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Introduction: Although evidence-based treatments for posttraumatic stress disorder (PTSD) in adolescents and young adults exist, affected youth do not have sufficient access to these treatments due to structural and attitudinal barriers. Internet- and mobile-based interventions (IMIs) can help fill this healthcare gap, but such programmes have not yet been sufficiently evaluated in youth with PTSD. Aim: This study aims to investigate the feasibility of an IMI for youth with PTSD in a one-arm, non-randomised, prospective proof-of-concept feasibility study. Methods: We aim to recruit 32 youth between 15 and 21 years old with clinically relevant posttraumatic stress symptoms (CATS ≥ 21), who will receive access to the IMI. The IMI consists of nine sessions involving psychoeducation, emotion regulation and coping skills, written-based imaginal exposure, cognitive restructuring and relapse prevention. Participants will be guided by an eCoach, who provides weekly semi-standardised written feedback on completed sessions and adherence reminders. We will use a formal feasibility framework to assess different dimensions of feasibility: (1) recruitment capability and resulting sample characteristics, (2) data collection procedures and outcome measures, (3) acceptability of the IMI and study procedures, (4) resources and ability to manage and implement the study and IMI and (5) participants' responses to the IMI in terms of symptom severity and satisfaction. Additionally, potential negative effects related to the intervention will be assessed. Assessments take place pre-, mid- and post-intervention and at follow-up, including semi-structured clinical telephone interviews for PTSD diagnostics at pre- and post-intervention assessment. Qualitative interviews will be conducted to investigate the youth perspectives on the IMI. Discussion: This study aims to determine the feasibility of a guided IMI for youth with PTSD to adapt the IMI as closely as possible to youth needs and to inform the design, procedure and safety management of a large-scale efficacy RCT. Trial registration: German Clinical Trials Register identifier: DRKS00023341., Highlights: Evidence-based care for adolescents after trauma is not widely available.• This study evaluates the feasibility of a guided trauma-focused Internet intervention as a time- and location-independent low-threshold treatment option for adolescents and young adults with posttraumatic stress disorder., Competing Interests: Christina Schulte (CS), Cedric Sachser (CeS), Anna-Carlotta Zarski (AZ) and Rita Rosner have nothing to disclose. David Daniel Ebert (DE) reports other from Get.On Institute, personal fees from Sanofi, personal fees from Novartis, personal fees from Minddistrict, personal fees from Lantern, personal fees from Schoen Kliniken, personal fees from Ideamed, grants from EU H2020, grants from BMBF, outside the submitted work; and Dr. Ebert has served as a consultant to/on the scientific advisory boards of Sanofi, Novartis, Minddistrict, Lantern, Schoen Kliniken, Ideamed and German health insurance companies (BARMER, Techniker Krankenkasse) and a number of federal chambers for psychotherapy. He is also a stakeholder in the institute for health training online (formerly GET.ON, now HelloBetter), which aims to implement scientific findings related to digital health interventions into routine care. HelloBetter distributes the Internet platform for the digital intervention under study., (© 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

Background: Adherence reflects the extent to which individuals experience or engage with the content of online interventions and poses a major challenge. Neglecting to examine and report adherence and its relation to outcomes can compromise the interpretation of research findings., Objective: The aim of this systematic review is to analyze how adherence is accounted for in publications and to propose standards for measuring and reporting adherence to online interventions., Methods: We performed a systematic review of randomized controlled trials on online interventions for the prevention and treatment of common mental disorders (depression, anxiety disorders, substance related disorders, and eating disorders) published between January 2006 and May 2018 and indexed in Medline and Web of Science. We included primary publications on manualized online treatments (more than 1 session and successive access to content) and examined how adherence was reported in these publications., Results: We identified 216 publications that met our inclusion criteria. Adherence was addressed in 85% of full-text manuscripts, but only in 31% of abstracts. A median of three usage metrics were reported; the most frequently reported usage metric (61%) was intervention completion. Manuscripts published in specialized electronic health journals more frequently included information on the relation of adherence and outcomes., Conclusions: We found substantial variety in the reporting of adherence and the usage metrics used to operationalize adherence. This limits the comparability of results and impedes the integration of findings from different studies. Based on our findings, we propose reporting standards for future publications on online interventions., (©Ina Beintner, Bianka Vollert, Anna-Carlotta Zarski, Felix Bolinski, Peter Musiat, Dennis Görlich, David Daniel Ebert, Corinna Jacobi. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 15.08.2019.)

Background: Social anxiety disorder (SAD) is highly prevalent among university students, but the majority of affected students remain untreated. Internet- and mobile-based self-help interventions (IMIs) may be a promising strategy to address this unmet need. This study aims to investigate the efficacy and cost-effectiveness of an unguided internet-based treatment for SAD among university students. The intervention is optimized for the treatment of university students and includes one module targeting fear of positive evaluations that is a neglected aspect of SAD treatment., Methods: The study is a two arm randomized controlled trial in which 200 university students with a primary diagnosis of SAD will be assigned randomly to either a wait-list control group (WLC) or the intervention group (IG). The intervention consists of 9 sessions of an internet-based cognitive-behavioral treatment, which also includes a module on fear of positive evaluation (FPE). Guidance is delivered only on the basis of standardized automatic messages, consisting of positive reinforcements for session completion, reminders, and motivational messages in response to non-adherence. All participants will additionally have full access to treatment as usual. Diagnostic status will be assessed through Structured Clinical Interviews for DSM Disorders (SCID). Assessments will be completed at baseline, 10 weeks and 6-month follow-up. The primary outcome will be SAD symptoms at post-treatment, assessed via the Social Phobia Scale (SPS) and the Social Interaction Anxiety Scale (SIAS). Secondary outcomes will include diagnostic status, depression, quality of life and fear of positive evaluation. Cost-effectiveness and cost-utility analyses will be evaluated from a societal and health provider perspective., Discussion: Results of this study will contribute to growing evidence for the efficacy and cost-effectiveness of unguided IMIs for the treatment of SAD in university students. Consequently, this trial may provide valuable information for policy makers and clinicians regarding the allocation of limited treatment resources to such interventions., Trial Registration: DRKS00011424 (German Clinical Trials Register (DRKS)) Registered 14/12/2016.

Numerous self-management interventions have proven to be efficacious in the treatment of a number of mental disorders in randomized trials. However, these interventions have not yet reached clinical routine everywhere. Among other things, this is due to the fact that, in addition to the evidence-based interventions, other interventions are offered that have never been scientifically investigated, and in some cases, do not even rely on evidence-based methods of psychotherapy. The present quality criteria, developed by the two professional associations DGPs and DGPPN, are intended to help patients, practitioners and decision-makers in the health care sector to identify safe and efficacious interventions. The core quality criteria cover the following aspects: safety of patients and their data; ensuring therapeutic quality by using evidence-based psychotherapeutic methods and developing the intervention in liaison with licensed psychotherapists or medical specialists; the presence of proof of efficacy from at least one randomized trial; and transparency regarding key information, e. g., the cost of the intervention. We hope that these criteria can contribute to the inclusion of self-management interventions in the range of services covered by statutory health insurance companies., Competing Interests: MB erhält Forschungsgelder von DFG, BMBF, AOK Baden Württemberg. DDE erhält themenbezogene Forschungsgelder von EU, BMBF, DFG, BARMER, DRV, Unfallkasse, dem Innovationsfond sowie Beraterhonorare hinsichtlich Internet Interventionen von TK, Sanofi, Novartis, Minddistrict, Lantern, Schön Kliniken, Agaplesion, zudem ist er Teilhaber des GET.ON Institutes GmbH, dessen Ziel es ist evidenz-basierte Internet-basierte Interventionen in der Regelversorgung verfügbar zu machen. CJ erhielt Bezahlung / Honorare für Bücher (Beltz; Hogrefe) über Verhaltenstherapie bei Essstörungen und erhält Forschungsgelder von der European Commission. JPK erhält Finanzierung für klinische Studien (Bundesministerium für Gesundheit; Firma Servier, welche die Selbstmanagement Intervention deprexis vertreibt), Bezahlung für Vorträge zu Internetinterventionen (Servier) und Bezahlung für Workshops und Bücher (Beltz, Elsevier, Hogrefe) über Psychotherapie Chronischer Depression und Psychiatrische Notfälle. Er kooperiert mit der Firma GAIA bei der Durchführung von klinischen Studien zu Selbstmanagement Interventionen (deprexis und priovi). CK erhält Forschungsgelder von DFG, BMBF, BMVG, BMZ sowie der TK. ML führt themenbezogene wissenschaftliche Forschungsprojekte durch, die von der DFG, vom BMBF, und der AOK Bund finanziert werden (institutsgebundene Grants). SRH führt themenbezogene wissenschaftliche Forschungsprojekte durch, die von der DFG, vom BMBF, dem Innovationsfond und der AOK Bund finanziert werden (institutsgebundene Grants). US hielt bezahlte Vorträge für die Firma Servier und ist Mitglied des Wissenschaftsboards der Firma Otsuka. Er erhält Finanzierung für klinische Studien vom Bundesministerium für Gesundheit und er ist wissenschaftlicher Leiter der Internet-Psychotherapie „net-step“ am SAJK Neuss., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: This study's aims were to compare the efficacy and negative effects of guided Internet-based cognitive behavior therapy (iCBT) and online psychoeducation (OPE) in people with major depression., Methods: A total of 131 individuals were randomized. Assessments took place at baseline (T1), six weeks (T2), and three months (T3). The primary endpoint was change in observer-based depression severity from T1 to T2. Potential negative effects were analyzed in terms of suicidal ideations, symptom deterioration, attitudes toward seeking further help, and other adverse events., Results: iCBT (n = 65) and OPE (n = 66) both reduced depressive symptoms from T1 to T2, with large changes observed for iCBT and medium for OPE (iCBT: Cohen's d = 1.09; OPE: d = 0.60). Differences between groups were significant at the primary endpoint (d = 0.36, p = 0.028). OPE continued to have a positive effect from post-treatment to follow-up, while the effect of iCBT remained stable, with differences between groups not being significant anymore at follow-up. Participants who had undergone prior psychotherapy benefited from both treatments; but for those without prior psychotherapy, iCBT was superior also at follow-up. In the iCBT group 26.2% of the participants reported at least one side-effect., Limitations: The history of psychotherapy was imbalanced between the groups. Some negative effects were assessed in the iCBT group only., Conclusions: Both iCBT and OPE were effective in reducing depressive symptoms, but with iCBT having a more rapid effect. iCBT was specifically superior in those with no prior history of psychotherapy. Negative effects occurred frequently and should be considered when implementing iCBT., Trial Registration: German clinical trials register: DRKS00005025., (Copyright © 2018. Published by Elsevier B.V.)

Introduction: Persistent and distressing somatic symptoms are common in younger age cohorts such as university students. However, the majority does not receive adequate psychosocial care. Internet-based and mobile-based interventions may represent low threshold and effective extensions to reduce somatic and associated mental symptom severity. The planned study aims to investigate the feasibility and efficacy of an internet-based intervention in reducing somatic and psychological symptoms in an international population of university students with somatic symptom burden., Methods and Analysis: This parallel two-armed randomised controlled trial evaluates an 8-week guided intervention, including web-based consecutive modules based on cognitive behavioural therapy (CBT) principles against a waitlist control group. Guidance will be provided by trained psychologists with weekly written supportive feedback. As part of the 'Studicare' project, the present study aims to recruit n=154 university students indicating somatic symptom burden at baseline in German-speaking universities. Self-report assessments will take place at baseline and after intervention completion (8, 16 weeks after randomisation). The primary outcome will be the severity of somatic symptoms and associated mental distress. Secondary outcomes include depression, (health) anxiety, disability, intervention satisfaction and adherence., Ethics and Dissemination: Ethics approval has been granted. Results from this study will be published in peer-reviewed journals and presented at international conferences., Trial Registration Number: DRKS00014375; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Internet- and mobile-based interventions are effective for the treatment of chronic pain. However, little is known about patients' willingness to engage with these types of interventions and how the uptake of such interventions can be improved., Objective: The aim of this study was to identify people's acceptance, uptake, and adherence (primary outcomes) with regard to an internet- and mobile-based intervention for chronic pain and the influence of an information video as an acceptance-facilitating intervention (AFI)., Methods: In this randomized controlled trial with a parallel design, we invited 489 individuals with chronic pain to participate in a Web-based survey assessing the acceptance of internet- and mobile-based interventions with the offer to receive an unguided internet- and mobile-based intervention for chronic pain after completion. Two versions of the Web-based survey (with and without AFI) were randomly sent to two groups: one with AFI (n=245) and one without AFI (n=244). Participants who completed the Web-based survey with or without AFI entered the intervention group or the control group, respectively. In the survey, the individuals' acceptance of pain interventions, measured with a 4-item scale (sum score ranging from 4 to 20), predictors of acceptance, sociodemographic and pain-related variables, and physical and emotional functioning were assessed. Uptake rates (log in to the intervention) and adherence (number of completed modules) to the intervention was assessed 4 months after intervention access. To examine which factors influence acceptance, uptake rate, and adherence in the internet- and mobile-based interventions, we conducted additional exploratory subgroup analyses., Results: In total, 57 (intervention group) and 58 (control group) participants in each group completed the survey and were included in the analyses. The groups did not differ with regard to acceptance, uptake rate, or adherence (P=.64, P=.56, P=.75, respectively). Most participants reported moderate (68/115, 59.1%) to high (36/115, 31.3%) acceptance, with 9.6% (11/115) showing low acceptance (intervention group: mean 13.91, SD 3.47; control group: mean 13.61, SD 3.50). Further, 67% (38/57, intervention group) and 62% (36/58, control group) had logged into the intervention. In both groups, an average of 1.04 (SD 1.51) and 1.14 (SD 1.90) modules were completed, respectively., Conclusions: The informational video was not effective with regard to acceptance, uptake rate, or adherence. Despite the high acceptance, the uptake rate was only moderate and adherence was remarkably low. This study shows that acceptance can be much higher in a sample participating in an internet- and mobile-based intervention efficacy trial than in the target population in routine health care settings. Thus, future research should focus not only on acceptance and uptake facilitating interventions but also on ways to influence adherence. Further research should be conducted within routine health care settings with more representative samples of the target population., Trial Registration: German Clinical Trial Registration DRKS00006183; http://www.drks.de/drks_web/navigate.do ?navigationId=trial.HTML&TRIAL_ID=DRKS00006183 (Archived by WebCite at http://www.webcitation.org/70ebHDhne)., (©Jiaxi Lin, Bianca Faust, David Daniel Ebert, Lena Krämer, Harald Baumeister. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 21.08.2018.)

Little is known about clinically relevant changes in guided Internet-based interventions for depression. Moreover, methodological and power limitations preclude the identification of patients' groups that may benefit more from these interventions. This study aimed to investigate response rates, remission rates, and their moderators in randomized controlled trials (RCTs) comparing the effect of guided Internet-based interventions for adult depression to control groups using an individual patient data meta-analysis approach. Literature searches in PubMed, Embase, PsycINFO and Cochrane Library resulted in 13,384 abstracts from database inception to January 1, 2016. Twenty-four RCTs (4889 participants) comparing a guided Internet-based intervention with a control group contributed data to the analysis. Missing data were multiply imputed. To examine treatment outcome on response and remission, mixed-effects models with participants nested within studies were used. Response and remission rates were calculated using the Reliable Change Index. The intervention group obtained significantly higher response rates (OR = 2.49, 95% CI 2.17-2.85) and remission rates compared to controls (OR = 2.41, 95% CI 2.07-2.79). The moderator analysis indicated that older participants (OR = 1.01) and native-born participants (1.66) were more likely to respond to treatment compared to younger participants and ethnic minorities respectively. Age (OR = 1.01) and ethnicity (1.73) also moderated the effects of treatment on remission.Moreover, adults with more severe depressive symptoms at baseline were more likely to remit after receiving internet-based treatment (OR = 1.19). Guided Internet-based interventions lead to substantial positive treatment effects on treatment response and remission at post-treatment. Thus, such interventions may complement existing services for depression and potentially reduce the gap between the need and provision of evidence-based treatments., (Copyright © 2018. Published by Elsevier Ltd.)

Background: Mental health problems are highly prevalent among college students. Most students with poor mental health, however, do not receive professional help. Internet-based self-help formats may increase the utilization of treatment., Objective: The aim of this randomized controlled trial was to evaluate the efficacy of an internet-based, app-supported stress management intervention for college students., Methods: College students (n=150) with elevated levels of stress (Perceived Stress Scale 4-item version, PSS-4 ≥8) were randomly assigned to either an internet- and mobile-based stress intervention group with feedback on demand or a waitlist control group. Self-report data were assessed at baseline, posttreatment (7 weeks), and 3-month follow-up. The primary outcome was perceived stress posttreatment (PSS-4). Secondary outcomes included mental health outcomes, modifiable risk and protective factors, and college-related outcomes. Subgroup analyses were conducted in students with clinically relevant symptoms of depression (Center for Epidemiological Studies' Depression Scale >17)., Results: A total of 106 participants (76.8%) indicated that they were first-time help-seekers, and 77.3% (intervention group: 58/75; waitlist control group: 58/75) showed clinically relevant depressive symptoms at baseline. Findings indicated significant effects of the intervention compared with the waitlist control group for stress (d=0.69; 95% CI 0.36-1.02), anxiety (d=0.76; 95% CI 0.43-1.09), depression (d=0.63; 95% CI 0.30-0.96), college-related productivity (d=0.33; 95% CI 0.01-0.65), academic work impairment (d=0.34; 95% CI 0.01-0.66), and other outcomes after 7 weeks (posttreatment). Response rates for stress symptoms were significantly higher for the intervention group (69%, 52/75) compared with the waitlist control group (35%, 26/75, P<.001; number needed to treat=2.89, 95% CI 2.01-5.08) at posttest (7 weeks). Effects were sustained at 3-month follow-up, and similar findings emerged in students with symptoms of depression., Conclusions: Internet- and mobile-based interventions could be an effective and cost-effective approach to reduce consequences of college-related stress and might potentially attract students with clinically relevant depression who would not otherwise seek help., Trial Registration: German Clinical Trial Register DRKS00010212; http://www.drks.de/drks&#95;web/navigate.do? navigationId=trial.HTML&TRIAL&#95;ID=DRKS00010212 (Archived by WebCite at http://www.webcitation.org/6w55Ewhjd)., (©Mathias Harrer, Sophia Helen Adam, Rebecca Jessica Fleischmann, Harald Baumeister, Randy Auerbach, Ronny Bruffaerts, Pim Cuijpers, Ronald C Kessler, Matthias Berking, Dirk Lehr, David Daniel Ebert. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 23.04.2018.)

Aims: To test the efficacy of a web-based alcohol intervention with and without guidance., Design: Three parallel groups with primary end-point after 6 weeks., Setting: Open recruitment in the German working population., Participants: Adults (178 males/256 females, mean age 47 years) consuming at least 21/14 weekly standard units of alcohol (SUA) and scoring ≥ 8/6 on the Alcohol Use Disorders Identification Test., Intervention: Five web-based modules including personalized normative feedback, motivational interviewing, goal setting, problem-solving and emotion regulation during 5 weeks. One intervention group received an unguided self-help version (n=146) and the second received additional adherence-focused guidance by eCoaches (n=144). Controls were on a waiting list with full access to usual care (n=144)., Measurements: Primary outcome was weekly consumed SUA after 6 weeks. SUA after 6 months was examined as secondary outcome, next to numbers of participants drinking within the low-risk range, and general and work-specific mental health measures., Findings: All groups showed reductions of mean weekly SUA after 6 weeks (unguided: -8.0; guided: -8.5; control: -3.2). There was no significant difference between the unguided and guided intervention (P=0.324). Participants in the combined intervention group reported significantly fewer SUA than controls [B=-4.85, 95% confidence interval (CI)=-7.02 to -2.68, P < 0.001]. The intervention groups also showed significant reductions in SUA consumption after 6 months (B=-5.72, 95% CI=-7.71 to -3.73, P < 0.001) and improvements regarding general and work-related mental health outcomes after 6 weeks and 6 months., Conclusions: A web-based alcohol intervention, administered with or without personal guidance, significantly reduced mean weekly alcohol consumption and improved mental health and work-related outcomes in the German working population., (© 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)

Objective This study aimed to estimate and evaluate the cost-effectiveness and cost-benefit of a guided internet- and mobile-supported occupational stress-management intervention (iSMI) for employees from the employer's perspective alongside a randomized controlled trial. Methods A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale, PSS-10 ≥22) was randomly assigned either to the iSMI or a waitlist control (WLC) group with unrestricted access to treatment as usual. The iSMI consisted of seven sessions of problem-solving and emotion-regulation techniques and one booster session. Self-report data on symptoms of perceived stress and economic data were assessed at baseline, and at six months following randomization. A cost-benefit analysis (CBA) and a cost-effectiveness analysis (CEA) with symptom-free status as the main outcome from the employer's perspective was carried out. Statistical uncertainty was estimated using bootstrapping (N=5000). Results The CBA yielded a net-benefit of EUR181 [95% confidence interval (CI) -6043-1042] per participant within the first six months following randomization. CEA showed that at a willingness-to-pay ceiling of EUR0, EUR1000, EUR2000 for one additional symptom free employee yielded a 67%, 90%, and 98% probability, respectively, of the intervention being cost-effective compared to the WLC. Conclusion The iSMI was cost-effective when compared to WLC and even lead to cost savings within the first six months after randomization. Offering stress-management interventions can present good value for money in occupational healthcare.

Background: Many individuals engaging in Internet-based interventions fail to complete these treatments as intended. The processes responsible for treatment adherence in Internet-based interventions are still poorly understood., Objective: The aim of this study was to investigate to what extent adherence in an Internet-based intervention can be predicted by motivational and volitional factors outlined in the health action process approach (HAPA)., Methods: This study investigated motivational and volitional factors included in HAPA in a randomized controlled trial to predict treatment adherence of N=101 individuals with subclinical depression in the intervention group of a depression prevention intervention (GET.ON Mood Enhancer). Adherence was operationalized as the number of completed treatment modules. Using longitudinal structural equation modeling, HAPA variables (motivational, maintenance, and recovery self-efficacy, outcome expectancies, intention, and planning) were assessed at baseline and their associations with adherence 7 weeks later., Results: Planning predicted adherence. Better planning was, in turn, associated with higher levels of maintenance self-efficacy, and the latter significantly affected treatment adherence via planning. The other hypothesized direct associations were not significant. In total, the HAPA variables accounted for 14% of variance in treatment adherence., Conclusions: Planning emerged as the strongest predictor of treatment adherence in highly motivated participants in an Internet-based intervention out of all HAPA variables investigated. Findings are in line with the hypothesis that planning facilitates the translation of good intentions into actions. The findings imply that systematically fostering planning skills and maintenance self-efficacy prior to or during Internet-based interventions would help participants to successfully complete these treatments., Trial Registration: German Clinical Trials Register DRKS00005973; https://www.drks.de/drks&#95;web/navigate.do? navigationId=trial.HTML&TRIAL&#95;ID=DRKS00005973 (Archived by WebCite at http://www.webcitation.org/6uxCy64sy)., (©Anna-Carlotta Zarski, Matthias Berking, Dorota Reis, Dirk Lehr, Claudia Buntrock, Ralf Schwarzer, David Daniel Ebert. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 11.01.2018.)

Evidence for the impact of psychological Interventions for subthreshold depression (sD) is conflicting. Moreover, human resources to deliver such treatments are limited. This study aimed to evaluate the effectiveness of a web-based intervention with adherence-focused guidance in the treatment of sD. Participants with sD (CES-D≥ 16, no Major Depressive Disorder according to DSM-IV criteria, N = 204) recruited via a large health insurance were randomly allocated to a web-based mobile-supported cognitive-behavioral intervention or to a waitlist control condition with unrestricted access to usual care. The primary outcome was the reduction in depressive symptom severity as measured by blind diagnostic raters using the Quick Inventory of Depressive Symptomatology (QIDS) at posttreatment. There was a statistically significant between-group difference in QIDS scores at posttreatment in favor of the intervention group, F(1, 201) = 11.31, p = .001, corresponding to a medium effect size of d = 0.37 (95% CI 0.09-0.64) and a NNT of 7 (95%-CI 3.7-41.2). Significant effects in favour of the intervention group were also found for secondary outcomes such as quality of life, anxiety, and insomnia severity. Web-based self-help interventions with adherence-focused guidance could be an acceptable and effective approach to reduce a range of negative consequences associated with subclinical depression., (Copyright © 2017. Published by Elsevier Ltd.)

Background: Persons with chronic pain can be treated effectively with acceptance and commitment therapy (ACT). In this trial, we examined the effectiveness of guided and unguided ACT-based online treatment (ACTonPain) for chronic pain patients., Methods: 302 individuals were randomly assigned to ACTonPain with or without guidance (n = 100/101) or to a waiting-list control group (n=101). The primary outcome was pain interference as measured by the Multidimensional Pain Inventory. The secondary outcomes were physical and emotional functioning, pain intensity, ACT process variables, quality of life, satisfaction with the intervention, adherence, and participants' rating of overall improvement. The online measurements were carried out before randomization (T0) and 9 weeks and 6 months after randomization (T1 and T2, respectively). Intention-to-treat (ITT) data analysis was supplemented with additional per-protocol analyses., Results: The guided ACTonPain group showed significantly less pain interference than the control group in the ITT analysis (p = 0.01), with a moderate effect size at T1 and T2 (d = 0.58 respectively), corresponding to a number needed to treat (NNT) of 3.14 for both time points. Participants in the guided ACTonPain group also indicated higher pain acceptance (T1: d = 0.59; T2: d = 0.76). The unguided ACTonPain group showed to be significantly less depressed in comparison to the control group at at time T2 (d = 0.50). No significant differences with respect to effectiveness were found between the two ACTonPain groups (p>0.05)., Conclusion: The online intervention ACTonPain is effective for persons with chronic pain when the program is guided. Further research in a variety of settings of health care is needed in order to determine whether and how ACTonPain can be implemented.

Background: Many studies have provided evidence for the effectiveness of Internet-based stand-alone interventions for mental disorders. A newer form of intervention combines the strengths of face-to-face (f2f) and Internet approaches (blended interventions)., Objective: The aim of this review was to provide an overview of (1) the different formats of blended treatments for adults, (2) the stage of treatment in which these are applied, (3) their objective in combining face-to-face and Internet-based approaches, and (4) their effectiveness., Methods: Studies on blended concepts were identified through systematic searches in the MEDLINE, PsycINFO, Cochrane, and PubMed databases. Keywords included terms indicating face-to-face interventions ("inpatient," "outpatient," "face-to-face," or "residential treatment"), which were combined with terms indicating Internet treatment ("internet," "online," or "web") and terms indicating mental disorders ("mental health," "depression," "anxiety," or "substance abuse"). We focused on three of the most common mental disorders (depression, anxiety, and substance abuse)., Results: We identified 64 publications describing 44 studies, 27 of which were randomized controlled trials (RCTs). Results suggest that, compared with stand-alone face-to-face therapy, blended therapy may save clinician time, lead to lower dropout rates and greater abstinence rates of patients with substance abuse, or help maintain initially achieved changes within psychotherapy in the long-term effects of inpatient therapy. However, there is a lack of comparative outcome studies investigating the superiority of the outcomes of blended treatments in comparison with classic face-to-face or Internet-based treatments, as well as of studies identifying the optimal ratio of face-to-face and Internet sessions., Conclusions: Several studies have shown that, for common mental health disorders, blended interventions are feasible and can be more effective compared with no treatment controls. However, more RCTs on effectiveness and cost-effectiveness of blended treatments, especially compared with nonblended treatments are necessary., (©Doris Erbe, Hans-Christoph Eichert, Heleen Riper, David Daniel Ebert. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 15.09.2017.)

Technology-based approaches for psychosocial diagnostics and interventions provide an attractive opportunity to optimize medical rehabilitation. Based on an Internet- and mobile-based assessment of existing functional health impairments, appropriate planning, implementation of corresponding courses of action as well as outcome assessment can take place. This can be implemented in the form of Internet- and mobile-based interventions (IMI).The present article provides an overview of the basic knowledge of IMI and their evidence base both in general and in particular for their use in medical rehabilitation. Important aspects of internet and mobile-based psycho-social diagnostics are discussed subsequently. Finally, an outlook for the use of Internet- and mobile-based diagnostics and interventions in medical rehabilitation is given.

Background: Stress has been identified as one of the major public health issues in this century. New technologies offer opportunities to provide effective psychological interventions on a large scale., Objective: The aim of this study is to investigate the efficacy of Web- and computer-based stress-management interventions in adults relative to a control group., Methods: A meta-analysis was performed, including 26 comparisons (n=4226). Cohen d was calculated for the primary outcome level of stress to determine the difference between the intervention and control groups at posttest. Analyses of the effect on depression, anxiety, and stress in the following subgroups were also conducted: risk of bias, theoretical basis, guidance, and length of the intervention. Available follow-up data (1-3 months, 4-6 months) were assessed for the primary outcome stress., Results: The overall mean effect size for stress at posttest was Cohen d=0.43 (95% CI 0.31-0.54). Significant, small effects were found for depression (Cohen d=0.34, 95% CI 0.21-0.48) and anxiety (Cohen d=0.32, 95% CI 0.17-0.47). Subgroup analyses revealed that guided interventions (Cohen d=0.64, 95% CI 0.50-0.79) were more effective than unguided interventions (Cohen d=0.33, 95% CI 0.20-0.46; P=.002). With regard to the length of the intervention, short interventions (≤4 weeks) showed a small effect size (Cohen d=0.33, 95% CI 0.22-0.44) and medium-long interventions (5-8 weeks) were moderately effective (Cohen d=0.59; 95% CI 0.45-0.74), whereas long interventions (≥9 weeks) produced a nonsignificant effect (Cohen d=0.21, 95% CI -0.05 to 0.47; P=.006). In terms of treatment type, interventions based on cognitive behavioral therapy (CBT) and third-wave CBT (TWC) showed small-to-moderate effect sizes (CBT: Cohen d=0.40, 95% CI 0.19-0.61; TWC: Cohen d=0.53, 95% CI 0.35-0.71), and alternative interventions produced a small effect size (Cohen d=0.24, 95% CI 0.12-0.36; P=.03). Early evidence on follow-up data indicates that Web- and computer-based stress-management interventions can sustain their effects in terms of stress reduction in a small-to-moderate range up to 6 months., Conclusions: These results provide evidence that Web- and computer-based stress-management interventions can be effective and have the potential to reduce stress-related mental health problems on a large scale., (©Elena Heber, David Daniel Ebert, Dirk Lehr, Pim Cuijpers, Matthias Berking, Stephanie Nobis, Heleen Riper. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 17.02.2017.)

Guided Internet- and mobile-based interventions (IMIs) are an effective and scientifically sound treatment option for depression. Meta-analyses revealed effect sizes comparable to those found for face-to-face treatment as well as pharmacotherapy. Today, most IMIs are based on cognitive behavioral therapy (CBT). While IMIs are well established in healthcare systems of many countries worldwide, Germany is still lagging behind. However, there are an increasing number of model projects trying to implement IMIs into routine healthcare for depression in Germany. Both, service providers and recipients would benefit from transparent quality assurance and data safety guidelines., (© Georg Thieme Verlag KG Stuttgart · New York.)

Study Objectives: Lost productivity caused by insomnia is a common and costly problem for employers. Although evidence for the efficacy of Internet-based cognitive behavioral therapy for insomnia (iCBT-I) already exists, little is known about its economic effects. This study aims to evaluate the cost-effectiveness and cost-benefit of providing iCBT-I to symptomatic employees from the employer's perspective., Methods: School teachers (N = 128) with clinically significant insomnia symptoms and work-related rumination were randomized to guided iCBT-I or a waitlist-control-group, both with access to treatment as usual. Economic data were collected at baseline and 6-mo follow-up. We conducted (1) a cost-effectiveness analysis with treatment response (Reliable Change [decline of 5.01 points] and Insomnia Severity Index < 8 at 6-month follow-up) as the outcome and (2) a cost-benefit analysis. Because both analyses were performed from the employer's perspective, we focused specifically on absenteeism and presenteeism costs. Statistical uncertainty was estimated using bootstrapping., Results: Assuming intervention costs of €200 ($245), cost-effectiveness analyses showed that at a willingness-to-pay of €0 for each positive treatment response, there is an 87% probability that the intervention is more cost effective than treatment as usual alone. Cost-benefit analyses led to a net benefit of €418 (95% confidence interval: -593.03 to 1,488.70) ($512) per participant and a return on investment of 208% (95% confidence interval: -296.52 to 744.35). The reduction in costs was mainly driven by the effects of the intervention on presenteeism and to a lesser degree by reduced absenteeism., Conclusions: Focusing on sleep improvement using iCBT-I may be a cost-effective strategy in occupational health care., Clinical Trials Registration: Title: Online Recovery Training for Better Sleep in Teachers with High Psychological Strain. German Clinical Trial Register (DRKS), URL: https://drks-neu.uniklinik-freiburg.de/drks&#95;web/navigate.do?navigationId=trial.HTML&TRIAL&#95;ID=DRKS00004700. Identifier: DRKS00004700., Commentary: A commentary on this article appears in this issue on page 1767., (© 2016 Associated Professional Sleep Societies, LLC.)

Objective: This randomized controlled trial (RCT) aimed to evaluate the efficacy of an internet-based stress management intervention (iSMI) among employees compared to a 6-month waitlist control group (WLC) with full access to treatment-as-usual., Method: A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale, PSS-10 ≥22) was assigned to either the iSMI or WLC group. The iSMI consisted of seven sessions and one booster session including problem-solving and emotion regulation techniques. Participants received guidance from an e-coach that focused on improving the adherence to the intervention. Self-report data were assessed at baseline, seven weeks, and six months following randomization. The primary outcome was perceived stress (PSS-10). The secondary outcomes included other relevant mental and work-related health outcomes., Results: The iSMI participants showed a significantly higher reduction in perceived stress from baseline to seven weeks [d=0.79, 95% confidence interval (95% CI) 0.54-1.04] and the 6-month follow up (d=0.85, 95% CI 0.59-1.10) compared to controls. Significant moderate-to-large effect sizes were also found for depression, anxiety, emotional exhaustion, sleeping problems, worrying, quality of life (mental health), psychological detachment and emotion regulation skills. Work engagement, quality of life (physical health), absenteeism and presenteeism were not found to significantly differ between the iSMI and WLC groups. Changes in emotion regulation regarding general distress mediated changes in perceived stress., Conclusion: The iSMI investigated in this study was found to be effective in reducing typical symptoms of stress. However, several important work-related health symptoms were not significantly affected by the intervention. Internet-based guided self-help interventions could be an acceptable, effective approach to reduce a range of negative consequences associated with work-related stress. Future studies should investigate the comparative (cost-) effectiveness of guided and unguided stress management interventions.

Background: The perspective of users should be taken into account in the evaluation of Web-based health interventions. Assessing the users' satisfaction with the intervention they receive could enhance the evidence for the intervention effects. Thus, there is a need for valid and reliable measures to assess satisfaction with Web-based health interventions., Objective: The objective of this study was to analyze the reliability, factorial structure, and construct validity of the Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I)., Methods: The psychometric quality of the CSQ-I was analyzed in user samples from 2 separate randomized controlled trials evaluating Web-based health interventions, one from a depression prevention intervention (sample 1, N=174) and the other from a stress management intervention (sample 2, N=111). At first, the underlying measurement model of the CSQ-I was analyzed to determine the internal consistency. The factorial structure of the scale and the measurement invariance across groups were tested by multigroup confirmatory factor analyses. Additionally, the construct validity of the scale was examined by comparing satisfaction scores with the primary clinical outcome., Results: Multigroup confirmatory analyses on the scale yielded a one-factorial structure with a good fit (root-mean-square error of approximation =.09, comparative fit index =.96, standardized root-mean-square residual =.05) that showed partial strong invariance across the 2 samples. The scale showed very good reliability, indicated by McDonald omegas of .95 in sample 1 and .93 in sample 2. Significant correlations with change in depressive symptoms (r=-.35, P<.001) and perceived stress (r=-.48, P<.001) demonstrated the construct validity of the scale., Conclusions: The proven internal consistency, factorial structure, and construct validity of the CSQ-I indicate a good overall psychometric quality of the measure to assess the user's general satisfaction with Web-based interventions for depression and stress management. Multigroup analyses indicate its robustness across different samples. Thus, the CSQ-I seems to be a suitable measure to consider the user's perspective in the overall evaluation of Web-based health interventions., Competing Interests: Conflicts of Interest: None declared.

Background: Nonadherence to treatment is a prevalent issue in Internet interventions. Guidance from health care professionals has been found to increase treatment adherence rates in Internet interventions for a range of physical and mental disorders. Evaluating different guidance formats of varying intensity is important, particularly with respect to improvement of effectiveness and cost-effectiveness. Identifying predictors of nonadherence allows for the opportunity to better adapt Internet interventions to the needs of participants especially at risk for discontinuing treatment., Objective: The goal of this study was to investigate the influence of different guidance formats (content-focused guidance, adherence-focused guidance, and administrative guidance) on adherence and to identify predictors of nonadherence in an Internet-based mobile-supported stress management intervention (ie, GET.ON Stress) for employees., Methods: The data from the groups who received the intervention were pooled from three randomized controlled trials (RCTs) that evaluated the efficacy of the same Internet-based mobile-supported stress management intervention (N=395). The RCTs only differed in terms of the guidance format (content-focused guidance vs waitlist control, adherence-focused guidance vs waitlist control, administrative guidance vs waitlist control). Adherence was defined by the number of completed treatment modules (0-7). An ANOVA was performed to compare the adherence rates from the different guidance formats. Multiple hierarchical linear regression analysis was conducted to evaluate predictors of nonadherence, which included gender, age, education, symptom-related factors, and hope for improvement., Results: In all, 70.5% (93/132) of the content-focused guidance sample, 68.9% (91/132) of the adherence-focused guidance sample, and 42.0% (55/131) of the participants in the administrative guidance sample completed all treatment modules. Guidance had a significant effect on treatment adherence (F2,392=11.64, P<.001; ω(2)=.05). Participants in the content-focused guidance (mean 5.70, SD 2.32) and adherence-focused guidance samples (mean 5.58, SD 2.33) completed significantly more modules than participants in the administrative guidance sample (mean 4.36, SD 2.78; t223=4.53, P<.001; r=.29). Content-focused guidance was not significantly associated with higher adherence compared to adherence-focused guidance (t262=0.42, P=.67; r=.03). The effect size of r=.03 (95% CI -0.09 to 0.15) did not pass the equivalence margin of r=.20 and the upper bound of the 95% CI lay below the predefined margin, indicating equivalence between adherence-focused guidance and content-focused guidance. Beyond the influence of guidance, none of the predictors significantly predicted nonadherence., Conclusions: Guidance has been shown to be an influential factor in promoting adherence to an Internet-based mobile-supported stress management intervention. Adherence-focused guidance, which included email reminders and feedback on demand, was equivalent to content-focused guidance with regular feedback while requiring only approximately a quarter of the coaching resources. This could be a promising discovery in terms of cost-effectiveness. However, even after considering guidance, sociodemographic, and symptom-related characteristics, most interindividual differences in nonadherence remain unexplained., Clinical Trial: DRKS00004749; http://drks-neu.uniklinik-freiburg.de/drks&#95;web/navigate.do?navigationId=trial.HTML&TRIAL &#95;ID=DRKS00004749 (Archived by WebCite at http://www.webcitation.org/6QiDk9Zn8); DRKS00005112; http://drks-neu.uniklinik-freiburg. de/drks&#95;web/navigate.do?navigationId=trial.HTML&TRIAL&#95;ID=DRKS00005112 (Archived by WebCite at http://www.webcitation.org/6QiDysvev); DRKS00005384; http://drks-neu.uniklinik-freiburg.de/ drks&#95;web/navigate.do?navigationId=trial.HTML&TRIAL&#95;ID=DRKS00005384 (Archived by WebCite at http://www.webcitation.org/6QiE0xcpE).

Importance: Evidence-based treatments for major depressive disorder (MDD) are not very successful in improving functional and health outcomes. Attention has increasingly been focused on the prevention of MDD., Objective: To evaluate the effectiveness of a web-based guided self-help intervention for the prevention of MDD., Design, Setting, and Participants: Two-group randomized clinical trial conducted between March 1, 2013, and March 4, 2015. Participants were recruited in Germany from the general population via a large statutory health insurance company (ie, insurance funded by joint employer-employee contributions). Participants included 406 self-selected adults with subthreshold depression (Centre for Epidemiologic Studies Depression Scale score ≥16, no current MDD according to Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition, Text Revision] criteria)., Interventions: All participants had unrestricted access to usual care (visits to the primary care clinician) and were randomized to either a web-based guided self-help intervention (cognitive-behavioral and problem-solving therapy supported by an online trainer; n = 202) or a web-based psychoeducation program (n = 204)., Main Outcomes and Measures: The primary outcome was time to onset of MDD in the intervention group relative to the control group over a 12-month follow-up period as assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment., Results: Among 406 randomized patients (mean age, 45 years; 73.9% women), 335 (82%) completed the telephone follow-up at 12 months. Fifty-five participants (27%) in the intervention group experienced MDD compared with 84 participants (41%) in the control group. Cox regression analyses controlling for baseline depressive symptom severity revealed a hazard ratio of 0.59 (95% CI, 0.42-0.82; P = .002) at 12-month follow-up. The number needed to treat to avoid 1 new case of MDD was 5.9 (95% CI, 3.9-14.6)., Conclusions and Relevance: Among patients with subthreshold depression, the use of a web-based guided self-help intervention compared with enhanced usual care reduced the incidence of MDD over 12 months. Further research is needed to understand whether the effects are generalizable to both first onset of depression and depression recurrence as well as efficacy without the use of an online trainer., Trial Registration: German Clinical Trial Registry Identifier: DRKS00004709.

Objective: This randomised controlled trial (RCT) aimed to evaluate the efficacy of a self-guided internet-based stress management intervention (iSMI) for employees compared to a 6-month wait-list control group (WLC) with full access for both groups to treatment as usual., Method: A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale, PSS-10 ≥22) was randomly assigned to either the iSMI or to the WLC. The iSMI consisted of seven sessions and one booster session including problem-solving and emotion regulation techniques. Self-report data were assessed at baseline, at 7 weeks and at 6 months following randomisation. The primary outcome was perceived stress (PSS-10). The secondary outcomes included other relevant mental-related and work-related health outcomes. Data were analysed based on intention-to-treat principles., Results: The iSMI participants showed a significantly higher reduction in perceived stress from baseline to post-treatment at 7 weeks (d=0.96, 95% CI 0.70 to 1.21) and to the 6-month follow-up (d=0.65, 95% CI 0.40 to 0.89) compared to the WLC. Significant differences with small to moderate effect sizes were also found for depression, anxiety, emotional exhaustion, sleeping problems, worrying, mental health-related quality of life, psychological detachment, emotion regulation skills and presenteeism, in favour of the experimental group. At the 6 -month follow-up, all outcomes remained significantly better for the experimental group with the exception of work engagement, physical health-related quality of life and absenteeism, which were not found to significantly differ between the iSMI and WLC groups., Conclusions: The iSMI investigated in this study was found to be effective in reducing typical mental-related and work-related health symptoms of stressed employees. Internet-based self-guided interventions could be an acceptable, effective and potentially cost-effective approach to reduce the negative consequences associated with work-related stress., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: Work-related stress is highly prevalent among employees and is associated with adverse mental health consequences. Web-based interventions offer the opportunity to deliver effective solutions on a large scale; however, the evidence is limited and the results conflicting., Objective: This randomized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees., Methods: A total of 264 employees with elevated symptoms of stress (Perceived Stress Scale-10, PSS-10≥22) were recruited from the general working population and randomly assigned to an Internet-based stress management intervention (iSMI) or waitlist control group. The intervention (GET.ON Stress) was based on Lazarus's transactional model of stress, consisted of seven sessions, and applied both well-established problem solving and more recently developed emotion regulation strategies. Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI. Participants received written feedback on every completed session from an e-coach. The primary outcome was perceived stress (PSS-10). Web-based self-report assessments for both groups were scheduled at baseline, 7 weeks, and 6 months. At 12 months, an extended follow-up was carried out for the iSMI group only., Results: An intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest (F1,261=58.08, P<.001; Cohen's d=0.83) and at the 6-month follow-up (F1,261=80.17, P<.001; Cohen's d=1.02). The effects in the iSMI group were maintained at 12-month follow-up., Conclusions: This Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term. Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions., Trial Registration: German Clinical Trials Register (DRKS): 00004749; http://drks-neu.uniklinik-freiburg.de/ drks&#95;web/setLocale&#95;EN.do (Archived by WebCite at http://www.webcitation.org/6e8rl98nl).

Background: Problematic alcohol consumption is associated with a high disease burden for affected individuals and has a detrimental impact on companies and society due to direct and indirect health costs. This protocol describes a study design to evaluate the (cost)-effectiveness of a guided and unguided Internet-based self-help intervention for employees called "GET.ON Clever weniger trinken" (be smart - drink less) compared to a waiting list control group., Methods: In a three-arm randomized controlled trial, 528 German adults who are currently members of the workforce will be recruited by occupational health departments of major health insurance companies. Employees aged 18 and older displaying problematic drinking patterns (>21/14 drinks per week and an AUDIT score > 8/6 for men/women) will be randomly assigned to one of three following study conditions: 1. unguided web-based self-help for problematic drinking, 2. adherence-focused guided self-help, and 3. waiting list control. Self-report data will be collected at baseline (T1), 6 weeks (T2), and 6 months (T3) after randomization. The primary outcome will be the reduction of alcohol standard units during the 7 days prior to T2, using the Timeline Followback method. Cost-effectiveness analyses to determine direct and indirect costs will be conducted from the perspectives of employers and the society. Data will be analyzed on an intention-to-treat basis and per protocol., Discussion: There is a need to identify effective low-threshold solutions to improve ill-health and reduce the negative economic consequences due to problematic alcohol drinking in workforces. If the proposed web-based intervention proves both to be efficacious and cost-effective, it may be a useful tool to increase utilization rates of interventions for problematic drinking in occupational settings., Trial Registration: German Register of Clinical Studies (DRKS): DRKS00006105 , date of registration: 2014-07-07.

Background and Aims: Internet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized controlled trials in four languages. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before (i.e. Romania)., Methods: Participants (n = 76) were recruited, screened and randomized to either a nine-week guided iCBT or a wait-list control group in April and May 2012. Self-report measures were collected before (April 2012) and after the intervention (July 2012), as well as six months later (January 2013). Although social anxiety was assessed with multiple measures, the Liebowitz Social Anxiety Scale - Self Report version (LSAS-SR) and Social Phobia Inventory (SPIN) were used as the primary outcome measures., Results: A significant difference with a large between-group effect size in favor of iCBT was found (Cohen's d = 1.19 for LSAS-SR and d = 1.27 for SPIN). Recovery rates show that 36.8% (n = 14) in the treatment group score below the SPIN clinical cut-off compared to only 2.6% (n = 1) in the wait-list control group. Post-intervention clinical interviews also revealed that 34.2% (n = 13) of the treatment group was completely recovered (full remission) while additionally 36.8% (n = 14) retained some social anxiety symptoms (partial remission). However, an important study limitation is that post-intervention interviewers were not blinded to the study conditions. The program also effectively reduced depression and dysfunctional thinking (between-group Cohen's d = 0.84 for depression and d = 0.63 for dysfunctional thinking). Moreover, the iCBT intervention appears to have a long-term impact for participants' functioning, as the treatment gains were maintained six months later., Conclusions: Internet-delivered interventions display a high potential to quickly and widely disseminate effective evidence-based programs around the world. This study provides support for guided iCBT as a promising treatment approach in Romania., Trial Registration: ClinicalTrials.gov NCT01557894.

Objective: Depression is common in diabetes and linked to adverse health outcomes. This study evaluated the efficacy of a guided web-based intervention in reducing depression in adults with type 1 and type 2 diabetes., Research Design and Methods: A total of 260 participants with diabetes and elevated depressive symptoms (Center for Epidemiologic Studies Depression Scale [CES-D ≥23]) were randomly assigned to the GET.ON Mood Enhancer Diabetes (a guided self-help intervention, n = 130) or a brief online unguided psychoeducation program for depression (n = 130). The primary outcome was depressive symptoms severity (CES-D). The secondary outcomes included diabetes-specific emotional distress (Problem Areas in Diabetes [PAID] scale) and participant satisfaction (adaption CSQ-8). Data were collected at baseline and 2 months after randomization. To identify differences in outcome between the groups, we used analyses of covariance with the baseline CES-D score as covariate on both intent-to-treat (ITT) and per-protocol (PP) basis., Results: Compared with the control group, the intervention group showed significantly less depressive symptom severity at posttreatment based on ITT (d = 0.89) and PP analyses (d = 1.00). The intervention participants displayed a significantly larger reduction in diabetes-specific emotional distress (d = 0.58, ITT). The intervention appeared to be acceptable to the participants; 95% (n = 121) would recommend the training to a friend with diabetes in need of psychological help., Conclusions: A guided, web-based intervention to reduce depression in adults with type 1 and type 2 diabetes is effective in reducing both depressive symptoms and diabetes-specific emotional distress., (© 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.)

Background: Anxiety and depression in children and adolescents are undertreated. Computer- and Internet-based cognitive behavioral treatments (cCBT) may be an attractive treatment alternative to regular face-to-face treatment.This meta-analysis aims to evaluate whether cCBT is effective for treating symptoms of anxiety and depression in youth., Methods and Findings: We conducted systematic searches in bibliographical databases (Pubmed, Cochrane controlled trial register, PsychInfo) up to December 4, 2013. Only randomized controlled trials in which a computer-, Internet- or mobile-based cognitive behavioral intervention targeting either depression, anxiety or both in children or adolescents up to the age of 25 were compared to a control condition were selected. We employed a random-effects pooling model in overall effect analyses and a mixed effect model for sub-group analyses. Searches resulted in identifying 13 randomized trials, including 796 children and adolescents that met inclusion criteria. Seven studies were directed at treating anxiety, four studies at depression, and two were of a transdiagnostic nature, targeting both anxiety and depression. The overall mean effect size (Hedges' g) of cCBT on symptoms of anxiety or depression at post-test was g=0.72 (95% CI:0.55-0.90, numbers needed to be treated (NNT)=2.56). Heterogeneity was low (I²=20.14%, 95% CI: 0-58%). The superiority of cCBT over controls was evident for interventions targeting anxiety (g=0.68; 95% CI: 0.45-0.92; p < .001; NNT=2.70) and for interventions targeting depression (g=0.76; 95% CI: 0.41-0.12; p < .001; NNT=2.44) as well as for transdiagnostic interventions (g=0.94; 95% CI: 0.23-2.66; p < .001; NNT=2.60)., Conclusions: Results provide evidence for the efficacy of cCBT in the treatment of anxiety and depressive symptoms in youth. Hence, such interventions may be a promising treatment alternative when evidence based face-to-face treatment is not feasible. Future studies should examine long-term effects of treatments and should focus on obtaining patient-level data from existing studies, to perform an individual patient data meta-analysis.

Objectives: The primary purpose of this randomized controlled trial (RCT) was to evaluate the efficacy of a guided internet-based recovery training for employees who suffer from both work-related strain and sleep problems (GET.ON Recovery). The recovery training consisted of six lessons, employing well-established methods from cognitive behavioral therapy for insomnia (CBT-I) such as sleep restriction, stimulus control, and hygiene interventions as well as techniques targeted at reducing rumination and promoting recreational activities., Methods: In a two-arm RCT (N=128), the effects of GET.ON Recovery were compared to a waitlist-control condition (WLC) on the basis of intention-to-treat analyses. German teachers with clinical insomnia complaints (Insomnia Severity Index ≥15) and work-related rumination (Irritation Scale, cognitive irritation subscale ≥15) were included. The primary outcome measure was insomnia severity., Results: Analyses of covariance (ANCOVA) revealed that, compared to the WLC, insomnia severity of the intervention group decreased significantly stronger (F=74.11, P<0.001) with a d=1.45 [95% confidence interval (95% CI) 1.06-1.84] The number needed to treat (NNT) was <2 for reliable change and NNT <4 for reduction in expert-rated diagnosis of primary insomnia., Conclusion: The training significantly reduces sleep problems and fosters mental detachment from work and recreational behavior among adult stressed employees at post-test and 6-months follow up. Given the low threshold access this training could reach out to a large group of stressed employees when results are replicated in other studies.

Background: Recently, internet-based interventions have been proposed as effective treatments for people with panic disorder (PD). However, little is known about the clinical effects of integrating mobile technology into these interventions. Because users carry their smartphones with them throughout the day, we hypothesize that this technology can be used to significantly support individuals with monitoring and overcoming their PD symptoms. The aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed hybrid intervention that combines internet/PC with smartphone delivery to treat the symptoms of PD. The intervention is based on cognitive behavioral therapy and consists of six modules over a total of six weeks., Methods/design: A two-arm randomized controlled trial (RCT) will be conducted to evaluate the effects of a hybrid online training module for PD. Based on a power calculation (d =0.60; 1-β of 80%; α =0.05), 90 participants with mild to moderate panic symptoms with or without agoraphobia (as assessed by the Panic and Agoraphobia Scale) will be recruited from the general population and randomly assigned to either the intervention group or a six-month waitlist control group. The primary outcome measure will be the severity of panic symptoms. Secondary outcomes will include depression, quality of life, and an observer-based rating of panic severity. Furthermore, data regarding acceptance and the usability of the smartphone app will be assessed. Assessments will take place at baseline as well as eight weeks, three months, and six months after randomization. Moreover, a cost-effectiveness analysis will be performed from a societal perspective. Data will be analyzed on an intention-to-treat basis and per protocol., Discussion: To our knowledge, this RCT is one of the first to examine the efficacy of a hybrid online training for adult PD. This study seeks to contribute to the emerging field of hybrid online training. If the intervention is efficacious, then research on this hybrid online training should be extended. The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults., Trial Registration: German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).

Objective: The primary purpose of this randomized controlled trial (RCT) was to evaluate the efficacy of internet-based problem-solving training (iPST) for employees in the educational sector (teachers) with depressive symptoms. The results of training were compared to those of a waitlist control group (WLC)., Methods: One-hundred and fifty teachers with elevated depressive symptoms (Center for Epidemiologic Studies Depression Scale, CES-D ≥16) were assigned to either the iPST or WLC group. The iPST consisted of five lessons, including problem-solving and rumination techniques. Symptoms were assessed before the intervention began and in follow-up assessments after seven weeks, three months, and six months. The primary outcome was depressive symptom severity (CES-D). Secondary outcomes included general and work-specific self-efficacy, perceived stress, pathological worries, burnout symptoms, general physical and mental health, and absenteeism., Results: iPST participants displayed a significantly greater reduction in depressive symptoms after the intervention (d=0.59, 95% CI 0.26-0.92), after three months (d=0.37, 95% CI 0.05-0.70) and after six months (d=0.38, 95% CI 0.05-0.70) compared to the control group. The iPST participants also displayed significantly higher improvements in secondary outcomes. However, workplace absenteeism was not significantly affected., Conclusion: iPST is effective in reducing symptoms of depression among teachers. Disseminated on a large scale, iPST could contribute to reducing the burden of stress-related mental health problems among teachers. Future studies should evaluate iPST approaches for use in other working populations.

Background: Internet- and mobile based stress-management interventions (iSMI) may be an effective means to address the negative consequences of occupational stress. However, available results from randomised controlled trials are conflicting. Moreover, it is yet not clear whether guided or unguided self-help iSMI provide better value for money. Internet-based mental health interventions without guidance are often much less effective than interventions including at least some guidance from a professional. However, direct comparisons in randomised controlled trials are scarce and, to the best of our knowledge, the comparative (cost)-effectiveness of guided vs. unguided iSMI has not yet been studied. Hence, this study investigates the acceptability and (cost-) effectiveness of minimal guided and unguided iSMI in employees with heightened levels of perceived stress., Methods: A three-armed randomised controlled trial (RCT) will be conducted to compare a minimal guided and unguided iSMI with a waiting list control condition (WLC). Both active conditions are based on the same iSMI, i.e. GET.ON Stress, and differ only with regard to the guidance format. Employees with heightened levels of perceived stress (PSS ≥ 22) will be randomised to one of three conditions. Primary outcome will be comparative changes in perceived stress (PSS). Secondary outcomes include changes in self-reported depression, work-engagement, presenteeism and absenteeism. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective, including both direct medical costs and costs related to productivity losses. In addition, a cost-benefit analysis will be conducted from the employer's perspective. Incremental net-benefit regression analyses will address the question if there are any baseline factors (i.e. subgroups of employees) associated with particularly favorable cost-effectiveness when the experimental intervention is offered. Assessments take place at baseline, 7 weeks post-treatment and 6 months after randomisation., Discussion: Online-based (guided) self-help interventions could be an acceptable, effective and economically sustainable approach to offer evidence-based intervention alternatives to reduce the negative consequences associated with work-related stress. This study evaluates the (cost-) effectiveness of two versions of an iSMI, minimal guided and unguided iSMI. Thus, the present study will further enhance the evidence-base for iSMI and provide valuable information about the optimal balance between outcome and economic costs., Trial Registration: German Clinical Trial Registration (DRKS): DRKS00005687.

Background: Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. A large number of randomised controlled trials (RCTs) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression. However, study quality varies considerably. The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention (GET.ON Mood Enhancer) compared to online-based psychoeducation in an investigator-blinded RCT., Methods/design: A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression (OPD). Both treatment groups will have full access to treatment as usual. Adults with MDD (n=128) will be recruited and randomised to one of the two conditions. Primary outcome will be observer-rated depressive symptoms (HRSD-24) by independent assessors blind to treatment conditions. Secondary outcomes include changes in self-reported depressive symptom severity, anxiety and quality of life. Additionally, potential negative effects of the treatments will systematically be evaluated on several dimensions (for example, symptom deteriorations, attitudes toward seeking psychological help, relationships and stigmatisation). Assessments will take place at baseline, 6 and 12 weeks after randomisation., Discussion: This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition (psychoeducation-control) and an independent, blinded outcome evaluation. This study will further enhance the evidence for Internet-based guided self-help interventions for MDD., Trial Registration: German Clinical Trial Registration (DRKS): DRKS00005025.

Background: Major depressive disorder (MDD) is a prevalent and severe disorder. Although effective treatments for MDD are available, many patients remain untreated, mainly because of insufficient treatment capacities in the health care system. Resulting waiting periods are often associated with prolonged suffering and impairment as well as a higher risk of chronification. Web-based interventions may help to alleviate these problems. Numerous studies provided evidence for the efficacy of web-based interventions for depression. The aim of this study is to evaluate a new web-based guided self-help intervention (GET.ON-Mood Enhancer-WL) specifically developed for patients waiting to commence inpatient therapy for MDD., Methods: In a two-armed randomised controlled trial (n = 200), the web-based guided intervention GET.ON-Mood Enhancer-WL in addition to treatment as usual (TAU) will be compared with TAU alone. The intervention contains six modules (psycho education, behavioural activation I & II, problem solving I & II, and preparation for subsequent inpatient depression therapy). The participants will be supported by an e-coach, who will provide written feedback after each module. Inclusion criteria include a diagnosis of MDD assessed with a structured clinical interview [SCID] and a waiting period of at least three weeks before start of inpatient treatment. The primary outcome is observer-rated depressive symptom severity (HRSD24). Further (explorative) questions include whether remission will be achieved earlier and by more patients during inpatient therapy because of the web-based preparatory intervention., Discussion: If GET.ON-Mood Enhancer-WL is proven to be effective, patients may start inpatient therapy with reduced depressive symptom severity, ideally leading to higher remission rates, shortened inpatient therapy, reduced costs, and decreased waiting times., Trial Registration: German Clinical Trial Registration (DRKS): DRKS00004708.

Background: Recent studies provide evidence for the effectiveness of Internet-based maintenance treatments for mental disorders. However, it is still unclear which participants might or might not profit from this particular kind of treatment delivery., Objective: The study aimed to identify moderators of treatment outcome in a transdiagnostic Internet-based maintenance treatment (TIMT) offered to patients after inpatient psychotherapy for mental disorders in routine care., Methods: Using data from a randomized controlled trial (N=400) designed to test the effectiveness of TIMT, we performed secondary analyses to identify factors moderating the effects of TIMT (intervention) when compared with those of a treatment-as-usual control condition. TIMT involved an online self-management module, asynchronous patient-therapist communication, a peer support group, and online-based progress monitoring. Participants in the control condition had unstructured access to outpatient psychotherapy, standardized outpatient face-to-face continuation treatment, and psychotropic management. Self-reports of psychopathological symptoms and potential moderators were assessed at the start of inpatient treatment (T1), at discharge from inpatient treatment/start of TIMT (T2), and at 3-month (T3) and 12-month follow-up (T4)., Results: Education level, positive outcome expectations, and diagnoses significantly moderated intervention versus control differences regarding changes in outcomes between T2 and T3. Only education level moderated change differences between T2 and T4. The effectiveness of the intervention (vs control) was more pronounced among participants with a low (vs high) education level (T2-T3: B=-0.32, SE 0.16, P=.049; T2-T4: B=-0.42, SE 0.21, P=.049), participants with high (vs low) positive outcome expectations (T2-T3: B=-0.12, SE 0.05, P=.02) and participants with anxiety disorder (vs mood disorder) (T2-T3: B=-0.43, SE 0.21, P=.04). Simple slope analyses revealed that despite some subgroups benefiting less from the intervention than others, all subgroups still benefited significantly., Conclusions: This transdiagnostic Internet-based maintenance treatment might be suitable for a wide range of participants differing in various clinical, motivational, and demographic characteristics. The treatment is especially effective for participants with low education levels. These findings may generalize to other Internet-based maintenance treatments.

Background: Internet-based guided self-help is efficacious for panic disorder, but it is not known whether such treatment is effective for milder panic symptoms as well., Objective: To evaluate the effectiveness of Don't Panic Online, an Internet-based self-help course for mild panic symptoms, which is based on cognitive behavioral principles and includes guidance by email., Methods: A pragmatic randomized controlled trial was conducted. Participants (N=126) were recruited from the general population and randomized to either the intervention group or to a waiting-list control group. Inclusion criteria were a Panic Disorder Severity Scale-Self Report (PDSS-SR) score between 5-15 and no suicide risk. Panic symptom severity was the primary outcome measure; secondary outcome measures were anxiety and depressive symptom severity. Measurements were conducted online and took place at baseline and 12 weeks after baseline (T1). At baseline, diagnoses were obtained by telephone interviews., Results: Analyses of covariance (intention-to-treat) showed no significant differences in panic symptom reduction between groups. Completers-only analyses revealed a moderate effect size in favor of the intervention group (Cohen's d=0.73, P=.01). Only 27% of the intervention group finished lesson 4 or more (out of 6). Nonresponse at T1 was high for the total sample (42.1%). Diagnostic interviews showed that many participants suffered from comorbid depression and anxiety disorders., Conclusions: The Internet-based guided self-help course appears to be ineffective for individuals with panic symptoms. However, intervention completers did derive clinical benefits from the intervention., Trial Registration: Nederlands Trial Register: NTR1639; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1639 (Archived by WebCite at http://www.webcitation.org/6ITZPozs9).

Background: Work-related stress is associated with a variety of mental and emotional problems and can lead to substantial economic costs due to lost productivity, absenteeism or the inability to work. There is a considerable amount of evidence on the effectiveness of traditional face-to-face stress-management interventions for employees; however, they are often costly, time-consuming, and characterized by a high access threshold. Web-based interventions may overcome some of these problems yet the evidence in this field is scarce. This paper describes the protocol for a study that will examine the efficacy and cost-effectiveness of a web-based guided stress-management training which is based on problem solving and emotion regulation and aimed at reducing stress in adult employees., Methods: The study will target stressed employees aged 18 and older. A randomized controlled trial (RCT) design will be applied. Based on a power calculation of d=.35 (1-β of 80%, α = .05), 264 participants will be recruited and randomly assigned to either the intervention group or a six-month waitlist control group. Inclusion criteria include an elevated stress level (Cohen's Perceived Stress Scale-10 ≥ 22) and current employment. Exclusion criteria include risk of suicide or previously diagnosed psychosis or dissociative symptoms. The primary outcome will be perceived stress, and secondary outcomes include depression and anxiety. Data will be collected at baseline and seven weeks and six months after randomization. An extended follow up at 12 months is planned for the intervention group. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective and will include both direct and indirect health care costs. Data will be analyzed on an intention-to-treat basis and per protocol., Discussion: The substantial negative consequences of work-related stress emphasize the necessity for effective stress-management trainings. If the proposed internet intervention proves to be (cost-) effective, a preventative, economical stress-management tool will be conceivable. The strengths and limitations of the present study are discussed., Trial Registration: German Register of Clinical Studies (DRKS): DRKS00004749.

Background: Insomnia and work-related stress often co-occur. Both are associated with personal distress and diminished general functioning, as well as substantial socio-economic costs due to, for example, reduced productivity at the work place and absenteeism. Insomnia complaints by people experiencing work-related stress are correlated with a deficient cognitive detachment from work. Diffuse boundaries between work and private life can additionally complicate the use of recreational activities that facilitate cognitive detachment.Cognitive behavioral therapy for insomnia is effective but rarely implemented. Internet-based cognitive behavioral therapy for insomnia could potentially reduce this deficit given its demonstrated effectiveness. Less is known, however, about the efficacy of internet-based cognitive behavioral therapy for insomnia in populations affected by high work stress. Thus, the aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed, guided online training which is based on Cognitive Behavioral Therapy for insomnia and tailored to teachers affected by occupational stress., Methods/design: In a two-arm randomized controlled trial (N = 128), the effects of a guided online sleep training will be compared to a waitlist-control condition. German teachers with significant clinical insomnia complaints (Insomnia Severity Index ≥ 15) and work-related rumination (Irritation Scale, subscale Cognitive Irritation ≥ 15) will be included in the study. The primary outcome measure will be insomnia severity. Additionally, an economic evaluation from a societal perspective will be conducted. Data from the intention-to-treat sample will be analyzed two and six months after randomization., Discussion: To the best of our knowledge, this is the first study to evaluate an online sleep training tailored to a specific population with work stress, that is, teachers. If this type of intervention is effective, it could reduce the paucity of cognitive behavioral therapy for insomnia and augment the support for teachers in coping with their insomnia problems., Trial Registration: German Clinical Trial Register (DRKS): DRKS00004700.

Background: Mental disorders are highly prevalent among university students. Distance-learning students are particularly burdened and have limited access to conventional university health services. Interventions for stress are sought after in distance learners and may help increase treatment coverage. Internet-based interventions have been shown to be effective in preventing and treating depression, but it remains unclear if interventions directed at academic stress also have this potential.Aim: The trial presented here investigates the effectiveness of an Internet- and App-based stress intervention in distance-learning students with elevated levels of depression.Methods: A sample of N = 200 students of a large German distance university with elevated levels of depression [Center for Epidemiological Studies’ Depression Scale (CES-D) ≥ 16] will be randomly assigned to either an Internet- and App-based stress management intervention group (IG) or a control group (CG) receiving an Internet-based psychoeducational program for academic stress. The IG consists of eight Internet-based sessions promoting stress management skills using cognitive–behavioral and problem-solving techniques. A mobile App will be employed to facilitate training transfer. Self-report data will be assessed at baseline (T0), post-treatment (T1; 7 weeks), and 3-month follow-up (T2). Potential moderators will be assessed at baseline. The primary outcome is depression (CES-D) post-treatment. Secondary outcomes include mental health outcomes, modifiable risk and protective factors, and academic outcomes. Data will be analyzed on an intention-to-treat principle along with sensitivity analyses to assess the robustness of findings. Additional health economic analyses will be conducted.Discussion: Results will provide the basis to assess the acceptance and effectiveness of Internet-delivered stress interventions in distance-learning students with symptoms of depression.Ethics and dissemination: The study has been reviewed and approved by the University of Erlangen-Nuremberg ethics committee (Erlangen, Germany; 33_17 Bc). Results of the study will be disseminated through peer-reviewed publications.Trial Registration:German Clinical Trial Registration (DRKS), identifier DRKS00011800

OBJECTIVE: This randomized controlled trial (RCT) aimed to evaluate the efficacy of an internet-based stress management intervention (iSMI) among employees compared to a 6-month waitlist control group (WLC) with full access to treatment-as-usual. METHOD: A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale, PSS-10 ≥22) was assigned to either the iSMI or WLC group. The iSMI consisted of seven sessions and one booster session including problem-solving and emotion regulation techniques. Participants received guidance from an e-coach that focused on improving the adherence to the intervention. Self-report data were assessed at baseline, seven weeks, and six months following randomization. The primary outcome was perceived stress (PSS-10). The secondary outcomes included other relevant mental and work-related health outcomes. RESULTS: The iSMI participants showed a significantly higher reduction in perceived stress from baseline to seven weeks [d=0.79, 95% confidence interval (95% CI) 0.54–1.04] and the 6-month follow up (d=0.85, 95% CI 0.59–1.10) compared to controls. Significant moderate-to-large effect sizes were also found for depression, anxiety, emotional exhaustion, sleeping problems, worrying, quality of life (mental health), psychological detachment and emotion regulation skills. Work engagement, quality of life (physical health), absenteeism and presenteeism were not found to significantly differ between the iSMI and WLC groups. Changes in emotion regulation regarding general distress mediated changes in perceived stress. CONCLUSION: The iSMI investigated in this study was found to be effective in reducing typical symptoms of stress. However, several important work-related health symptoms were not significantly affected by the intervention. Internet-based guided self-help interventions could be an acceptable, effective approach to reduce a range of negative consequences associated with work-related stress. Future studies should investigate the comparative (cost-) effectiveness of guided and unguided stress management interventions.

OBJECTIVES: The primary purpose of this randomized controlled trial (RCT) was to evaluate the efficacy of a guided internet-based recovery training for employees who suffer from both work-related strain and sleep problems (GET.ON Recovery). The recovery training consisted of six lessons, employing well-established methods from cognitive behavioral therapy for insomnia (CBT-I) such as sleep restriction, stimulus control, and hygiene interventions as well as techniques targeted at reducing rumination and promoting recreational activities. METHODS: In a two-arm RCT (N=128), the effects of GET.ON Recovery were compared to a waitlist-control condition (WLC) on the basis of intention-to-treat analyses. German teachers with clinical insomnia complaints (Insomnia Severity Index ≥15) and work-related rumination (Irritation Scale, cognitive irritation subscale ≥15) were included. The primary outcome measure was insomnia severity. RESULTS: Analyses of covariance (ANCOVA) revealed that, compared to the WLC, insomnia severity of the intervention group decreased significantly stronger (F=74.11, P