitative research about the acceptance of digital preventive IMIs. The aim of this qualitative study is to gain insights into participants' experiences with the guided IMIs by focusing on determinants for acceptance and satisfaction. Methods Semi-structured interviews were conducted with 22/171 (13 %) intervention group (IG) participants of a randomized controlled trial. The interview guide was developed based on theoretical models of user acceptance (Unified Theory of Acceptance and Use of Technology) and patient satisfaction (evaluation model, discrepancy theory). The interviews were evaluated independently by two coders performing a deductive-inductive content analysis and attaining a substantial level of agreement (K = 0.73). Results The qualitative analysis revealed 71 determinants for acceptance and satisfaction across ten dimensions: performance expectancy, organisation, e-coach, usability, training content and structure, training usage, training outcome, financing, social influence, and behavioural intention. The most frequently identified drivers for the IMI use include “location independence”, “positive relationship to the e-coach” (each n = 19, 86 %), “personal e-coach guidance”, “expertise of the e-coach”, “target group specific adaptation” (each n = 18, 82 %), “flexibility”, “high willingness for renewed participation” (each n = 17, 77 %), “fast and easy availability”, “training of health enhancing attitudes and behaviours” and “content with figurative expressions” (each n = 16, 73 %). Discussion The qualitative findings predominantly suggest the acceptance of and satisfaction with the IMI program for the prevention of depression in famers and related lines of work. Many identified positive drivers are related to the e-coach guidance, which emphasizes its importance in the preventive setting from the perspective of the participants. Nevertheless, some negative aspects have been identified which help to understand potential weaknesses of the IMI program. Participants indicated different needs in terms of IMI content and usage, which points towards the potential benefit of individualisation. The possibility of being able to use IMIs anonymously, flexibly and independently of location might be highly relevant for this specific target group.

In the course of the corona virus (COVID-19) pandemic, many digital solutions for mobile devices (e.g., apps) were presented in order to provide additional resources supporting the control of the pandemic. Contact tracing apps (i.e., identify persons who may have been in contact with a COVID-19 infected) constitute one of the most popular as well as promising solutions. However, as a prerequisite for an effective application, such apps highly depend on being used by large numbers of the population. Consequently, it is important that these apps offer a high usability for everyone. We therefore conducted an exploratory study to learn more about the usability of the German COVID-19 contact tracing app Corona-Warn-App (CWA). More specifically, N = 15 participants assessed the CWA, relying on a combined eye tracking and retrospective think aloud approach. The results indicate, on the one hand, that the CWA leaves a promising impression for pandemic control, as essential functions are easily recognized. However, on the other hand, issues were revealed (e.g., privacy policy) that could be addressed in future updates more properly.

In the course of the recognition of mental health as an essential component of population health, the Robert Koch Institute has begun developing a Mental Health Surveillance (MHS) system for Germany. MHS aims to continuously report data for relevant mental health indicators, thus creating a basis for evidence-based planning and evaluation of public health measures. In order to develop a set of indicators for the adult population, potential indicators were identified through a systematic literature review and selected in a consensus process by international and national experts and stakeholders. The final set comprises 60 indicators which, together, represent a multidimensional public health framework for mental health across four fields of action. For the fifth field of action 'Mental health promotion and prevention' indicators still need to be developed. The methodology piloted proved to be practicable. Strengths and limitations will be discussed regarding the search and definition of indicators, the scope of the indicator set as well as the participatory decision-making process. Next steps in setting up the MHS will be the operationalisation of the single indicators and their extension to also cover children and adolescents. Given assured data availability, the MHS will contribute to broadening our knowledge on population mental health, supporting a targeted promotion of mental health and reducing the disease burden in persons with mental disorders.

Objective Evidence of long-term stability for positive mental health effects of internet-based interventions (IBIs) for depression prevention is still scarce. We evaluate long-term effectiveness of a depression prevention program in green professions (i.e. agriculture, horticulture, forestry). Methods This pragmatic RCT (n = 360) compares a tailored IBI program to enhanced treatment as usual (TAU+) in green professions with at least subthreshold depression (PHQ ≥ 5). Intervention group (IG) received one of six IBIs shown previously to efficaciously reduce depressive symptoms. We report 6- and 12-month follow-up measures for depression, mental health and intervention-related outcomes. Intention-to-treat and per-protocol regression analyses were conducted for each measurement point and complemented by latent growth modeling. Results After 6 months, depression severity (β = −0.30, 95%-CI: −0.52; −0.07), insomnia (β = −0.22, 95%-CI: −0.41; −0.02), pain-associated disability (β = −0.26, 95%-CI: −0.48; −0.04) and quality of life (β = 0.29, 95%-CI: 0.13; 0.45) in IG were superior to TAU+. Onset of possible depression was not reduced. After 12 months, no intervention effects were found. Longitudinal modeling confirmed group effects attenuating over 12 months for most outcomes. After 12 months, 55.56% of IG had completed at least 80% of their IBI. Conclusions Stability of intervention effects along with intervention adherence was restricted. Measures enhancing long-term effectiveness of IBIs for depression health promotion are indicated in green professions. Trial registration German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018., Highlights • This tailored IBI program reduced depression severity only medium-term. • Longitudinal modeling revealed no long-term effect for depression reduction. • Longitudinal modeling showed most health-promoting effects attenuated over time. • Adherence was restricted as only every second participant completed the training. • Adherence-enhancing measures are highly indicated in this occupational target group.

IntroductionIt is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I.Methods and analysisIn this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model.Ethics and disseminationThe study protocol was approved by the Ethics Committee of the Medical Centre—University of Freiburg. The results of the study will be published irrespective of the outcome.Trial registration numberDRKS00021503., publishedVersion

While studies mainly provide positive evidence for the efficacy of internet-delivered cognitive-behavioral therapy (ICBT) for various persistent somatic symptoms, it remains largely unclear for whom these interventions work or not. This exploratory analysis aimed to identify moderators for the outcome between ICBT for somatic symptom distres and a waitlist control group (WL) in a vulnerable target group of emerging adults.Based on data from a randomized controlled trial on 156 university students with varying degrees of somatic symptom distress who were allocated to either an eight-week, therapist guided ICBT (iSOMA) or to the WL, we examined pretreatment demographic characteristics, health-related variables (e.g., somatic symptom duration), mental distress (e.g., depression, anxiety) and cognitive-emotional factors (emotional reactivity, somatosensory amplification) as candidate moderators of the outcome, somatic symptom distress (assessed by the Patient Health Questionnaire, PHQ-15) from pre- to posttreatment.Somatosensory amplification (assessed by the Somatosensory Amplification Scale, SSAS) moderated the outcome in favor of iSOMA (B = -0.17, SE = 0.08, p = 0.031), i.e., higher pretreatment somatosensory amplification was associated with better outcome in the active compared to the control intervention. No significant moderation effects were found among demographic characteristics, health-related variables, or mental distress.Our findings suggest that an internet-delivered CBT for somatic symptom distress should be preferred over no active treatment particularly in individuals with moderate to high levels of somatosensory amplification, which as a next step should be tested against further treatments and in clinical populations.German Clinical Trials Register (DRKS00014375).

Musculoskeletal symptoms are increased in farmers, whereas the prevalence of chronified pain is unknown. Online interventions based on acceptance and commitment therapy (ACT) have shown encouraging results in the general population, representing a promising approach for reducing pain interference in green professions (i.e., farmers, foresters, gardeners). We conducted a pragmatic RCT comparing a guided ACT-based online intervention to enhanced treatment-as-usual in entrepreneurs, contributing spouses, family members and pensioners in green professions with chronic pain (CPG: ≥grade II, ≥6 months). Recruitment was terminated prematurely after 2.5 years at N = 89 (of planned N = 286). Assessments were conducted at 9 weeks (T1), 6 months (T2) and 12 months (T3) post-randomization. The primary outcome was pain interference (T1). The secondary outcomes encompassed pain-, health- and intervention-related variables. No treatment effect for reduction of pain interference was found at T1 (β = −0.16, 95%CI: −0.64–0.32, p = 0.256). Improvements in cognitive fusion, pain acceptance, anxiety, perceived stress and quality of life were found only at T3. Intervention satisfaction as well as therapeutic and technological alliances were moderate, and uptake and adherence were low. Results are restricted by low statistical power due to recruitment issues, high study attrition and low intervention adherence, standing in contrast to previous studies. Further research is warranted regarding the use of ACT-based online interventions for chronic pain in this occupational group. Trial registration: German Clinical Trial Registration: DRKS00014619. Registered: 16 April 2018.

IntroductionLiving with diabetes can be burdensome and lead to serious emotional distress and impaired mental health. Acceptance and commitment therapy (ACT) can support people facing the challenges of living with diabetes. This trial aims to evaluate the effectiveness and cost-effectiveness of the internet-based and mobile-based intervention (IMI) ‘ACTonDiabetes’ in reducing diabetes distress against enhanced treatment as usual (TAU+) following specialised diabetes care.Methods and analysisA two-armed pragmatic randomised controlled trial will be conducted to evaluate the guided IMI ACTonDiabetes against TAU+. A total of 210 adults with type 1 or type 2 diabetes and elevated diabetes distress (Problem Areas in Diabetes ≥40) will be recruited at a specialised diabetes centre. The intervention begins 2–4 weeks after hospital discharge and takes about 7–10 weeks to complete. Assessments are performed at baseline and 5 and 10 weeks as well as 6 and 12 months after randomisation. The primary outcome is diabetes distress at a 10-week follow-up (T2). Secondary outcomes are depression (Patient Health Questionnaire-8), psychological well-being (WHO-5), quality of life (Assessment of Quality of Life-8 Dimension), Diabetes-related Self-Management Questionnaire, diabetes acceptance (Acceptance and Action Diabetes Questionnaire) and negative treatment effects (Inventory for the Assessment of Negative Effects of Psychotherapy). All statistical analyses will be performed based on the intention-to-treat principle with additional per-protocol analyses. Changes in outcomes will be evaluated using the general linear model. A health-economic evaluation will be conducted from a societal perspective. Reasons for drop-out will be systematically investigated.Ethics and disseminationThis clinical trial has been approved by the State Medical Chamber of Baden-Württemberg (file no. B-F-2019-010). Trial results will be submitted for publication in a peer-reviewed journal and presented at conferences.Trial registration numberDRKS00016738.

ObjectivesThis two-group randomised controlled trial evaluates the feasibility of an Acceptance and Commitment Therapy (ACT)-based internet intervention for diabetes distress in people with diabetes type 1 or type 2. Participants were assigned to a guided self-help intervention (EG) or waitlist control group (CG).SettingRecruitment took place following an open recruitment strategy including different diabetes centres, self-help groups and social media platforms.ParticipantsEligibility criteria comprised being 18 years of age or older, self-reported diagnosis of type 1 or type 2 diabetes, internet access, sufficient German language skills and written informed consent.InterventionACTonDiabetes is an internet-based and mobile-based intervention and comprises an introduction and seven modules (one module per week, processing time about 45–60 min). Intervention contents are based on ACT.Primary and secondary outcome measuresParticipants were assessed before and 8 weeks after randomisation. Primary outcome was feasibility (trial recruitment, acceptability). Potential group differences in diabetes distress and other outcomes at follow-up were analysed using linear regression models with baseline values as predictors. All analyses were based on an intention-to-treat principle, potential negative effects were analysed on per-protocol basis.ResultsFrom October 2017 to April 2018, N=42 people with diabetes consented and were randomised (EG n=21, CG n=21). Forty-three per cent of the EG completed all treatment modules within 8 weeks. Across modules, formative user feedback revealed that contents could be optimised regarding comprehensibility (34%), individualisation (20%) and text amount (21%). Overall, 57% of participants dropped out prior to full treatment completion. There were reductions of diabetes distress in the EG (d=0.65, p=0.042).ConclusionsModifications of the intervention content according to the user feedback will be performed to further improve acceptability. Mechanisms to foster intervention adherence should be considered for lowering the attrition rate. ACTonDiabetes is feasible for the implementation in a confirmatory trial.Trial registration numberWHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS) (DRKS00013193).

Research in mental health services in Germany is of increasing relevance. To this end, the recently founded "Mental Health Working Group" as part of the German Network of Health Services Research (DNVF) has written a discussion paper presenting key specifics, challenges, and goals of health service research in the field of mental health. Some research-relevant specifics in the area of mental health care, pragmatic challenges of research organization, ethical problems, and particular research topics in this field are presented and discussed critically.Versorgungsforschung im Feld der seelischen Gesundheit ist von zunehmender Bedeutung. Angesichts dieser Entwicklung hat die im Oktober 2017 gegründete DNVF Fachgruppe „Seelische Gesundheit“ ein Diskussionspapier verfasst, welches zentrale Besonderheiten, Herausforderungen und Ziele der Versorgungsforschung im Bereich der seelischen Gesundheit zusammenfasst. Im Einzelnen werden forschungsrelevante Besonderheiten des Versorgungsfeldes, pragmatische Probleme bei der Forschungsorganisation, ethische Herausforderungen und für dieses Feld besondere Themenstellungen vorgestellt und diskutiert.

BackgroundEvidence on technology-based psychological interventions (TBIs) for the acute treatment of depression is rapidly growing. Despite extensive research in this field, there is a lack of research determining effectiveness and acceptance of TBIs considering different application formats in people with a formally diagnosed depressive disorder. ObjectiveThe goal of the review was to investigate the effectiveness and acceptance of TBIs in people with diagnosed depression with particular focus on application formats (stand-alone interventions, blended treatments, collaborative and/or stepped care interventions). MethodsStudies investigating adults with diagnosed unipolar depressive disorders receiving any kind of psychotherapeutic treatment delivered (at least partly) by a technical medium and conducted as randomized controlled trials (RCTs) were eligible for inclusion. We searched CENTRAL (Cochrane Central Register of Controlled Trials; August 2020), MEDLINE, PsycINFO, PSYNDEX, CINAHL (January 2018), clinical trial registers, and sources of grey literature (January 2019). Two independent authors decided about study inclusion and extracted data. We performed random effects meta-analyses to synthesize the data. ResultsDatabase searches resulted in 15,546 records of which 78 completed studies were included. TBIs delivered as stand-alone interventions showed positive effects on posttreatment depression severity when compared to treatment as usual (SMD –0.44, 95% CI –0.73 to –0.15, k=10; I²=86%), attention placebo (SMD –0.51, 95% CI –0.73 to –0.30; k=12; I²=66%), and waitlist controls (SMD –1.01, 95% CI –1.23 to –0.79; k=19; I²=73%). Superior long-term effects on depression severity were shown when TBIs were compared to treatment as usual (SMD –0.24, 95% CI –0.41 to –0.07; k=6; I²=48%) attention placebo (SMD –0.23, 95% CI –0.40 to –0.07; k=7; I²=21%) and waitlist controls (SMD –0.74, 95% CI –1.31 to –0.18; k=3; I²=79%). TBIs delivered as blended treatments (providing a TBI as an add-on to face-to-face treatment) yielded beneficial effects on posttreatment depression severity (SMD –0.27, 95% CI –0.48 to –0.05; k=8; I²=53%) compared to face-to-face treatments only. Additionally, TBIs delivered within collaborative care trials were more effective in reducing posttreatment (SMD –0.20, 95% CI –0.36 to –0.04; k=2; I²=0%) and long-term (SMD –0.23, 95% CI –0.39 to –0.07; k=2; I²=0%) depression severity than usual care. Dropout rates did not differ between the intervention and control groups in any comparison (all P≥.09). ConclusionsWe found that TBIs are effective not only when delivered as stand-alone interventions but also when they are delivered as blended treatments or in collaborative care trials for people with diagnosed depression. Our results may be useful to inform routine care, since we focused specifically on different application formats, formally diagnosed patients, and the long-term effectiveness of TBIs. Trial RegistrationPROSPERO International Prospective Register of Systematic Reviews CRD42016050413; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42016050413 International Registered Report Identifier (IRRID)RR2-10.1136/bmjopen-2018-028042

Loneliness and lack of social well-being are associated with adverse health outcomes and have increased during the COVID-19 pandemic. Smartphone communication data have been suggested to help monitor loneliness, but this requires further evidence. We investigated the informative value of smartphone communication app data for predicting subjective loneliness and social well-being in a sample of 364 participants ranging from 18 to 78 years of age (52.2% female; mean age = 42.54, SD = 13.22) derived from the CORONA HEALTH APP study from July to December 2020 in Germany. The participants experienced relatively high levels of loneliness and low social well-being during the time period characterized by the COVID-19 pandemic. Apart from positive associations with phone call use times, smartphone communication app use was associated with social well-being and loneliness only when considering the age of participants. Younger participants with higher use times tended to report less social well-being and higher loneliness, while the opposite association was found for older adults. Thus, the informative value of smartphone communication use time was rather small and became evident only in consideration of age. The results highlight the need for further investigations and the need to address several limitations in order to draw conclusions at the population level., publishedVersion

Onlinetherapie ist ein verstarkt genutzter Ansatz in der Pravention, Behandlung und Nachsorge verschiedener psychischer Storungsbilder, mit vielversprechenden Moglichkeiten, die Versorgung zu erganzen und bestehende Lucken zu verkleinern. Die Wirksamkeit konnte in zahlreichen Studien belegt werden. Im Fokus der Forschung stehen derzeit Aspekte einer geeigneten Implementierung in die Routineversorgung sowie die Weiterentwicklung vor dem Hintergrund neuer digitaler Moglichkeiten.